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

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

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 31-10-08.

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).

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..

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.

2.1 DNA

The double helix, the twisted ladder formed molecule, is nowadays well known. But what it is, exactly, for most people is an unknown and is not considered important to them. For this thesis a little understanding in this genetic information source surely is necessary. Deoxyribonucleic acid (DNA) is a nucleic acid that contains genetic instructions used in the development and functioning of all known living organisms and some viruses. 5 DNA discovers all (genetic) information about a person, animal or plant. This can be the colour of an organism, but also genetic material which eventually will lead to diseases being traced in this DNA. The double helix contains a genetic code alphabet, which consists of four types of nucleotides (A, T, G and C). These genes will be transcribed into RNA (Ribonucleic acid), which means that a gene is read by a cell and the DNA will be copied into a very similar RNA molecule. After this transcription the RNA will be translated into protein, which means the process of moving information from the language of the DNA alphabet to the language of amino acids. 6 In summary, genes make proteins in cells.

4 National Institutes of Health. “Stem Cell Basics”, http://stemcells.nih.gov/info/basics/basics2.asp (accessed at November 2, 2008). 5 Wikipedia “DNA”, http://en.wikipedia.org/wiki/DNA (accessed at January 20, 2009). 6 Wikipedia “Introduction to genetics”, http://en.wikipedia.org/wiki/Introduction_to_genetics, (accessed at February 26, 2009).

In 1869 the first isolation of DNA was already discovered by Friedrich Miescher, a Swiss biologist. The chemical structure of DNA was still unknown but nevertheless this was a first step in this technology. DNA as we know now was discovered in 1953 by James D. Watson, Francis Crick, Maurice Wilkins and Rosalind Franklin. 7 Their discovery led to being awarded a Nobel prize. It is important to note that DNA is unique per organism, which makes it possible to identify persons with it and therefore popular in criminal investigations. But this DNA is also of great importance in biotechnology and in fact this DNA is the base of further research in human genetics and so in human enhancement.

2.2 Stem cells

(Embryonic) stem cells are a special kind of cells, they contain more genetic information than elsewhere in an organism. Embryonic stem cells differ from normal cells because they have three characteristics. The first of these characteristics is that they are unspecialized, which means that they don’t have any tissue-specific structures that allow it to perform specialised functions. They can give rise to specialised cells, including heart cells, muscle cells, or nerve cells. 8 The latter in fact is already the third characteristic. Besides this, the second characteristic is the ability of stem cells to divide themselves and renew themselves for a long period of time. This differs from normal cells which are not able to replicate themselves. This replicating of stem cells is called proliferating. Proliferating of cells can lead to millions of cells in only a few months. The third characteristic of stem cells is already mentioned: the ability to give rise to specialised cells, which is called differentiation. This third characteristic is still an unknown field for scientists. It is difficult to say which cell by what conditions, inside and outside signals, will be triggered to develop into for example a nerve cell. Here also the difficulties arise. Many questions are still open for scientists, like is this triggering system the same for any living organism? For any stem cell, adult or embryonic stem cells? Scientists are trying to discover these secrets which eventually can lead to major developments in medical science.

7 Wikipedia “DNA”, http://en.wikipedia.org/wiki/DNA (accessed at January 20, 2009). 8 National Institutes of Health. “Stem Cell Basics”, http://stemcells.nih.gov/info/basics/basics2.asp (accessed at November 2, 2008).

I have already mentioned two types of stem cells, embryonic and adult stem cells. An embryonic stem cell is, as the name implies, derived from an embryo. More specific, derived from an embryo created via in vitro fertilisation and donated for research, and not from embryos fertilized in a woman by natural way. I explain this because, in my opinion, is important in the discussion about the use of embryonic stem cells. This will be argued in the next (ethical) chapter but in my opinion the use of laboratory made embryos is a deliberate decision of the ‘parents’ and therefore is an autonomous decision which for me is of importance in the choice of using of embryonic stem cells. The other type of stem cells which I have mentioned are adult stem cells, these, as the name implies, are stem cells derived from adult cells, which means differentiated cells in tissue or organs of a living organism. Adult stem cells can for example be found in fat and in bone marrow. An example of the use of these cells is that currently bone marrow stem cells are used for curing leukaemia. The idea is that the blood stem cells repair the damaged cells of the patient due to their ability to replicate themselves. Of course this is only one possible application. Besides the embryonic and adult stem cells there are more stem cell sources, which for this thesis are not relevant but for a complete view I will shortly mention them. There are also stem cells which are derived from aborted foetuses. Umbilical cord stem cells, which are derived from the umbilical cord blood from newborns. And there are placenta derived stem cells, derived from the placenta and amniotic fluid of newborns. 9

2.3 Therapeutic cloning and other possibilities

Starting from the mentioned leukaemia example, where damaged cells are replaced by new healthy ones, the technique of therapeutic cloning is easier to understand. Although therapeutic cloning is a difficult procedure, and I still am not a biologist, I will try to explain how this technique takes place.

With therapeutic cloning the nucleus of one fertilized egg will be taken out and replaced by the nucleus of another, patient own, adult cell. This can be for example skin tissue. This egg, which now contains patients own material, will reveal into an embryo. Eventually from this embryo, which now contains enough cells with the right DNA, stem cells will be taken out which will

9 D. Kraft. “Everything you wanted to know about stem cells.. But were afraid to ask.” (July 30, 2007), http://www.youtube.com/watch?v=BitVZLX58yg&feature=related (accessed October 23, 2008).

become a specific tissue which can be implanted into a patient. 10 Important to note is that the embryo at this stage is only a clump of cells. At this stage the difference with reproductive cloning can be explained. In therapeutic cloning the cells are kept in Petri dishes, and from there the dividing process is starting. In reproductive cloning, the cells are placed into a surrogate mother, and will develop further as a normal embryo. Back to therapeutic cloning, where I will continue further with the skin tissue example. This newly created tissue will be implanted where it will become the patients own tissue and will repair the damaged tissue. This is due to the previously mentioned special abilities of stem cells. In addition to skin tissue there are many more possibilities. You can think of nerve cells, heart cells and so on. When damaged nerve cells could be repaired, many neurodegenerative diseases like Parkinson’s Disease, and Amyotrophic Lateral Sclerosis (ALS) will possibly be curable in the future. In my opinion these are very promising thoughts.

A promising thought as well is that in many more tissues and organs than thought before, adult stem cells can be found. Scientists are trying to use adult stem cells as well, but unfortunately these adult stem cells have less different types of cells to become: in fact the possibilities are even limited compared to embryonic stem cells which can become every cell, whereby embryonic stem cells still have preference. However, techniques in using other types of stem cells are hopeful for the future. These techniques, in my opinion, certainly have to be developed further but it seems to me like an hidden argument to not use embryos anymore, or in either way less use of it.

It must be noticed that there is a difference in therapeutic cloning, between the research and the clinical practice of it. The first, as the name implies, includes the research on this and subjects related to therapeutic cloning. The clinical practice is the treatment itself in practice, which unfortunately in the Netherlands is currently not available. Further on for this thesis I will refer to the research on therapeutic cloning.

10 Gentechnologie: evolutie op zijn snelst, http://proto.thinkquest.nl/~llb109/klonenth.html (accessed 3 November 2008).

2.4 Embryos

The use of embryos is controversial and is often an objection of many. This ethical discussion will take place in the next chapter but here I want to make clear that in fact in most of the genetic possibilities, the embryo is the central topic. Pre-implantation genetic diagnosis (PGD) testing, embryo selecting before implantation of the fertilized egg, as mentioned in the introduction, is one other possibility of human genetics which causes a lot of criticism because of the use of embryo.

For this embryo discussion it is important to know what an embryo is. In the definition of an embryo a shift has taken place in the last years. Originally an embryo was defined as the result of a fusion of human gametes, the female ovum (egg) and the male sperm, before birth. Later this definition is replaced by the following: an embryo is a cell, or connected cells with the ability to grow into a human. 11 It can be summarized that an embryo is defined as an organism in the earliest stages of its development, the embryogenesis. This stage begins at the moment the zygote takes place, which is the result of fertilization. After this the first cell division takes place until the eighth week of the pregnancy, after this the embryo is called a foetus. 12 After this eighth week the embryo is more developed, but until this moment it is no more than a cluster of cells. In this stage, where the embryo is still a cluster of cells, the research will take place. Cells at this stage do not feel and are in fact a nonentity. Here I also want to point out that the research (on embryos and their stem cells) will not take place on embryos fertilised in the ‘normal’ way but only IVF compounded embryos, which means laboratory made embryos. And due to the characteristic of the embryonic stem cells that they are able to divide and renew itself multiple times, the result is that not many embryos are required. This allows scientists the ability to work several years with the same embryo.

11 E.T.M. Olsthoorn-Heim, “Evaluatie Embryowet”, January 2006. 12 Wikipedia “Embryo”, http://en.wikipedia.org/wiki/Embryo (accessed November 6, 2008).

As seen, therapeutic cloning is a controversial technique with many misconceptions like the status of the embryo and the manner of deriving stem cells. These misconceptions, in my opinion, are purely due to lack of knowledge of the techniques, which leads to the objection of therapeutic cloning and in fact every other use of embryos and their stem cells for research. My goal was to make this difficult topic more comprehensible with this chapter. Above all I hope that this opens peoples views on these important sciences which eventually will lead to major improvement of the quality of life and better methods in health care. With this better knowledge of human genetics it even will be possible to enhance human life.

This is the first time I use the term enhancement. An enhancement is clearly anything that makes a change, a difference for the better. 13 Better in the way of being a superman or woman as Harris sais. Modifications to humans that will be advantageous in terms of powers and capacities, here you can think of walking faster, performing better, better intellect and so forth. 14 Therapeutic cloning is better understanding of human genetics which make it possible to cure people better. I want to make clear that this at itself is no human enhancement, but only considered to be as a therapy. But with this same, or better, knowledge of genetics, human enhancement can be achieved in the future. The question is where will we go with human genetics and what will we accept. Where can we draw a line, ethically and legally?

13 J. Harris, Enhancing evolution (Princeton University Press, 2007) p.36. 14 ibid.

3. Ethics

As described in the previous chapter, therapeutic cloning is a controversial but progressive technique with significant possibilities for the future. With this technique will come the inevitability of misconceptions of individuals who are not experts on this topic. Misconceptions like the deriving of the embryos, which is not by normal sexual reproduction, but laboratory made. The age of the embryo used for stem cells, which is the stage when the embryo is only a little clump of cells, nothing more, no life, no feelings. And the misconception of the ability to divide and renew themselves, the proliferation. Due to this characteristic of stem cells, one embryo can be used for a long period, so ‘killing’ repeatedly new embryos for deriving embryonic stem cells is not necessary. My aim was by giving an introduction to the biology in the previous chapter, I took away these misconceptions to make it possible to come to a rich, and honest discussion regarding therapeutic cloning and its use of embryonic stem cells which come with this technique. In this chapter I want to go into the second element of my research questions: the ethical boundaries which come with therapeutic cloning. Ethical views are powerful discussion material, as well for this embryonic stem cell research which comes with therapeutic cloning. The discussion has three different views as a starting point. There are three competing ethics which together form the Brownswords bio-ethical triangle. 15 The utilitarian, the dignitarian and the human rights perspective. Now I call this the bio-ethical triangle, but in fact these perspectives come with every technique, whether it is biotechnology, nanotechnology or another (controversial) technique. In this chapter I want to point out a description of these three perspectives. Thereafter I will also mention the drawbacks of these in view of my own perspective.

15 R. Brownsword, Rights, Regulation, and the Technical Revolution , (Oxford University Press, 2008) p. 35.

3.1 Utilitarian perspective

The first perspective of the Brownsword bio-ethical triangle is the utilitarian perspective. Founders of this utilitarian perspective are Jeremy Bentham (1789), John Stuart Mill (1861) and Henry Sidgwick (1907). 16 For the utilitarian, of course, the utility is of importance. Utility is defined as being pleasure, happiness, satisfaction, benefits and other positive effects. The sum of these positive aspects should be balanced with the sum of the negative aspects, the disutilities like pain and suffering, frustration, costs and other negative effects. Maximization of the utility and minimization of the disutility’s are the goals of this utilitarianism. 17 In fact, this utilitarian perspective is an economic approach. A cost and benefit assessment. Subjects of new development or technologies should always undertake this assessment to find out the moral acceptability and the rightness of it. If the balance indicates more harm instead of benefits, the development (or the technology) should not be accepted as morally right, and the other way around the development can be accepted. After this assessment regulation will follow. The regulation can differ from, in my perspective as a law student the most obvious, the law, but also by code, architecture.

This cost and benefit assessment could also be held for the technology therapeutic cloning. At first the major benefit of therapeutic cloning is of course improvement of quality of life, even extending life in case of deadly diseases. When we, in the future, are able to cure terrible, deadly diseases and so improve human life will be a great improvement! Curable pain or even no pain when it comes to diseases. No more discomfort of diseases like diabetes. Technical questions of life, such as how will the human body works exactly in for example case of cancer, can be answered in the future. On the other hand, there are also people who fear for the enhanced future and stand for no further development in human genetics. As an argument can be given that we do not know where these techniques concerning genetics will lead to. Extreme thoughts can be given here. For example you can think better understanding of human genetics is an innocent medical improvement, but in fact this can lead to a new form of discrimination: genetic discrimination. When genetic information about a person is known by insurance companies or employers, there

16 W. Sinnott-Armstrong, “Consequentialism”, Stanford Encyclopedia of Philosophy (2006) http://plato.stanford.edu/entries/consequentialism/ (accessed at November 26, 2008). 17 R. Brownsword, Rights, Regulation, and the Technical Revolution , (Oxford University Press, 2008) p. 37.

is a certain risk that this information will be misused.18 People could be excluded from the insurance company or could get fired. Is this acceptable? Or should the right for everyone to insure themselves overrule? At the moment general rule is: ”any form of discrimination against a person on ground of his or her genetic heritage is prohibited” according to Article 11 of the Convention on Human Rights and Biomedicine. 19 And the Netherland have a code for insurance companies concerning the use of genetic information. 20 But, fact is that we do not know what exactly will happen in the future and the challenge is there to be on time in regulating this unknown future. In time regulating is difficult due to the law following behind the technique, so a clear awareness of what is happening in those laboratories is necessary. In my opinion we should not be led by fear in decide what is acceptable in human genetics. A major point of discussion is the use of human embryonic stem cells. With rat embryonic stem cells we agree, but we are at the stage that not everything can be tested on rats anymore. For most people the step to human embryonic stem cells is not acceptable, most of the arguments here are based upon religious grounds. But there are also arguments, as said earlier, based on misconceptions about the technique. Knowledge of the unique characteristics of embryonic stem cells, like the proliferation, the ability of dividing and renewing themselves again for a long period, and the differentiation, the ability of them to become any cell type or tissue, should take these misconceptions away. Fact is that there is, yet, no alternative for embryonic stem cells because at the moment derived adult stem cells have fewer possibilities to develop. Although recent research is progressive, in the future it may be possible to re-program adult stem cells into embryonic stem cells. 21 This will make parts of this ethical discussion redundant. The outcome of a cost-benefit analysis can differ per discussion, based on given arguments. In my opinion the balance indicates more benefits which results in acceptance of a technique like therapeutic cloning. But as said this can differ per discussion and thus this is no final answer on the question whether therapeutic cloning should be allowed.

18 B van Beers, ‘De humaniteit van humane biotechnologie’, in: Humane Biotechnologie en Recht , (Kluwer Deventer, 2009) p. 118. 19 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 and Biomedicine, Oviedo, April 4, 1997. Available at: http://conventions.coe.int/treaty/en/treaties/html/164.htm (accessed at June 23, 2009). 20 See http://www.zn.nl/leeszaal/zn_uitgaven/znuitgaven/gedragscode_van_de_zorgverzekeraar.asp (accessed at June 23, 2009). 21 “Stem cell breakthrough: safe and ethical”, Bioedge , (March 6, 2009).

3.2 Dignitarian perspective

The second perspective of Brownswords bio-ethical triangle is the human dignity. 22 This perspective is merely followed by religious people. Kant can also be seen in this approach. 23 His ideas are based on autonomy and dignity. In this dignitarian approach every practice, if it is therapeutic cloning, stem cell research or ICT, will be compared to the human dignity, and will condemn this or not. For this thesis is the moral status of the embryo of importance, because in fact this, for the dignitarian people, is the major problem in therapeutic cloning: hassling with an embryo. This embryo is life: living from day one of its embryonic development, thus right after fertilization. Dignitarians compare this human embryo with a machine, which is able to function after it is build, an embryo has to develop itself from a single cell to a human being. 24 This means that because of it’s continuously development, the embryo in its early days already is life. And in their opinion this early stage of life should be respected and treated the same as a living human, and so not to be “killed”. 25 In addition to this argument, the dignitarian are against the use of humans to achieve a higher goal, in this case curing diseases with the use of therapeutic cloning. Human embryos, in their opinion, should not be used to improve ourselves.

And this is the point where the road ends. In fact there is no room for further discussion in the dignitarian approach where simply it can be said that life should not be ended, not even in the early stages of development. And so embryonic stem cell research, and therapeutic cloning with the use of embryonic stem cells, is not allowed in their perspective. In my opinion this dignitarian approach is a narrow perspective.

Respect is a key word in the dignitarian approach. But in fact this is a bit contrary. Because of this research major breakthroughs will be made in the future. Complex and problematic diseases may possibly will be solved. This is great for patients suffering these, and so improves the quality of human lives. But these dignitarian block this development by condemning any hassling with embryos. Where is the respect for your neighbour when you only see your own view?

22 R. Brownsword, Rights, Regulation, and the Technical Revolution , (Oxford University Press, 2008) p. 39. 23 M. Schönfeld, “Kant’s Philosophical Development”, Stanford Encyclopedia of Philosophy (2007) http://plato.stanford.edu/entries/kant-development/ (accessed March 21, 2009). 24 D. Jefferson, “The moral status of the embryonic human: religious perspectives”, Ethics and Medicine (2006) p.22(1), 9-21. 25 “You shall not kill”, Exodus 20:13, available at: http://www.artbible.info/bible/exodus/20.html (accessed at June 24, 2009).

Do not misunderstand me when I condemn this dignitarian approach. I respect every person’s own opinion and will be the last to force mine on everyone. But I want to make clear that there is a need for medical development. These days people get older and so more diseases will show up. Funny here is the reason peoples lives are longer: thanks to development. We don’t have to hunt and search for food. We have doctors and dentists. Should I mention more? These developments are probably criticised at the beginning as well, but finally they were accepted and now even are common. This, in my opinion, will probably will be the same for therapeutic cloning in the future.

A next step is necessary to combat the troubles nowadays: cancer, diabetes, Parkinson’s disease and so on. Solutions to cure these diseases should be found and therefore embryonic stem cell research is necessary. As long as the leading parties of a country, like for example the Netherlands, base their legislation on their religious grounds we will not get any further. In my opinion legislation should not be based on religious grounds. Certainly not when you are aware of the fact that the percentage of religious people in the Netherlands is declining and the need for solutions is rising. 26

3.3 Human rights perspective

The third perspective in the bio-ethical triangle is the human rights approach. These higher rights, such as privacy and physical integrity can be found in the European Convention on Human Rights (ECHR). Every person is entitled to these rights, although foetuses, embryos till the age of six months, don’t have these rights according to the European Court of Human Rights which decided so in 2005. 27 In fact with this point of view the dignitarian approach already is rebutted. An embryo has human rights, and so the right to live, at the age of six months. Not earlier, so embryonic stem cell research, which comes with therapeutic cloning, should be allowed. The United Nations Educational, Scientific, and Cultural Organisation (UNESCO) made the first bio-ethical fundamentals. The idea is that when use of the technology leads to any infringement of a human, higher right, this would lead to non acceptance of the technology. This also comes the other way around, when there is no infringement the technology should be

26 See CBS statistics for religion at http://statline.cbs.nl/StatWeb/publication/?VW=T&DM=SLNL&PA=37944&D1=a&HD=081206- 1608&HDR=T&STB=G1 (accessed at December 6, 2008). 27 (2005) 40 EHRR 12.

accepted. Of importance is the exception which is the personal autonomy. This makes people able to decide their own legal status, which can differ from the human rights. 28

Let me try to answer the question whether stem cell research, and so therapeutic cloning, can be an accepted technology seen from the human rights perspective. Given the fact that the ECHR decided embryos in the early days does not have any human rights, there can’t be any infringement of human rights. So far can’t be seen any problem. The autonomy is a different perspective. There can be different views here. Fact is that this is a personal choice. It is up to the couples (or women) to decide if they want to donate (fertilized) eggs for research. Often this takes place after an IVF treatment were more fertilized eggs are created than necessary and the remaining eggs then can be donated for research. If a person decides to (not) donate should that choice be respected. Also the, in the Netherlands at the moment not available, clinical practice of therapeutic cloning, should be an autonomous decision of the patient to have a treatment like this. Stem cell research, and so therapeutic cloning can be an accepted technology seen from this perspective.

In my opinion the human rights perspective is the best perspective. Universal human rights are the same for every person. And these rights are universally accepted and respected because of the ECHR. There can be said that these higher rights are fundamental. Because they are fundamental, universally accepted and the same for everyone, it is fair to use these rights as a standard for acceptance of new technologies. If there still are any personal objections, there is still the option to condemn this technology on the ground of autonomy. This implies that autonomy, and so the personal view, has the last word above national, legitimate, accepted technologies. This autonomy is in my opinion is of great importance and should always be respected. If rejection is based on religion, science or just an opinion should not matter. This with the exception that this autonomous decision will not influence other persons. In the case of stem cell research, not donating eggs will not influence others in that way that this will be made impossible for everyone.

28 H. Somsen, Regulering van humane genetica in het neo-eugenetische tijdperk (Nijmegen, Wolf Legal Publishers 2006) p.30.

3.4 Drawbacks

We have seen three different approaches of bio-ethical problems. The utilitarian, the dignitarian and the human rights approach. Drawbacks can be made for every of these three approaches. The utilitarian, at first sight, seems a reasonable and fair approach. All opinions, pro or contra, will be weighed carefully. But here is in my opinion a problem, all opinions count. Every opinion, useful or not, can be put into the battle of acceptance. Unfortunately there are too many opinions based on misconceptions. In the case of the use of human embryonic stem cells it is clear that there are, yet, no alternatives for these cells. Besides this there is a need for solutions for common diseases like Parkinson’s. These diseases are arisen because of the better life circumstances we know nowadays where our lives are extended. It is time that diseases should be battled. The dignitarian approach should in my opinion be respected but not used for legislation. This is because this is a narrow perspective. Dignitarian do not allow any hassling with human embryonic stem cells. There is no room for discussion in their perspective of life. In agree that these cells in the first days are already living objects. We need these “living objects” for scientific research. But the fact that these embryos do not feel anything and in fact are nothing more than a cluster of cells, is also confirmed by the ECHR. An embryo under the age of six months has no human rights. No legal status, which will lead the choice of using it by the parents, or in either way the mother. Dignitarian would still reject any use of it. But then it is an autonomous decision, like the decision of having an abortion is. This autonomous decision should be respected as long as this will not influence others. With this dignitarian “life” argument we come to the killing. As said destroying an embryo, even for medical (research) purposes, is in their view killing. But the loss of embryos in normal sexual reproduction is high, very high. 80% of the embryos will result in a miscarriage. 29 Miscarriages are caused by genetic problems or chromosome abnormalities. 30 This means that Mother Nature is “killing” all by herself, for genetic reasons same as scientist do. I do not see that much difference.

When legislation is based on religious grounds that condemn human embryonic stem cell research it will influence the whole society. But in a way which nowadays, because of decreasing numbers of religious people, in my opinion is not desirable anymore. This is due to the growing desire to enhance ourselves in a way of improving our health.

29 J. Harris, Enhancing evolution (Princeton University Press, 2007) p.172. 30 Wikipedia “Miscarriage”, http://en.wikipedia.org/wiki/Miscarriage, (accessed at March 20, 2009).

Following on the autonomous decision which should be respected: the human rights approach. This third approach is, as said earlier, in my opinion the best approach. Universally accepted higher norms are a good standard for measuring acceptability. Because they are accepted by everyone as important rights for every human and thus are legitimate. Technologies, should be measured with these standards and thereafter concluded to be acceptable or not. The legitimate process of acceptability can, in case of autonomous personal objections, still lead to condemning the technology by persons. As said earlier this autonomy, for me, is one of the greater, and most important goods which should be respected as long as there is no influence on others. But this human rights perspective has also some drawbacks. It can be said that these universal rights are not that universal as I will proclaim, because not every, even civilised, country accepts these rights. Think of the United States of America, is their opinion wrong? Fortunately president Obama of the United States recently made embryonic stem cell research possible again. 31 This research was forbidden under the Bush administration because of religious grounds. You can see the dignitarian view was leading in the US for a long time. Now, with this change, new breakthroughs in the stem cell research hopefully will be close.

3.5 Choice

It might be clear already that I support therapeutic cloning. The fact I am non religious might help in my position in this ethical discussion. This makes it easier for me in the discussion about the use of these embryos. Because of my non religious background I do not consider it life but only a clump of cells in the earliest stage of its embryonic development. Whether these embryos are especially made for research or leftovers from IVF treatments will not make any difference to me. I think to use these leftovers instead of destroying them is more useful for science in effectiveness, as well in costs as in time perspective. Although I am positive about therapeutic cloning this will not include my acceptance of every hassling with embryos. Embryonic research for medical purposes is in my opinion acceptable. But, in case of in the introduction mentioned PGD testing, in my opinion there are boundaries in this research. As legislation is now in the Netherlands, selection of embryos is only permitted in case of a few hereditary and deadly diseases such as breast cancer (the BRCA-1 and

31 See CBS News “Obama Ends Stem Cell Research Ban” at: http://www.cbsnews.com/stories/2009/03/09/politics/100days/domesticissues/main4853385.shtml (accessed at March 13, 2009).

the BRCA-2 genes). In my opinion, and fortunately the opinion of the Dutch Minister of Health Welfare and Sports, this list of limited cases can be extended with other hereditary and deadly diseases. 32 Theoretically it is possible to select other genes as well. Here you can think of the colour of the eyes, or the hair of the child. But in the future it maybe possible to select the genes which are related to musicality, choosing to let your child be the next Wibi Surjadi. 33 Or to select genes which are related to an athletic body to become a good sportsmen. Here is my red line in where to go with human genetics, these kind of purposes should not be accepted in my view.

It is my autonomous decision to draw my personal line in acceptance of possibilities with human genetics at this level. This is the autonomy I have stated before. In my opinion this autonomy, together with a utilitarian view is considered to be leading in acceptance of a technique. For a person, the benefits of the treatment, technique or other should prevail above the disadvantages. By being autonomous the person thereafter should also be possible to have this treatment, use this technique or other. With this autonomy the line of acceptance can differ per person. What I see as an inconvenience such as hay fever, and consider not to be a priority for me to cure, can be a priority for another person. Leading is the opinion of the person it is concerning. If this person is convinced by the fact the improvement, treatment or other will be good for him, this should be accepted. Although this could lead to additional unexpected possibilities, as long as this autonomous decision will not influence others, this choice should be respected. By stating that as long as a decision to have a treatment is made after a carefully balanced weight between utilities and disutility’s and out of autonomy, I will create an enormous space for a diversity of treatments. This could be a risk because different people have different needs. You could imagine treatments to cure all kind of diseases (which I can imagine to be desirable to cure) but also treatments for better looks and other. All is possible when you allow people to have autonomous decisions in their choice of treatments. Therefore it is also necessary to limit extreme possibilities, like now reproductive cloning is prohibited. This should be universally accepted to stop people “shopping” in other countries where a treatment is permitted.

32 Standpunt preïmplantatie genetische diagnostiek Kamerstuk, May 26, 2008 at: (accessed at March 17 2009). 33 Wibi Surjadi is a famous Dutch classical pianist.

Although with this I have created a clear ethical line in the acceptability of human genetics. There sometimes will exist contrary feelings. You can have thought well about a topic, and come to the conclusion of acceptability, but at the same time your heart sais no. Also in these situations you should be clear, and remain rational in your decision, although this can be very difficult.

4. Legislation

In search for the line in where to go with human genetics, I have explained a case study, therapeutic cloning. As described in the previous chapters there are some technical boundaries in this technique which makes it unknown whether this could ever be possible. Besides this, I have shown there are ethical boundaries coming with this technique as well. As a law student, the most obvious boundary of human behaviour is legislation and that is what this chapter is about. Main goals of the law are effectiveness and legitimacy. With effectiveness you can think of sufficient risks covered, or not. But also in possibilities created by this law, what is allowed and what is not. In either way is effectiveness the most effective way, in costs and effort, to achieve the goal of the specific law. Legitimacy is more difficult to define. With this is meant achievement of urgent public interests which justifies regulation. The regulation that will follow on this urgent situation, should therefore be created by a legitimate institution. 34

In this chapter I first want to point out a historical overview in the biotech legislation, which also includes GMO regulation, in order to discuss current international and national (Dutch) legislation concerning therapeutic cloning in the light of its effectiveness and legitimateness. For this thesis it is impossible to discuss all legislation, simply because there is too many. So I will restrict myself to the, in my opinion, most important international and national legislation. After this, for a comparison, I want to point out the British legislation. I have chosen the British because they are very progressive in their research and legislation concerning therapeutic cloning.

4.1 History in biotech legislation

History of environmental law and modern biotechnology goes back to the 70’s, where scientists see possibilities but also warned for the dangers of biotechnology. This need for legislation in biotechnology led to a major political discussion. 35 In the Netherlands the Royal Dutch Academy of Sciences set up a commission for risk assessment in genetic manipulation. After this first commission other, DNA specific commissions, followed. Because of the risks coming with the

34 J. Somsen, ‘Humane biotechnologie en recht: regulering, zelfbeschikking en waardigheid’, in: Humane Biotechnologie en Recht , (Kluwer Deventer, 2009) p. 11. 35 S. Bostyn, Moderne biotechnologie en recht , (Kluwer Deventer, 2001) p.18.

research on these topics, there was a need for governmental verification. In 1984 the first official governmental position was taken. This position was that there was no need for separate legislation so the government implemented regulatory aspects in existing legislation. 36 In 1990, on EU level, the need for regulation is expressed, two important EU Directives were introduced that same year: Directive 90/220/EEC 37 (Deliberate Release Directive) and Directive 90/219/EEC. 38 Directive 90/220/EEC contains regulation for the protection of health and environment by constricting the use of GMO’s. Directive 90/220/EEC intends Member States to implement measures to prevent for negative effects of introduction or providing of GMO’s for human health and environment. These first steps eventually led to a broad range of legislation. In the Netherlands this same year was introduced the first regulation on this topic as well, the Act genetically modified organisms (GMO’s) and environmental danger materials. 39 This Act regulates introduction of GMO’s in the environment, here you can think of experimental genetically modified plants like potatoes. This was only the beginning in regulating biotechnology.

4.2 International Legislation

International legislation forms the base in our national, Dutch, legislation. With the 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 and Biomedicine, the Council of Europe created an appropriate base in Biotech regulation. UNESCO’s Universal Declaration on the Human Genome and Human Rights is its worldwide variant. In this chapter I will restrict myself to these two and their Additional Protocols concerning Biomedical Research, Genetic Testing for Health Purposes and the Prohibition of Human Cloning. With this there should be a rather clear view in the international legislation concerning therapeutic cloning and embryonic stem cell research.

36 Regulatory aspects were implemented in the Dutch Hinderwet and in the Dutch Arbeidsomstandighedenwet/Veiligheidswet, this was seen as sufficient. S. Bostyn, Moderne biotechnologie en recht , (Kluwer Deventer, 2001) p.21. 37 Directive 90/220/EEC available at: http://www.biosafety.be/GB/Dir.Eur.GB/Del.Rel./90.220/TC.html, accessed at March 29, 2009. 38 Directive 90/219/EEC available at: http://www.biosafety.be/GB/Dir.Eur.GB/Cont.Use/90.219/TC.html, accessed at March 29, 2009. 39 Besluit genetisch gemodificeerde organismen Wet milieugevaarlijke stoffen, Stb. 1990, 53.

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 and Biomedicine 40

The 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 and Biomedicine (hereinafter referred as the Convention) its main aim is protection of the dignity and identity of all human beings and will guarantee everyone respect for the integrity and other rights and fundamental freedoms with regard to the application of biology and medicine. 41 Of importance is that the interest and welfare of the human being will prevail over the sole of interest of society or science. 42 Intervention in the health field may only be carried out after all relevant information, which also includes possible risks and benefits, is be presented to the person concerned so that an informed decision can be made prior to him being asked to give his explicit consent. 43 This is called a prior informed consent. Also it is possible for the person to withdraw this consent at any time. Also consent in case of persons who are not able to give their consent, have a mental disorder or in emergency situations, is defined in the Convention. 44 The convention has a chapter concerning the Human Genome, where is defined that discrimination on genetic heritage is prohibited. 45 Predictive genetic tests are only allowed in case of health purposes or for research likely to that health purpose. Interventions on the human genome are only permitted for preventive, diagnostic or therapeutic purposes, under the condition that no modification will take place in the genome. Important is Article 14 which explicitly prohibits gender selection, except when there is a serious hereditary gender-related disease that can be avoided. Another chapter is describing organ and tissue removing from living donors for transplantation purposes. 46 This is only allowed in case of therapeutic benefit and when there is no alternative method of comparable effectiveness.

40 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 and Biomedicine, Oviedo, April 4, 1997. Available at: http://conventions.coe.int/treaty/en/treaties/html/164.htm (accessed at April 13, 2009). 41 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 and Biomedicine, Art. 1. 42 ibid, Art. 2. 43 ibid, Art. 5. 44 ibid, Art. 6, 7, 8 and 9. 45 ibid, Chapter IV. 46 ibid, Chapter VI.

The convention led to a broad framework. Additional Protocols on specific topics were added for specification. I will describe these Additional Protocols shortly.

4.2.2 The Additional Protocol concerning Biomedical Research 47

Biomedical research is a powerful tool to improve human health. Freedom of research in the biomedical field is of importance because it brings benefits for the health care field. But it is necessary to protect persons participating in this research to risks. 48 With the Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Biomedical Research (hereinafter referred as the Protocol) the Council of Europe wants to protect these persons. The main aims of this Protocol are similar to the original Convention, although it is specified in protection in research involving interventions on human beings in the field of biomedicine. 49 The Protocol sees on foetuses and embryos in vivo , which means the living, and explicitly not on embryos in vitro .50 Added in this protocol is the independent examination of an ethics committee. 51 They examine the acceptability of the research project on basis of dignity, rights, safety and well-being of the research participants. Finally of importance according to this protocol is that during research all reasonable measures shall be taken to ensure safety and minimize risk and burden for the research participants, which means that research should only be carried out under supervision of a clinical professional. 52

47 The Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Biomedical Research, Strasbourg January 25, 2005. Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm (accessed at April 11, 2009). 48 Secretary General of the Council of Europe, Explanatory Report of the Additional Protocol . Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm (accessed at April 13, 2009). 49 The Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Biomedical Research, Art. 1. 50 ibid, Art. 2. 51 ibid, Art. 9. 52 ibid, Art. 21.

4.2.3 The Additional Protocol concerning Genetic Testing for Health Purpose 53

Because there was made remarkable progress in the field of human health thanks to research in biology and medicine, genetics are a promising field. Identification of genetic characteristics responsible for diseases, or genes involved in development of these diseases are advances which come with the better understanding of the human genome. You can imagine the benefits in early diagnosis with this knowledge. With the Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (hereinafter referred as the Protocol) the Council of Europe wants, according to the principles embodied in the Convention, to protect people in the specific field of genetic testing for health purposes. This is because the technique is difficult to understand for the people concerned and to occur in commercial practice outside the health field. 54 Also the main aims here are similar to the Conventions but specifically on genetic testing for health purposes. 55 Also the procedure in giving consent, providing information and the examination of an ethical committee are the same. 56 Further this Protocol is focussed on genetic testing for health purposes and does not concern genetic testing for research purposes and also not on genetic testing on foetuses and embryos. 57 Finally, this Protocol provides in certain conditions in the quality of genetic research, in the tests itself, the laboratories and of the persons providing the genetic services. 58

53 The Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg November 27, 2008. Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/203.htm (accessed at April 12, 2009). 54 Secretary General of the Council of Europe, Explanatory Report of the Additional Protocol . Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/203.htm (accessed at April 13, 2009). 55 The Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Art. 1. 56 ibid, Art. 8, 9 and 19. 57 ibid, Art. 2. 58 ibid, Art. 5.

4.2.4 Additional Protocol concerning the Application of Biology and Medicine on the Prohibition of Cloning Human Beings 59

Cloning is more and more a discussion issue. The technique of cloning cells and tissue is an acceptable technique but there is still a discussion around the ethical acceptability of embryonic cells. 60 In this Additional Protocol concerning the Application of Biology and Medicine on the Prohibition of Cloning Human Beings (hereinafter referred as the Protocol) the prohibition of cloning human beings is central. Article 1 of this Protocol clearly states that any intervention seeking to create a human being genetically identical to another human being, whether living or dead is prohibited. With this “human being” is meant as a genetically identical same nuclear gene set. This means reproductive and therapeutic cloning are not allowed. But the Protocol is not ratified by all countries.

Concluded can be that according to the Convention and its Additional Protocols, research on behalf of biomedicine on humans and genetic testing for health purposes is allowed, but only under strict conditions. The main guideline is respect to human’s rights and their dignity. As seen the Council admitted that freedom of research is of importance and, in combination with the respect of human rights and human dignity, there is room for further research on genetics and biomedicine. But in the protocol concerning cloning human beings is explicit states that cloning is prohibited. Is this a binding no on therapeutic cloning? No, states are not obliged to ratify these protocols. Which leaves the choice to the states itself. For your information, the Netherlands signed the Convention in 1997, but until now it is still not ratified. 61

4.2.5 UNESCO Universal Declaration on the Human Genome and Human Rights

Another important instrument in international legislation is the United Nations Educational, Scientific, and Cultural Organisation (hereinafter referred as UNESCO). The UNESCO Universal Declaration on the Human Genome and Human Rights (hereinafter referred as the

59 Additional Protocol to the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine on the Prohibition of Cloning Human Beings, Paris, January 12, 1998. Available at: http://conventions.coe.int/Treaty/EN/Treaties/Html/168.htm (accessed at April 16, 2009). 60 Secretary General of the Council of Europe, Explanatory Report of the Additional Protocol . Available at: http://conventions.coe.int/Treaty/EN/Reports/Html/168.htm (accessed at April 16,2009). 61 For an overview of countries which, and which not signed the Convention see: http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=8&DF=5/19/2009&CL=ENG (accessed at May 19, 2009).

Declaration) is an international instrument for protection of the human genome. 62 This Declaration provides to the rights of persons. So research, treatment or diagnosis affecting an individual’s genome should always undergo an assessment of the potential risks or benefits which come with this research, treatment or diagnosis and should there always be consent. 63 Concerning the research on the human genome the Declaration states that this should not prevail over the respect for the human rights, fundamental freedoms and human dignity of individual people or groups. 64 Following on this, Article 11 of the Declaration states clearly that reproductive cloning is not permitted because this is contrary to human dignity. However, there is a certain freedom of research, as a part of freedom of speech, which is necessary for the progress of knowledge. 65 Further on, States should take appropriate steps and measures, according to the principles of the Declaration, in regulating, and promoting this regulation, the research on the human genome. 66 According to the Declaration, co-operation between western and developing countries should be encouraged by States, for example by free exchange of scientific knowledge and information in these fields. 67

This UNESCO Declaration is a rather broad instruction for States to regulate protection of the human genome in research. Only when human dignity is in danger, research is not allowed. Specifically the Declaration mentions reproductive cloning, the prohibition of this technique for which I agree upon. But is therapeutic cloning allowed according to this act? Is therapeutic cloning contrary to human dignity? In my opinion it is not. Maybe because of my non religious background, but I don not see a danger to human dignity when it comes to research with non viable, laboratory made embryos. If diseases can be cured with the use of these embryos in combination with a patient’s own cells, this is great.

By reviewing these two international instruments, the Convention and the UNESCO Declaration, two things stand out: the combined regulation for therapeutic cloning and reproductive cloning and the central position of the human dignity criteria.

62 UNESCO Universal Declaration on the Human Genome and Human Rights, November 11, 1997. Available at: http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html (accessed at April 12, 2009). 63 UNESCO Universal Declaration on the Human Genome and Human Rights, Art. 5. 64 ibid, Art. 10. 65 ibid, Art. 12. 66 ibid, Art. 14, 15, 16 and 22. 67 ibid, Art 19.

The first point which stands out is the combined regulation for therapeutic- as well as reproductive cloning. These, in my opinion, are very different subjects and should not be combined in regulation but treated separately. This is because we all agree upon the fact that human reproductive cloning is not acceptable, but there are still doubts about the acceptability of therapeutic cloning. The core basis of these techniques are quite similar, but they both achieve different goals. The combined regulation makes it difficult to understand what is, and what is not prohibited. Besides this missing distinction in the regulation there is the concept of human dignity which has a central position in both instruments. But what is this, at first sight, vague criteria of human dignity? I will go back to the ethical part of the discussion were different opinions about this concept exist. At first there is an extrinsic view, which means attributed to them by others. 68 This view can be related to the dignitarian, a (religious) concept of human dignity which can be entitled as a more restricted view. Humans should not be used to achieve a higher goal. In other words humans should not be used for further human enhancement. By stating human, this refers to embryonic stem cells, which in their view is new life. But human dignity can also be seen in the light of autonomy. This is called the intrinsic view of dignity, which exists simply because they are human. 69 So human dignity exists as long as there is autonomy of the person concerning. This person can decide for himself whether he accepts a technology. This opinion can differ per person. Here I can conclude that effectiveness of this regulation, the prohibition of cloning, is none. Both points, the combined regulation and the vague human dignity criteria, make it difficult to understand what is, and what is not prohibited. In fact it is up to the countries itself to interpretate these, which makes the regulation in my opinion ineffective. This leads to a range of different grades of acceptability of therapeutic cloning. What leads to the question: Is all this regulation still universal? And where will this lead to? I can imagine when research eventually will become clinical practice, patients will go shopping in other countries where therapeutic cloning is allowed when they are suffering from a disease which is curable by this method. This is a situation we should want to prevent in my opinion.

68 M. Somerville, The Ethical Canary, Science, Society and the Human Spirit , (Viking/Penguin Canada, Toronto, 2000) p.77. 69 ibid.

4.3 National legislation

The Dutch Constitution is of importance for all Dutch legislation, including Dutch health rights. Article 22 of the Constitution states “the authorities shall take steps to promote the health of the population”. This, and of course international legislation, form the basis of the Dutch health legislation. In this chapter I will discuss the Dutch Embryo Act, the Dutch Act Medical Scientific Research with Humans, the Dutch Act Fetal Tissue and the Dutch Act Safety and Quality Body material. I will mention the most important parts of these and will discuss them.

4.3.1 The Dutch Embryo Act (Embryowet)

The first legal boundary of therapeutic cloning is the Embryo Act. 70 This Act regulates circumstances and requirements in which the use of embryos and human gametes is permitted. The Act gives definitions of embryos and gametes. An embryo is a cell, or connected cells, with the ability to grow into a human. Gametes are the human male sperm and female ovum. 71 One of the main topics of this Act are forbidden actions such as human cloning, the choice of the gender of the child and the combination of human and animal cells. The Act states that embryos or human gametes should be donated only by adults, the consent will be given in written form where the exact intention and purpose of the use will be agreed upon. 72 The prior informed consent which already explained in the international legislation is also obliged in the Netherlands. The donation of the embryos can be done after an IVF treatment where gametes and embryos no longer will be used for pregnancy. These gametes or embryos then can be used for another pregnancy (donation) or for scientific purposes. 73 For the purpose of scientific research there are certain conditions which should be fulfilled. At first the expected new knowledge should be of importance for the art of medicine. Also there should not be an alternative research method to achieve the same result. And an ethical commission (CCMO, Central Commission on Human Research) should give permission for the research. 74

70 Embryowet, Stb 2002, 338. 71 Embryowet, Art 1. 72 ibid, Art. 5. 73 ibid, Art 8. 74 ibid, Art 10.

Specific laboratory made embryos are now forbidden because of the respect for human life. 75 Here I can refer to the previous chapter were I point out the dignitarian/religious grounds of the Dutch legislation on this subject. In the future this statement of life might change when there are possibilities to cure a the disease like Parkinson’s. Choice of gender of the child is only permitted in situations where there is a risk for serious hereditary gender specific diseases. 76 In my opinion this should remain the same. As stated in the previous chapter, allowing the choice of gender for other than medical reasons will have unwanted results. In the evaluation of the Embryo Act is mentioned a situation of haemophilia, hereditary but not dangerous for females. The parents want a boy because then the disease will be banned. Here in fact there is no medical reason for selecting gender, because for a future daughter the disease will not be dangerous, she will only be a carrier of the genes. Here it can be doubted about the motive of choice of gender but in different advises it is decided that in these kinds of situations the choice of the parents should be respected. Questions here are: is this the intention of the Embryo Act, and what is the width of this Act? Should there not be more situations where gender selection is allowed? 77 In my opinion only for medical reasons, which includes situations like these, are allowed in selecting. There is a need for re-defining this article, more broad but specific, because current situation is too vague. Of importance is also the definition of an embryo. 78 This definition, a cell or connected cells with the ability to grow into a human, leads to the question of artificial gametes are also protected by this Act. The definition excludes not viable embryo’s which just are applicable for research. And if an embryo is made from adult cells, are they protected? 79 These questions imply that a new definition of an embryo is necessary. Like techniques are progressive, legislation should be progressive as well. My conclusion of the Embryo Act is that it is according to international legislation as the Convention and its additional Protocols considering elements like prior informed consent and the ethical commission which should give permission for the research. Research on embryos or gametes should be protected well, but in these few years of existence basic elements of this Act need to be changed to still be accurate as also stated in the evaluation of the Embryo Act. 80 So is there a need to redefine the definition of an embryo when we, in the future will, allow therapeutic

75 Publications around the Embryo Act of the Dutch Ministry of Health Welfare and Sports available at: http://www.minvws.nl/folders/ibe/hoofdlijnen_van_de_embryowet.asp, accessed at March 29, 2009. 76 Embryowet, Art. 26. 77 E. Olsthoorn-Heim, Evaluatie Embryowet , (The Hague, June 2006) p 63. 78 ibid. 79 With electroporation it is possible to reprogram cells into embryonic cells. “Stem cell breakthrough: safe and ethical”, Bioedge , (March 6, 2009). 80 E. Olsthoorn-Heim, Evaluatie Embryowet , (The Hague, June 2006), p. 98.

cloning. At the moment, in practice, there seems to be uncertainty in embryos which are not viable. If the definition of an embryo as we know it now will it not see these type of embryos, this will have enormous impact on the research. Prohibited actions with embryos as we know now are then possible. So when the legislator also wants to protect these non viable embryos this definition should be changed.

4.3.2 The Dutch Act Medical Scientific Research with Humans (Wet medisch wetenschappelijk onderzoek met mensen, WMO)

The second Act I see as related with therapeutic cloning which I will discuss is the Act WMO. 81 This Act regulates protection of the experimental subject against the risks and objections of medical-research, but the progress of the medical research should not be hampered with this protection. 82 This protection will be achieved by a mandatory commission which will test every case by protocol. Only after a positive advice of the commission medical research is allowed. 83 This advice covers the risks of the research and also research interest taken into account. Besides this, the research should lead to new knowledge in the art of medicine, and this same result could not be achieved by an alternative method. The age and the capability of the experimental subject are also of importance and bounded by rules. 84 The person should also give written consent for the research after he is properly informed about it. 85 This act in fact contains a quite similar range of requirements as the Embryo Act knows, again based on international legislation like the Convention and its Additional Protocols. Research is allowed when all requirements are fulfilled. And all these requirements are also the problem in the WMO. These requirements cause enormous bureaucracy. 86 Unfortunately this cannot be solved. The procedures are elaborate because of all the risks that must be protected, and this should remain so.

81 Wet medisch wetenschappelijk onderzoek met mensen, Stb. 1998, 161. 82 J. Dute, Evaluatie WMO , (The Hague, December 2004) p.7. 83 Wet Medisch wetenschappelijk Onderzoek, Art 2. 84 ibid, Art. 4 and 5. 85 ibid, Art. 6. 86 J. Dute, Evaluatie WMO , (The Hague, December 2004) p.213.

4.3.3 The Dutch Act Foetal Tissue (Wet Foetaal Weefsel)

The third Act concerning therapeutic cloning is the Act Foetal Tissue. 87 Immediate cause for an Act like this was the need for treatment of patients with the Di George syndrome, a rare innate disease. At that moment human research was only possible in other countries and so the Dutch Health Council decided that research to the use of human foetal tissue for transplantation was useful and of importance. 88 Conserving and using foetal tissue after abortion (spontaneous or induced) is, according to this act, permitted only for specific purposes and under strict conditions. 89 Use is only permitted for medical purposes and biologic scientific education, and not for the treatment of a person via the woman. The woman should also give her written consent for the use of the foetal tissue, after an exact intention and purpose of the use of the tissue is given to her. 90 The tissue should not be traceable to the woman or her partner, only when this is necessary for a specific purpose. 91 It is also of importance that donation of the foetal tissue will not result in a financial compensation. 92 Also this act has similarities in requirements for donating material with other related Dutch acts and is based on international legislation as well. What I find rather strange is the fact that the government intended to have no active promotion for donating foetal tissue. 93 I agree that spreading leaflets is a too aggressive way of promoting, but it being mentioned by doctors is in my opinion a soft and acceptable manner. The danger could be that doctors advise can be seen as not objective, in my opinion this argument is not valid, doctors are generally considered to be objective and this will not change if they “promote” this type of research. And if I am honest, it is great to give a tribute to science this way.

87 Wet Foetaal Weefsel, Stb 2001, 573. 88 E. Olsthoorn-Heim, Evaluatie Wet Foetaal Weefsel , (The Hague, June 2008) p.67. 89 Wet Foetaal Weefsel, Art. 2. 90 ibid, Art. 4. 91 ibid, Art 7. 92 ibid, Art. 9. 93 E. Olsthoorn-Heim, Evaluatie Wet Foetaal Weefsel , (The Hague, June 2008) p.20.

4.4 Overview

Besides the three Acts I have discussed in this chapter of course there are more applicable Dutch legislation. Here I can mention the Act on Special Medical Operations 94 , Act on Medical Examinations 95 , Act on Population Screening 96 , and more. Internationaly there is also more legislation, such as EU treaties. But there is too much, and so I have chosen for an organized legal view in this topic of therapeutic cloning. I can conclude that international legislation leaves room for research in human genetics, which includes therapeutic cloning, as long the human rights are not violated. The only specific prohibition is human cloning. In my opinion the prohibition of reproductive cloning is something to respect, I think it will not be useful and not necessary to clone people in the way the sheep Dolly was cloned. Therapeutic cloning is in my opinion different, because the purpose of this cloning differs. The creation of a genetically identical person and the creation of tissue own material for medical purposes. There is a medical need for genetically own material for people with diseases like Parkinson’s and ALS. And there is no need for genetically similar other persons. In my opinion governments are a bit reticent in allowing techniques which are related to human genetics such as therapeutic cloning because of the possible risks. There is an exception: the United Kingdom. The British are advanced when it comes to human genetics. They have the Human Fertilisation and Embryology Act 1990 97 , which is set up to regulate IVF treatments and human embryo research, as well as the regulation of the storage of gametes and embryo’s. 98 Since August 2004 therapeutic cloning with the use of human embryo’s, is allowed there. So there is progress in human genetics. The British do research, and abolished a ban on embryonic stem cell research. Now even President Obama of the United States declared for stem cell research, progressive results won’t be left waiting for long anymore. A promising thought in my opinion.

94 Wet op Bijzondere Medische Verrichtingen, Stb 1997, 515. 95 Wet op Medische Keuringen, Stb 1997, 636. 96 Wet op Bevolkingsonderzoek, Stb 1996, 335. 97 Human Fertilisation and Embryology Act 1997, available at: http://www.opsi.gov.uk/Acts/acts1990/ukpga_19900037_en_1 (accessed at April 16, 2009). 98 “Human Embryo Research in the UK”, Human Fertilisation and Embryology Authority, available at: http://www.hfea.gov.uk/docs/HFEA_Human-Embryo-Research-06-07.pdf (accessed at April 16, 2009).

5. Future

As seen in the previous chapters therapeutic cloning is a controversial technique with ethical and legal boundaries. Main problem of this technique, more objectives, is the use of embryos in this research. People think this research is morally unacceptable. New life should not be killed. I partly agree with this opinion. Partly because factual research will take place on laboratory made embryos or abandoned ones, this includes non viable ones as well. A legal framework in the Netherlands concerning this research, like for example the Embryo Act, regulates the use of embryos and other tissue. There is also another boundary in this genetic research: technical boundaries. In this chapter I want to expose these technological boundaries which come with therapeutic cloning and other genetically research. Besides this I want to make clear that there are more sciences concerning genetics such as neurosciences, which can be entitled as real human enhancement. Where are the lines in what an acceptable enhancement is, and what is not?

The moment of technical boundaries in genetic research maybe will be closer than we think, possibilities of genetic research are limited. In a short period, I believe, it will be possible to create cells, tissue, organs and even bodies with the result of genetic research. This genetic research will predict and solve diseases. But is this human enhancement? I think the predicting part is not more than a new chapter in a biology book., understanding nature. With this better understanding of the human, new possibilities arise: like the discussed therapeutic cloning. We are already transplanting donor-organs with the risk of rejection, why not use tissue of human origin?

Human cloning is the most extreme possibility of genetic research people can imagine. In fact twins already are natures clones and so we know that having a genetically equal other person will not mean a totally equal person, character and personality of the twins differ. With a laboratory made human clone this will not differ from natures clone. But this argument will not be necessary I think. Human cloning is legally bounded, read no option according to current (international) legislation, and I think there will be no government who will allow this technique in the near future. So we do not have to be afraid of this extreme possibility.

Where we, in my opinion, have to be more afraid of are neurosciences. I was rather shocked when I first saw professor Kevin Warwick. 99 This man is a living example of extreme thoughts of human enhancement.

5.1 Neurosciences

Neuroscience is the study of the nervous system, which includes the brains, but also the spinal cord, networks of sensory nerve cells and neurons. It is a study in understanding the human behaviour, thought and emotion. The search for how the nervous system develops and functions normally, which leads to understanding what goes wrong in the nervous system in case of neurological disorders. Here fore different tools are being used, like for example computers and chemicals. 100 In my opinion, with this study, there are progressive developments made which can be called rather amazing. Deep brain stimulation (DBS) in case of Parkinson’s disease is a nice example of an amazing development. DBS is used to treat a variety of disabling neurological symptoms such as tremor, rigidity, stiffness, slowed movement and walking problems, common for Parkinson’s disease patients. By DBS a medical device, called a neurostimulator, will be connected to a thin insulated wirer (called the lead), which is implanted on an exact target in the patients brain. The neurostimulator, in fact similar to a pacemaker, causes electrical stimulation to areas in the brain that control movement by blocking the abnormal nerve signals which cause the Parkinson’s disease symptoms. These electric impulses interfere with and block the signals which cause the Parkinson’s disease symptoms. 101 This makes it possible for patients to control their own body again. Many movies are available on the internet where you can see the effect of the neurostimulator switched on or off. People who hardly can move, are by switching the stimulator on, able to act and live normally. This same trick can also be done by patients who suffer from a major depressive disorder (clinical depression). These are not just depressed, but these people have an extreme mental status which can be characterized by a low mood, and a low self-esteem and loss of interest or pleasure in normally enjoyable activities. 102 When these people are

99 Kevin Warwick is the First human Cyborg. See his website at: http://www.kevinwarwick.com, (accessed at April 6 2009). 100 See Society for Neuroscience at: http://www.sfn.org/ (accessed at April 7, 2009). 101 See National Institute of Neurological Disorders and Strokes at: http://www.ninds.nih.gov/disorders/deep_brain_stimulation/deep_brain_stimulation.htm (accessed at April 9. 2009). 102 Wikipedia “Major depressive disorder”: http://en.wikipedia.org/wiki/Major_depressive_disorder (accessed at April 8, 2009).

undertaking a DBS treatment, literally the sun will shine again for them. Possibly this treatment will also have a similar effect on patients suffering many other disorders. It is above my imagination, probably again because of my non biology background, how this stimulation of the targets like the thalamus, the subthalamic nucleus and the globus pallidus works. In my opinion this kind of science is far more ethically unacceptable in comparison to stem cell research. By reflecting these technical neurosciences, were putting an iron wire in a persons brain diseases can be solved, I can imagine people consider this as an inhuman remedy.

5.2 More extreme enhancement

But there is more, in fact these possibilities of neurosciences are only the beginning. More extreme is the earlier mentioned professor Kevin Warwick. In August 1998 he had a surgery where a silicon chip transformer was implanted in his forearm. This was an experiment where a computer monitored Warwicks movements. Warwick was able to open doors by a unique identifying system in the chip. This was only the beginning of his cyborg life. Later, in 2002, he again experimented on himself. This time he had implanted a chip which could send signals from his nervous system to a computer and back. His wife, Irena, also had implanted a chip which led to a nervous connection between the both of them. This experiment was done to understand how much information the nervous system, and the brain, will accept and adapt. 103 This technique, in theory, should make it possible to upload knowledge to your own hard disk: your own brain. This form of human enhancement goes even further than the DBS treatment, experimental, but a serious step in understanding the nervous system, a serious step in neurosciences. The question here is do we need to know? Do we want to become, in a certain way, machines which can be uploaded with information and repaired? This seems as a robot life to me. Real robots are a project of Warwick as well, robots with rat brains to be exact. The experiment started by spreading rat neurons onto an array of electrodes which eventually formed connections with each other. After this, the new brains were fed with nutrients and minerals and were connected to simple robots with only two wheels and a sonar sensor. The brains dictate to the robot what to do and make it moving. By trial and error the robot is even learning to avoid obstacles. This is called the Hebbian learning, where by doing something habitually, you will get better by doing it. At the moment the robots will be thought to react on audio input, to try to

103 Kevin Warwick: http://www.kevinwarwick.com, (accessed at April 9, 2009).

communicate with the robots, and the range of other sensory input is not limited yet. This whole study on robots is for a better understanding of the brain, studying the ways these robots learn and store memories may provide in new insight in neurological disorders like Alzheimer’s disease. 104 I hear you think now, let’s hope so. This could also lead to a new race of mankind. But, although these possibilities of neurosciences are, at first sight, shocking developments, I think this will lead to further enhancement of humanity. In my opinion Warwick is searching for the ultimate technical possibilities. The possibilities are there, so lets use them and discover! Just like the moon was discovered.

5.3 Immortality

Immortality is an often used futuristic topic in many movies and books, you can think of the Bible, but also Shakespeare’s plays contain this idea. 105 The fantasy of endless living is a nice thought but in fact an utopia. Diseases like AIDS will still destroy humans body and cars will still kill a person when he is hit by it. What is possible is extending our lives. In fact evolution of mankind has extended our lives already. And we also extend lives by treatment of cancer. But extreme extending of our lives, do we really want to reach the age of 200? Our bodies will possibly need serious therapy to make that possible. New diseases also will pop up and other problems will arise. Here you can think of overpopulation. But also on extreme boredom of people who survived all their family and friends. I don’t even mention the costs aspects. 106 No, in my opinion this is not a future perspective of the possibilities of human genetics. It will probably extend our lives a bit further, because more diseases can be solved, but not in an extreme way as new heart cells to repair the damaged and old heart. This, in the near future, will not be a possibility.

104 J. Kloc, “The Living Robot”, SEEDMagazine , (March 26, 2009). 105 J. Harris, Enhancing evolution (Princeton University Press, 2007) p.59. 106 ibid, p. 61.

5.4 Prospective

As seen with neurosciences there are many possibilities. From the unbelievable (the DBS treatment) to rather the extreme (the rat brain robots). With this chapter I want to prove that, compared to the already controversial stem cell research, there are other, more extreme possibilities in human genetics. These other possibilities can be seen as human enhancement, which makes (embryonic) stem cell research not that controversial at all. Although I encourage sciences, and so have no objection to these type of projects (both genetic and neurosciences), I can imagine peoples disapproval in human enhancement. Again an ethical discussion can be held. These extreme possibilities with the human brain sound like a super-robot-human. Do we need these types of enhancement? Do we want these types of enhancement? A first thought is probably that we as humans are ok at the moment. Changing would be against nature and because of that, there is no reason for technical enhancement. But let’s try to be honest, in the past centuries humans are changed, more enhanced, and that development will go on, with or without the help of science. The same can be said in genetic research. Development will go on and we do enhance ourselves. But seen the neurosciences, genetic research is not something to be afraid of anymore. As said developments made in this research will only lead to better insights in the human body and probably make it possible to find answers to diseases. Which will enable us to give better medication, or create tissue own donor material for treatment of patients. I see it as better medical treatments, not as enhancement of humanity. Recently, March 2009, British and Canadian scientists found a way to reprogram adult skin cells into pluripotent stem cells with a technique which is called electroporation. 107 With this technique genes are added in to a cell though its pores. With an electric pulse these cells reprogram the cells they are inserted in, and after that they can be removed again. This leaves a healthy embryonic stem cell-like cell behind. This technique, although further research is required, leads to the end of the ethical discussion in the need of embryonic stem cells. So the grounds of ethical objection in this type of research are, with this new development, taken away. As I said, development continues. This is a new step, probably in other controversial techniques and studies also less inhuman methods will be found. What the future will bring is uncertain and we can only guess. What is certain to me is that this opinion of inhuman and unethical research is only relative. Developments are going fast,

107 “Stem cell breakthrough: safe and ethical”, Bioedge , (March 6, 2009).

and our opinion about these developments is changing together with it. When developments at first sight can be seen as controversial and unacceptable on moral and ethical ground, they later can be seen as valuable. My opinion then is, don’t be afraid of at first sight controversial techniques in human enhancement. What is theoretically possible in laboratories will maybe even not result in accepted medical treatment. What is, and certainly what is not, acceptable will be regulated well by governments. And these governments are rather careful with acceptance of these techniques.

Therapeutic cloning, in my opinion, has the future, and is not that controversial when you compare it with the possibilities of neurosciences. In neurosciences there should be some boundaries because in my opinion, although I find it really exciting, I can imagine moral acceptability of technical possibilities is, at the moment, a step too far. Here I think of the extreme experiments of Professor Warwick, these will, in the near future, not have direct benefits for human mankind. On the other hand DBS is a great step in improving our medical treatments. So I can state my red line in possibilities in human enhancement is that development, how shocking initially it is, is allowed as long as there are provable benefits for medical treatments. Similar to human genetics, also here is the guideline in acceptability the utilitarian balance of benefits together with the autonomy. But also here this could lead to rather shocking therapies. Therapies which really enhance our lives, physical, like a sportsmen, but also intellectual to improve the storage of knowledge. Fortunately these techniques are not available for the clinical practice, yet. This gives us time to see whether these techniques are that useful as is promised.

6. Conclusion

When people talk about cloning most of them will take fierce opposition against this technique. The most common example of cloning is the sheep Dolly (1997-2003). Clones of humans are not known at the moment. These are examples of reproductive cloning, creating a genetic identical animal or person. And this type of cloning is what makes people object to cloning. I agree that reproductive cloning is something we should not allow. Fortunately legislation is based on this same idea. Article 1 of the Additional Protocol concerning the Application of Biology and Medicine on the Prohibition of Cloning Human Beings of the Convention for Protection of Human Rights and Dignity of the Human Being states clearly that any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited. And also Article 11 of the UNESCO states clearly that techniques contrary to human dignity, such as reproductive cloning, are prohibited. In this thesis cloning is not a topic of discussion. Therapeutic cloning, and with this embryonic stem cell research, is. Because the name therapeutic cloning implies the word cloning people tend to object this technique. One of my main points in this thesis I want to make clear is that most objection is based on unknowing of non experts. People do not know how this technique works exactly and hear the word embryo and then conclude in non acceptance. Just like many people are against PGD testing because it is ethically not acceptable to select a child. But the phase of the embryo where research is done is not more than a cluster of cells. In this phase the embryo will not feel, think or do anything. So I don’t see the objection at all.

6.1 Ethics

With therapeutic cloning comes a whole range of ethical arguments. As I described there are three types of ethical views which return in every discussion. They are the Utilitarian, the Dignitarian, and the Human Rights perspective. Together they form the Brownswords bio-ethical triangle. The Utilitarian view is a cost-benefit analysis and the best arguments win. Not a bad perspective because every argument will be heard, but it is uncertain which side will win the discussion. The British are an example of this Utilitarian perspective. At the moment they allow therapeutic cloning because they see more benefits as disadvantages. The Dignitarian view is merely based on religious grounds and thus their thoughts are rather conservative. In their opinion hassling with embryos is not acceptable, because they consider an embryo as new life and this should not be killed. In fact this is a narrow perspective because counterarguments are

not effective and thus discussion is not possible. I respect religious people and certainly do not want to force my opinion on them. But when these religious statements have an overhand in political discussions I think this is an outdated manner of policing given the fact religion is loosing in popularity. There should be a compromise. Religious people should be able to choose a treatment which is not controversial for them, as the way they can choose not to vaccinate their children. Treatment with the use of therapeutic cloning should not be enforced, but an option. The Human Rights view is in my opinion the best perspective. As long as a technique is not contrary to a human right it is acceptable unless the person concerning has personal objection on the technique. This leaves the choice for using controversial techniques where it belongs: an autonomous decision of the person concerning. The line in where to go with human genetics can differ per person. Ethically there can be given many arguments pro and contra. But which view has to be leading? As said, in my opinion, the Human Rights perspective together with the Utilitarian weight of benefits, should prevail. Human Rights are internationally accepted rights. If a technique is so controversial that it is contrary to these rights, the technique should be prohibited. If it is not prohibited the choice should be at the concerned persons themselves, here they can give all arguments including the religious ones.

6.2 Legislation

Besides ethical arguments pro and contra there is already an international and national legal framework. As seen main point in international legislation is the concept of human dignity. As long as a technique is not contrary to human dignity, it is acceptable according to the Convention and the UNESCO Declaration. UNESCO explicit states that in either way reproductive cloning is contrary to human dignity. But this human dignity is a vague concept. For religious people, dignitarian, this is a more strict concept as for people who consider human autonomy as a greater good. I can conclude that opinions around this human dignity can differ, and so legislation per country can differ. For example our Dutch legislation, the Netherlands signed the Convention in 1997, but have not ratified it yet. But Dutch legislation is rather strict and therapeutic cloning, at the moment, is not allowed. In the UK, who not signed the Convention, therapeutic cloning is allowed. Therefore, it is up to a country itself to decide whether it will or will not accept therapeutic cloning. Also of importance, in my opinion, is the fact that therapeutic and reproductive cloning is combined in the regulation. This is rather strange because there are differences between them in

purpose. So these should not be treated as the same. Now it leads to an unclear situation, if therapeutic cloning can be considered as similar to reproductive cloning and is thus a not acceptable technique, or not.

I want to go back to the discussion about embryos. Embryos are nowadays necessary for genetic research and therapeutic cloning. As said not long ago researchers claimed that they could reprogram adult stem cells into (sort of) embryonic stem cells. This is a major breakthrough! It could mean that embryos in the future will not be necessary for this type of research. And in fact the whole embryo discussion is outdated. Techniques are going fast, so fast that even in the short period of writing this thesis the whole issue seems to be changed. What can we learn from this finding? That at first sight controversial techniques like therapeutic cloning at the end could be not that controversial at all. The discussion seems to be outdated and totally useless. But this certainly is not: discussion is needed for better understanding. It is not the first time, and certainly not the last, where we can conclude that opinions are changed. But what can we conclude when we have a look at the current regulation? With our legislation, and regulation, we are always lagging behind this technique. Because technique is uncertain, it is simply impossible to always foresee in the right regulation although we as legal practitioners want to regulate everything perfectly.

6.3 Conclusions and recommendations

Concluded can be that ethical as well as legal, there are many opinions on therapeutic cloning. Some accept and others not. International legislation forms a base in the prohibition of (therapeutic) cloning, but is not mandatory. Countries are able to decide for their self in legislation around this controversial subject. In the Netherlands, at the moment, therapeutic cloning is still forbidden. Although in the UK it is allowed. In either way this technique leads to discussion in literature as well as in politics. It is difficult to say what is technical possible in the next years. What is sure is that new insights lead to new opinions, which could mean that even reproductive cloning can be an accepted technique in the future. Maybe even human enhancement will be accepted in the future. What is of importance, is that we should always try to regulate, and although we should keep in mind this regulation could be based on misconceptions and that regulation sometimes is too late. This is because we live in an high-tech decennia, where our regulation is always behind

the technique which is developing very fast. Sometimes this implies that a change in legislation is necessary. I encourage sciences concerning human enhancement and understanding of the human body, simply because I am curious. And that is what more people should be. There is nothing wrong with better understanding and this should be stimulated as long as clinical application of techniques are regulated in best afford.

Reference list

Books

• Brownsword, R. (2008) Rights, Regulation, and the Technical Revolution . Oxford University Press • Bostyn, S. (2001) Moderne biotechnologie en recht . Kluwer Deventer • Harris, J. (2007) Enhancing evolution . Princeton University Press

• The Old Testament, Exodus 20:13, available at: http://www.artbible.info/bible/exodus/20.html • Somerville, M. (2000) The Ethical Canary, Science, Society and the Human Spirit . Viking/Penguin Canada, Toronto • Somsen, H. (2006) Regulering van humane genetica in het neo-eugenetische tijdperk. Nijmegen Wolf Legal Publishers • Street, P. (2007), ‘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

Articles

• Beers, B. van (2009)‘De humaniteit van humane biotechnologie’, in: Humane Biotechnologie en Recht . Kluwer Deventer • Brownsword, R (2006) ‘Ethical pluralism and the regulation of modern biotechnology ’in: F. Francioni (ed.) The Impact of Technologies on Human Rights. Hart Oxford • Dute, J. (2004 December) “ Evaluatie WMO ” • Jefferson, D (2006) “The moral status of the embryonic human: religious perspectives”, Ethics and Medicine p.22(1), 9-21 • Kloc, J. (2009 March) “The Living Robot”, SEEDMagazine • Kraft, D. (2007 July) “Everything you wanted to know about stem cells.. But were afraid to ask”, available at: http://www.youtube.com/watch?v=BitVZLX58yg&feature=related • Olsthoorn-Heim, E. (2006 January) “Evaluatie Embryowet” • Olsthoorn-Heim, E. (2008 June) “ Evaluatie Wet Foetaal Weefsel ” • Sinnott-Armstrong, W. (2006) “Consequentialism”, Stanford Encyclopedia of Philosophy available at http://plato.stanford.edu/entries/consequentialism

• Schönfeld, M. (2007) “Kant’s Philosophical Development”, Stanford Encyclopedia of Philosophy, available at: http://plato.stanford.edu/entries/kant-development • Somsen, J. (2009) ‘Humane biotechnologie en recht: regulering, zelfbeschikking en waardigheid’, in: Humane Biotechnologie en Recht . Kluwer Deventer • “Stem cell breakthrough: safe and ethical” (2009 March), Bioedge

Websites

• CBS statistics for religion available at http://statline.cbs.nl/StatWeb/publication/?VW=T&DM=SLNL&PA=37944&D1=a&HD=081206- 1608&HDR=T&STB=G1 • CBS News “Obama Ends Stem Cell Research Ban” available at: http://www.cbsnews.com/stories/2009/03/09/politics/100days/domesticissues/main4853385.shtml • For an overview of countries which signed the Convention see: http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=8&DF=5/19/2009&CL=ENG • Dutch code for health insurances, available at: http://www.zn.nl/leeszaal/zn_uitgaven/znuitgaven/gedragscode_van_de_zorgverzekeraar.asp • Gentechnologie: evolutie op zijn snelst, http://proto.thinkquest.nl/~llb109/klonenth.html • “Human Embryo Research in the UK”, Human Fertilisation and Embryology Authority, available at: http://www.hfea.gov.uk/docs/HFEA_Human-Embryo-Research-06-07.pdf

• Kevin Warwick is the First human Cyborg: http://www.kevinwarwick.com

• Society for Neuroscience at: http://www.sfn.org/

• National Institutes of Health. “Stem Cell Basics”: http://stemcells.nih.gov/info/basics/basics2.asp • National Institute of Neurological Disorders and Strokes at http://www.ninds.nih.gov/disorders/deep_brain_stimulation/deep_brain_stimulation.htm • Publications about the Embryo Act of the Dutch Ministry of Health Welfare and Sports available at: http://www.minvws.nl/folders/ibe/hoofdlijnen_van_de_embryowet.asp • Secretary General of the Council of Europe, Explanatory Report of the Additional Protocol . Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm • Secretary General of the Council of Europe, Explanatory Report of the Additional Protocol . Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/203.htm • Secretary General of the Council of Europe, Explanatory Report of the Additional Protocol . Available at: http://conventions.coe.int/Treaty/EN/Reports/Html/168.htm

• Standpunt preïmplantatie genetische diagnostiek Kamerstuk, 26 mei 2008 available at: http://www.minvws.nl/kamerstukken/pg/2008/standpunt-preimplantatie-genetische-diagnostiek.asp. • Wikipedia “DNA”, http://en.wikipedia.org/wiki/DNA

• Wikipedia “Embryo”, http://en.wikipedia.org/wiki/Embryo

• Wikipedia “Introduction to genetics”, http://en.wikipedia.org/wiki/Introduction_to_genetics

• Wikipedia “Major depressive disorder”: http://en.wikipedia.org/wiki/Major_depressive_disorder

• Wikipedia “Miscarriage”, http://en.wikipedia.org/wiki/Miscarriage

Legislation

• Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Biomedical Research, Strasbourg January 25, 2005. Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm • Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg November 27, 2008. Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/203.htm • Besluit genetisch gemodificeerde organismen Wet milieugevaarlijke stoffen, Stb. 1990, 53. 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 and Biomedicine, Oviedo, April 4, 1997. Available at: http://conventions.coe.int/treaty/en/treaties/html/164.htm • 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 and Biomedicine, Oviedo, April 4, 1997. Available at: http://conventions.coe.int/treaty/en/treaties/html/164.htm • Directive 90/219/EEC available at: http://www.biosafety.be/GB/Dir.Eur.GB/Cont.Use/90.219/TC.html • Directive 90/220/EEC available at: http://www.biosafety.be/GB/Dir.Eur.GB/Del.Rel./90.220/TC.html • Embryowet, Stb 2002, 338 • Human Fertilisation and Embryology Act 1997, available at: http://www.opsi.gov.uk/Acts/acts1990/ukpga_19900037_en_1

• Protocol to the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine on the Prohibition of Cloning Human Beings, Paris, January 12, 1998. Available at: http://conventions.coe.int/Treaty/EN/Treaties/Html/168.htm • UNESCO Universal Declaration on the Human Genome and Human Rights, November 11, 1997. Available at: http://portal.unesco.org/en/ev.php- URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html • Wet op Bevolkingsonderzoek, Stb 1996, 335 • Wet op Bijzondere Medische Verrichtingen, Stb 1997, 515 • Wet Foetaal Weefsel, Stb 2001, 573 • Wet op Medische Keuringen, Stb 1997, 636 • Wet medisch wetenschappelijk onderzoek met mensen, Stb. 1998, 161 • (2005) 40 EHRR 12