Genetics and DNA Technology: Legal Aspects

Name: Genetics and DNA Technology: Legal Aspects
ISBN: 9781843146995

doi:10.4324/9781843146995

Book

Genetics and DNA Technology: Legal Aspects

ABSTRACT

First published in 2005. This second edition of Genetics DNA Technology retains the original's focus on professional lawyers. Not a law textbook, it is an adjunct to those who are studying law or want to become forensic scientists.

balances) which should have been asked before the introduction of some new technology were not. Think of it in another way. Trying to frame up general questions to cover all eventualities will not work when there are so many conﬂicting interests at stake. Without a specific idea of the sorts of ethical questions we would like answered we are working in the dark. Unfortunately, philosophers and theoreticians, who study ethics tend not to deal in speciﬁcs, but try and formulate rules and frameworks of thought which can then be adapted to speciﬁc questions. This may seem a rather soft approach, but it does at least have the merit of being able to help in answering, if not actually answering, a question in the future which was not even dreamt of when the theoretical consideration of ethics started. Stevenson, in Ethics and Language (1944, New Haven: Yale UP), tried to demonstrate that ethics can be a rational discourse, by saying that if an individual says that tolerance is good the individual is approving of tolerance, but also more signiﬁcantly, suggesting that you do as well. If you do not, then you have to be persuaded, but that implies a value judgment on the arguments which are to be put to persuade you that tolerance is good. The idea of persuasion is an interesting one, because the philosopher is always trying to produce an algebraic description of ethics and morals. The other end of the spectrum is the case where it could be stated that what is true in one case, or held to be true by an individual in a particular case, must be true in all other cases. One could logically see that this latter case would result in a paciﬁst point of view, that is, it is not right to kill so I will not kill, ie a general philosophical idea of ethics taken as a personal guide. Where this and every other argument falls down is in cases where a terrorist says it is correct for me to kill, but not for you. Such moral conundrums have stretched moral debate since the dawn of rational thought, with solutions being found in every moral and ethical document, whether religious or secular. But where does this lead us in terms of the legal aspects of the application of DNA technology? In a way into a more complicated world, but also one far more relevant to the individual than a theoretical argument. DNA proﬁling affects the individual far more than any aspect of the other sciences. Physics has never singled out an individual; like chemistry the moral repercussions these sciences have wrought have been on a grander scale. You may be a victim, but you are not alone. This will be small comfort to the victim, but there is solidarity in social cohesion. DNA is different. It can be used not only to single out the individual, but also to penalise and degrade that individual. The first thing to be said about ethical questions is a very practical one. It assumes a benign State, a regime which is trying to do the best for the population as a whole. A tyrannical regime of any sort can do what it likes and therefore does not have to be morally accountable for its actions. This point is important because in a benign State it is everyone’s right, if not duty, to challenge morally repugnant actions. In such a State it is legal action which is the immediate point of challenge to such behaviour, whether it is an individual committing a crime, which we have collectively decided is not acceptable, or a government behaving in a manner

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which a social group or individual thinks is wrong. So the ﬁrst port of call will be the courts, where we should be able to expect an independent judiciary. However, it is also true that sometimes actions and decisions are taken which, although in themselves not contentious, accumulate along with other legislation to create a highly questionable situation. Note here that the situation becomes questionable: an interpretation of the rules becomes possible which some would simply not agree with. For example, progressive attitudes towards free speech has resulted in the situation being taken advantage of by extreme groups for political ends. There are a number of very speciﬁc points which can be made about the use of DNA by society and more especially the construction and use of DNA databases. It is unlikely that anybody would really object to construction of anonymous databases so that we can produce a precise and reliable ﬁgure for the probability of ﬁnding a DNA proﬁle in the general population by chance alone. What many people do have objections to is the construction of databases of named individuals. Strangely, it would seem that the country that has always been in the van of development of DNA technology is developing a rather poorer reputation for riding roughshod over the rights of its population, the UK. The problems and objections with databases of named individuals start with the practitioners and political will by successive governments. Luckily, there is an outspoken reaction to the UK government’s belief that all uses of DNA are good, but we should be aware that this is not so. Current thinking is that in the future it will be possible to determine facial shape, such as nose type and eye colour, with a simple test. This is put forward as a distinct possibility by the Forensic Science Service, with little regard to the extreme complexity of both the genetics and the environmental input into such things, not to mention plastic surgery. While it was always the belief that rapid turnaround of DNA results would be a good thing, this is only if the techniques are highly controlled. The idea that a hand held machine, as has been suggested, could be taken to a scene of crime and the DNA analysed in situ should ﬁll any self-respecting scientist with horror. It has already been stated that there is a 40% chance of a stain found at a crime scene being linked to a name on the database of named individuals. As databases become larger as well as the number of individuals putting data on the database, so the likelihood of error increases; remember that error in this sense is quite likely to ruin a life. Names get onto databases for perfectly innocent reasons. Two of these are the husband or partner of a rape victim and, which is even more demeaning, the DNA proﬁle of the victim herself. This was admitted in the House of Lords. So why is the British public so lacking in interest or apparently not in the least bit bothered by this staggering lack of feeling for the innocent? There is no mechanism for the removal of a DNA sample from the database after consent has been given. It is of interest here that both the police, forensic scientists and politicians are extremely reluctant to give a sample which can be held on the named database. Why is this? Fear? Fear of what may be done with such intimate information. This includes medical analysis and data which they have no right to access. It would be

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very easy for sensitive medical information to be accessed and sold by unscrupulous individuals that had access to the DNA database. Not only that, but with the increasing use of DNA in medical situations, the absolute protection of results of analysis cannot be guaranteed against seizure by law enforcement agencies. An interesting aspect to refusing to give a sample voluntarily is that such refusal raises an air of suspicion. This in turn gives an aspect to proceedings in court which move from innocent until proved guilty towards guilty until exonerated by DNA. This is simply not how it should be. The more and more samples on the DNA database, the more likely it becomes that a chance match results in a wrongful conviction. As of early 2004, Canada and France have shown a greater degree of responsibility than the progressive belief of the Forensic Science Service that they can get away with any infringement of what is very personal information. What Canada and France have done is made it mandatory that samples from accused persons who are subsequently not charged or acquitted should not be retained. Even more sensible, if samples are taken from juveniles, even if convicted, they will be destroyed when the individual becomes a legal adult. As we in the UK seem to be marching towards institutional control of our most personal information, American law enforcement agencies are astonished that in the land of the free we seem to have no interest in a public debate of what might become not just control of information, but control of the individual. 2 Cloning as a legal issue

It is also true that scientiﬁc developments have taken place which throw up new possibilities which, rightly or wrongly, were not foreseen and cause consternation amongst the public and legislators alike. A case here would be the cloning of Dolly the sheep. This was the ﬁrst cloning of an adult sheep, but although everyone seemed surprised by this it did not happen out of the blue. It should have been

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The important point here is that no act of fertilisation is involved and it is on this point that the arguments were made. The original Human Fertilisation and Embryology Act 1990 was amended in 2000 so that cloned embryos were covered, but the deﬁnition of an embryo, that is a fertilised egg, was not altered. Since a cloned embryo has not undergone fertilisation it is not in fact covered by the Act. So although a contradiction in terms, for the purpose of the law a cloned embryo is not an embryo. The outcome of this was that the High Court decided that the licensing arrangements for embryo cloning did not hold for implantation of cloned embryos. All of a sudden it became apparent that producing an infant from a cloned adult cell was not ruled out. This legislative anomaly was that it should never have been exposed by a court ruling; it should have been dealt with by Parliament long ago. When Dolly the sheep was born in 1997 it was immediately obvious that sex may not be the only way to produce new offspring. In the US, the government quickly took this on board and revised its own definition of an embryo. In the UK, the committee of MPs dealing with science and technology warned the government of the potential problems this deﬁnition of an embryo might cause. On Friday, 18 January 2002, the Master of Rolls, Lord Phillips of Worth Matravers, sitting with two other judges, said that an embryo created by cloning did fall within the legal definition of an embryo, even though no fertilisation had taken place. This ﬁnally brought human cloning in the UK for medical research into the Human Fertilisation and Embryology Act 1990. Whether you agree or disagree with the principles involved there are many questions which are raised. Broadly speaking, there are two types of cloning in use here. One is cloning fertilised embryo cells and the other is cloning of other cells. But what is the difference? If nature can, and does, produce complete individuals from a single cell, then at what point do we say that cloning a cell is tantamount to usurping the position of nature. But it is the very nature of human curiosity to try to understand the world about us, including how it is that we cannot artiﬁcially create a viable organism. Put bluntly, if it happens in nature, why can’t we do it? This debate is complicated because identical twins can be seen as clones of each other. Although semantic debates in themselves can be interesting it would at this stage be worth considering what we mean by ‘clone’ and why it results in some very specific grammar. A clone is any group of cells, which includes a complete organism, which derives from a single progenitor cell. So Dolly the sheep is a clone of her mother, cloned from a cell of her mother. Identical twins are clones of each other from an original ovum. So not only do we clone by accident, in the case of identical twins, but for at least the last half century we have been cloning human cells deliberately and this deliberate cloning has been done in the quest for methods of prenatal diagnostics. When foetal cells are removed so that they can be tested for large scale genetic defects, such as Down’s syndrome and other conditions not compatible with life, the cells are routinely grown before the testing is carried out. Each group of cells is a clone of the ﬁrst one which started dividing, each clone has the entire genetic content of the foetus from which it originated, but no one would suggest that there is sentience or soul present. Many of the samples of cloned cells are then frozen

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and stored, such that they can be defrosted and grown on again later. This is cloning and storage of human cells in exactly the same way that cloning and storage of human embryos is. In many ways they are separated by a distinction without a difference and I would not like to be the person that had to tell a seriously, or even terminally, ill individual that it is not possible to treat them because the only way is to produce immunologically sound material which they will not reject by cloning – and that this is not allowed. It was decided on 15 November 2001 that cloning of embryos for therapeutic research should no longer be licensed, but cloning one for birth apparently is and there are medical practitioners who seem to think that this is a good and practical idea. It is suspected that the incredibly high failure rate of cloned foetuses will mitigate against pursuing human clones. To put numbers on this, of 277 attempts only one sheep, Dolly, was born and further successful examples of animal cloning have been just as hard won. However, failure in this context is not a simple, clear, non-viable embryo; it includes gross malformations and developmental problems. These would not be an acceptable outcome in human cloning. This problem of not thinking about questions on a ‘what if?’ basis before the practical necessity arises is exactly the same situation that seems to have occurred with DNA proﬁling and genetic testing for disease genes. We have simply not been ready as a society to address questions that are going to have profound effects for future generations. This, sadly, is a general failing. Statements such as ‘think of the children’, have very little power to motivate; what does motivate seems to be political will and commerce. It is true, as discussed earlier, that large numbers are not easily conceived of. What is also true is that long periods of time are not easily comprehended either. So, to take an example from a different science, but one which is very real now and can therefore give us pointers to the future of our ethical problems in genetics, let us consider the question of nuclear waste. We can visualise this not just as a physical problem but an ethical one which is dependent upon society and the good will of society as well. The long term control of nuclear waste is a problem. No matter how it is stored or dealt with it needs to be looked after for a very long time. Given the half-life of some of this material – that is the length of time it takes to reduce its radioactivity by half – the storage times are prodigiously long. It is not unrealistic to say that storage should be in excess of 10,000 years, but no civilisation has been around that long and it would require a great leap of faith to suggest that the current nuclear powers would remain intact, politically stable and ﬁnancially able to look after such a potential problem for so long. It is to be hoped that humanity is going to out-last nuclear waste, but the questions regarding political stability remain. We simply do not know what sort of a government we will have 1,000 years hence; we do not know what sort of data they will hold about our genes, so now is the time to question their perceived right to hold such information. Now is the time to challenge the perceived right of testers to take samples to ﬁnd out whatever they like about an individual and possibly pass it on.

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3 Insurance and genetics

What we are talking about here is a type of right to privacy that has never been tested before: the right to deny any access to your genetic data. If we do not have that then we become public property. It should not be forgotten that taking a sample and testing it does not actually destroy the sample. It can be stored and used later for further tests as the technology develops. Here I do not mean just

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An increasing concern amongst geneticists is epidemiological data, as well as personal data, which is then used by insurance companies. This is an immense source of concern for several reasons, but before looking at the reasons for our concern, it would be well to look at the mode of inheritance which many of these genetic disorders follow. Those genetic conditions of which the public is most aware are often inherited in a relatively straightforward way. Among these we can count cystic ﬁbrosis, sickle cell anaemia, Huntington’s chorea and Duchenne muscular dystrophy. The most straightforward inherited condition of these are cystic ﬁbrosis and sickle cell anaemia; you can be an unaffected carrier with one defective gene, but one perfectly normal one which functions correctly and that is all you need. If you should marry another carrier, however, simple patterns of inheritance indicate that the probability of producing an affected child is one in four; the probability of producing a non-carrier child is also one in four. The probability of producing a carrier child is one in two, or 50%. This is a probability, nothing more, so who should have access? When it comes to Huntington’s chorea the situation starts to become a little cloudy and, with further examples which we shall look at, will become very difficult to interpret. Huntington’s chorea is generally considered to be a dominantly inherited condition. But wait, why do the onset of symptoms occur at different times of life and with different rates of progression? Surely this means that it is not just a case of dominant/recessive? But if it was, then it would be easy to deﬁne the mode of inheritance. But it is not so easy, even in this case where we can say with certainty that an individual does or does not carry the gene and therefore will or will not have the disease; we are still unable to say when the disease will manifest itself. When it comes to other forms of inheritance the story becomes ever more complicated and the questions which need to be addressed ever more convoluted. A very good example of this is found in breast cancer. It is known that breast cancer is associated with a gene called BRCA1. About 5% of breast cancers are the result of this gene, and about 70% of those women who carry the gene will die as a result before they are 70 years old. But, of course, that leaves us with 30% of carriers who never succumb to the disease. So the question is simple: what protects the lucky 30%? This is unknown and there is no way of predicting if a BRCA1 carrier is in the 70% or 30%. So it is here that the ethical consideration comes in and possibly the legal challenge. Should an insurance company be able either to insist either on an individual having a test, or having had the test voluntarily, be able to insist on seeing the results? I do not think so. No matter what the Association of British Insurers says, its logic is fundamentally ﬂawed. There are two basic reasons for saying this, but it would be well ﬁrst to look at the manner in which insurance works. When calculating insurance premiums, there are two basic ways in which it is done. The first is called mutuality. This keeps all the people at the same risk together and therefore sharing the costs and consequently an insurance company would like lots of low risk people to maximise profits. This is the situation generally used in America where health insurance for some individuals can be impossible to find because they are perceived to be in a high risk group. The

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method normally found in the UK is, at the moment, slightly different. This system is called solidarity; everyone shares the cost of insurance, across the entire gamut of risk. Even so, there have been modiﬁers which have crept in, such as smoking or obesity. In the case of smoking it is a self-inﬂicted injury and, for the most part so is obesity, but not always. Generally speaking, genetic information can be ignored using this model. So we return to our original supposition: why not test everyone and modify their premiums accordingly, which is what the insurance industry would like? Well, to begin with this would be a ‘cherry picking’ exercise. Whatever is said it can be assumed that the truth, now or later, is that if insurance companies were allowed to assess individual risk someone would end up as uninsurable, while those that probably do not need insurance will be quite happily given it. So if the claim is that there is no intention to increase proﬁts, which it has been stated to be, why bother? Is it altruism on the part of insurance companies to put premiums up for one group and down for another? This brings us to point two. If there is no desire to increase proﬁts, why not retain the actuarial system currently in place? Actuarial tables have been used for centuries and give a good guide to the numbers of any age cohort who will die at any given time. This system works for both the insured and the insurer; to change it is to load the dice in a game of chance in favour of the dice holder. The insurers want to bet on a certainty; the rest of us want access to affordable insurance. This is the point where the legal challenge should be pursued. Discrimination in any form is both undesirable and dangerous. It is undesirable because we may lose a signiﬁcant resource in the shape of our genetic diversity. After all, we have seen that some genes which are routinely described as ‘disease genes’ have turned out to confer additional fitness to the unaffected carriers, such as sickle cell anaemia (malaria resistance) and cystic ﬁbrosis (tuberculosis resistance). It is also dangerous because we cannot tell what path this sort of action could lead us down; eugenics is not a very sensible route for humanity to take. A primary concern in this sort of testing is that the individuals that are making judgments on the results of these tests are simply not capable of making them. With any genetic test counselling is essential; without it the misery which can be caused within a family can be immense. Such things should be challenged before the situation becomes uncontrollable. During the Human Genome Project it was discovered that in excess of 1.4 million single nucleotide polymorphisms (SNPs) are present in the human genome. Many of these are of considerable importance in testing for specific genetic conditions, even down to such things as adverse reactions to specific drugs. This will be of enormous beneﬁt because although an adverse reaction may be a simple headache or weight loss, such a reaction can be so severe as to result in death. But SNPs have another practical application in the criminal justice system. They can be used in large panels to produce a DNA proﬁle for identiﬁcation. But even now it is reported that an American company, DNAPrint Genomics in Florida is patenting a test which tests for SNPs that correlate with eye colour. They are not trying to determine eye colour by looking at the genes which actually code for eye colour in their entirety, but at single bases differences which indicate the

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type of gene present and therefore the probable colour of the eye. A test of this type may be available shortly since eye colour is a genetically determined trait, but more fanciful ideas of testing in the same way for height and weight are less likely to reach fruition because of the very high environmental element in these two. This example is a taste of the future. Perhaps individuals and society as a whole will not mind this sort of information being collected, but I would have grave misgivings about collection of such information. Once such tests are available, any unscrupulous regime could start eugenics programmes on very spurious grounds, but justifying them with application of a scientiﬁc test. The use of SNPs forensically is also likely to run into problems if for some reason the ones chosen for criminal investigations turn out later to reveal information about an individual’s health in some way. This may be quite subtle, such as potential for heart disease. If the test has been made and this information is a by-product of the test the question needs to asked as to whether it should have been done in the ﬁrst place and, secondly, whether the tested individual should be told. The individual may not want to know but if the testing authority has information that might be used to improve the health of an individual, does it have a duty to pass this on? Or would the tested individual have the right to say that he or she has been tested for a medical condition without prior knowledge or permission as this is quite separate from the DNA profiling carried out on a sample taken only for that reason? SUMMARY

There is a complexity in ethical questions which has not in itself been adequately addressed. In the past it has been the objective of philosophers to produce general frameworks within which all societies can operate for mutual beneﬁt. What this fails to take into account is the increasing technical complexity of our society, which brings with it questions of a unique nature that cannot be easily described

Genetics and DNA Technology: Legal Aspects

ABSTRACT

TABLE OF CONTENTS

chapter 1|4 pages

chapter 1|12 pages

chapter 2|12 pages

chapter 3|4 pages

chapter 3|2 pages

chapter 3|8 pages

chapter 4|5 pages

chapter 4|15 pages

chapter 5|16 pages

chapter 6|14 pages

chapter 7|1 pages

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chapter 7|1 pages

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chapter 8|4 pages

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