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Human Genetics, the Case of Therapeutic Cloning Human Genetics, The case of therapeutic cloning Where to go with human genetics? V.C. Leijten June 2009 Human Genetics, The case of therapeutic cloning Where to go with human genetics? Master Thesis Law & Technology Public defence and graduation 26 th of June 2009 Examination Committee: Prof. mr. dr. J. Somsen and Dr. M.E.A. Goodwin Veronique Christina Leijten ANR: 357778 Preface With this thesis I am finishing my Master in Law & Technology. Graduation on a topic on biotechnology, therapeutic cloning, is considered to be strange for most people: you are a law student, how does this relate to the law? And this is what interests me the most, in this thesis and in my Master programme. In new techniques not everything is regulated as well as in classical subjects such as criminal law. Where new techniques rise, also new problems do. Take for instance the ethical discussion, and possible risks related to this. How we want to regulate these techniques? With, for legal practitioners most obvious, the law, or is it better to let the market regulate? This thesis makes clear that for new techniques the future is uncertain, we do not know where techniques in human genetics will lead to. The technique will always be faster than regulation can follow. Before you will read this thesis, and hopefully get as exited as I am about this topic, I first want to thank everyone who supported me in writing this thesis. Moral support from friends and family. But also the support from my supervisor, Professor Mr. J. Somsen. Han thank you for all the interesting conversations we had about this, and related, topics. It will be exciting what the future will bring, where human genetics go to and what the position of the law will become in this field of biotechnology. Table of Contents Preface . Table of Contents . 1 Chapter 1 Introduction . 3 1.1 Background . 3 1.2 Research question and structure of theses . 4 Chapter 2 Therapeutic Cloning . 6 2.1 DNA . 6 2.2 Stem Cells . 7 2.3 Therapeutic cloning and other possibilities . 8 2.4 Embryos . 10 Chapter 3 Ethics . 12 3.1 Utilitarian perspective . 13 3.2 Dignitarian Perspective . 15 3.3 Human rights perspective . 16 3.4 Drawbacks . 18 3.5 Choise . 19 Chapter 4 Legislation . 22 4.1 History in biotech legislation . 22 4.2 International legislation . 23 4.2.1 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights 1 and Biomedicine . 24 4.2.2 The Additional Protocol concerning Biomedical Research . 25 4.2.3 The Additional Protocol concerning Genetic Testing for Health Purpose . 26 4.2.4 Additional Protocol concerning the Application of Biology and Medicine on the Prohibition of Cloning Human Beings . 27 4.2.5 UNESCO Universal Declaration on the Human Genome and Human Rights . 27 4.3 National legislation . 30 4.3.1 The Dutch Embryo Act (Embryowet) . 30 4.3.2 The Dutch Act Medical Scientific Research with Humans (Wet medisch wetenschappelijk onderzoek met mensen, WMO) 32 4.3.3 The Dutch Act Fetal Tissue (Wet Foetaal Weefsel) . 33 4.4 Overview . 34 Chapter 5 Future . 35 5.1 Neurosciences . 36 5.2 More extreme enhancement . 37 5.3 Immortality . 38 5.4 Prospective . 39 Chapter 6 Conclusion . 41 6.1 Ethics . 41 6.2 Legislation . 42 6.3 Conclusions and recommendations . 43 Reference List . 45 2 1. Introduction 1.1 Background 1953 was a memorable year, human genetics most important discovery was made: the DNA. Our knowledge of this subject has made enormous improvement since then. We can now manipulate this DNA and thus change the hereditary material of plants, animals and even humans. Imagine the possibilities this could lead to. For food we are rather familiar with genetically modified organisms (GMOs). Most people are aware of the fact that production of soybeans, maize and cotton can be genetically modified. In 2002, the global production of genetically modified soybeans was 51 percent. 1 This number implies global acceptance of these techniques for plants. There is a different attitude when it comes to humans and even to animals. This is due mostly to incomprehension of the consequences and ethical objections. Some of these objections are understandable. Take for example pre-implantation genetic diagnosis (PGD) testing, where by taking out one cell of the fertilised egg, and testing this cell, the embryo with the right pairs of genes can be selected. This technique indeed has consequences that lead to further discussion. An example of this is of when, last June, in the Netherlands there was a discussion regarding PGD testing on BRCA-1 and -2 gene, which can cause hereditary breast cancer. 2 As a result of this discussion, in the Netherlands, PGD testing on this type of breast cancer is permitted under specific circumstances. For this thesis, I will discuss one example of the possibilities that come with human genetics: Therapeutic Cloning. This technique can in the future lead to cure diseases like Parkinson’s disease, diabetes, heart diseases, and many more. Currently this technique is in the research stage. Therapeutic cloning is a remarkable development but nevertheless there is room for discussion. There are certain risks which have to be taken into account and there are also moral objections. 1 P. Street, ‘Constructing risks: GMOs biosafety and environmental decision- making’, in: H. Somsen (red.), The regulatory challenge of biotechnology. Human genetics, food and patents , Cornwall: MPG Books 2007, p. 99. 2 Standpunt preïmplantatie genetische diagnostiek Kamerstuk, 26 mei 2008 viewed at <http://www.minvws.nl/kamerstukken/pg/2008/standpunt-preimplantatie-genetische-diagnostiek.asp> 31-10-08. 3 1.2 Research question and structure of thesis Within the confines of this thesis, a number of questions will be answered. Is therapeutic cloning, currently, an international and national accepted technique distinguishable within the current ethical and legal framework? If not, should this in the future be an acceptable technique? Accepting a technique like therapeutic cloning could lead to a whole range of new technological possibilities with human genetics, but where will this end? Will this be a step in human enhancement? To answer these research questions, several elements should be explained further: therapeutic cloning, the ethical- and the legal framework and the definition of human enhancement. In the second chapter I will expose the first element of the research question: what is therapeutic cloning? I will describe a rather technical introduction in therapeutic cloning and other elements of importance to understand this technique, like DNA and stem cell research. In the third chapter, I will define the second element of the research question: the ethical boundaries of therapeutic cloning. In order to introduce my opinion in the ethical discussion around therapeutic cloning I will first explain three competing views, which are derived from the Brownswords bioethical triangle. 3 This triangle contains a utilitarian; a human dignity and a human rights approach. Between these three approaches this whole ethical discussion takes place and even will be predictable. In the fourth chapter I will elaborate on the third element of the research question: the legal framework on therapeutic cloning. It will be an overview of current international and national (Dutch) legislation, in particular the Embryo Act. This legal framework is necessary to see where, nationally and internationally, we draw the line. The line of what we accept in the possibilities of human genetics and what we consider to be crossing this line. This brings us to a fifth chapter were I will depict the future of therapeutic cloning and other futuristic possibilities of human genetics. What will be the direction of these developments and where will it end? I will introduce neurosciences, where in my opinion more extreme possibilities with human genetics are being achieved, real human enhancement, which makes therapeutic cloning not so controversial as it at first seems. 3 R. Brownsword, ‘Ethical pluralism and the regulation of modern biotechnology ’in: F. Francioni (ed.) The Impact of Technologies on Human Rights (Hart, Oxford, 2006) and R. Brownsword, Three Bioethical Approches: a Triangle to be Squared , paper gepresenteerd op de internationale conferentie ’The patentability of biotechnology’ georganiseerd door de Sasakawa Peace Foundation, Tokio, september 2004 (op internet: www.ipgenethics.org/conference/transcript/session3.doc). 4 This will lead to the conclusion where I will give an answer on my research questions whether therapeutic cloning is ethical and legally acceptable or whether these boundaries should be stretched in order to make this an acceptable technique and will argue this by comparing it with real human enhancement. Finally I will conclude with some recommendations in the question where we will end with the possibilities of human genetics.. 5 2. Therapeutic cloning Stem cell research will answer the technical questions of life. The possibilities for the medical industries with stem cell research are promising. Possibilities lead to, for example curing Parkinson’s disease. For the understanding of the problem, where to go with human genetics, the first element of the research question should be explained: what is therapeutic cloning? With this chapter I want to give an insight in the technique of therapeutic cloning. Understanding this technique must include an understanding of (embryonic) stem cell research. As I am not an expert in the field of biology, I will therefore refer to the National Institutes of Health (NIH), which has given me a basic insight into this difficult topic. 4 I will first explain what DNA and stem cells are in order to give examples of the possibilities of stem cell research and eventually end up with the central position of the embryo in this research.
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