Increasing the amount we understand about genetics will affect all future generations. Our generation is charged with the task of setting the foundations…and building the first few stages. It is important, therefore, that we think clearly and plan well. We need to encourage the scientists, technologists and financiers to step outside the tower1 and look at what they are creating. We need to encourage the public and policy‐makers to stop moaning about the technology and the problems of containing it, and take the effort required to understand enough about it to make enlightened decisions.
Let’s step out of the tower, move away from the shadow and enjoy the light. Let’s make use of genetics and not let it make use of us.
From Babel’s Shadow, Pete Moore (2000)
I thought ‘I’ll prove I’m not a suspect’ but it didn’t pan out that way. DNA has become the magic bullet for the police…they thought it was my DNA, ergo it must be me.
David Butler, quoted by Hannah Barnes in DNA test jailed innocent man for murder, BBC Radio 4, The Report (2012)
I know genes are a big deal, son, but they’re not the be‐all and end‐all… If they were, you’d be in a seafood salad and I’d be in prison.
From Going Grey, Karen Traviss (2014)
In this chapter we will discuss a range of issues that arise from our increasing ability to manipulate DNA in a wide variety of applications. The theme that links the examples is essentially ethical: what should we be allowed to do and what should we be prevented from doing with knowledge about DNA and/or with DNA itself. We can illustrate the complex and often tangled discussion by further reference to GM crops, which were the subject of the previous chapter.
One of the most interesting features of the debate on GM crops in Europe has been the way in which issues not directly related to the technology itself have been brought into play. Some of the most vigorous opposition to these crops has been based on socio‐economic arguments, mainly centred on inequalities in ownership of the technology. Indeed, the possibilities that GM technology may lead to further exploitation of the poor by the rich are, in the views of some, enough to make the technology irredeemable. Typical of this approach is a comment made to us by someone attending a community lecture on GM crops: We cannot consider this technology in isolation from considering who is using it or how it is being used. In other words, the ethical rightness or wrongness of the technique itself became secondary to its use. It is equivalent to saying that because something can be misused, it should be banned.
Thus, even though in Europe, the opposition to growth of crops bred by GM techniques in general is declining, opposition to companies (and one company in particular, Monsanto) who ‘own’ the rights to certain GM varieties (see below) has become more intense. This ‘ownership’ by a large agrochemical company of some GM varieties is, in the eyes of many campaigners, enough to ban the technology completely. This has also led, for example, to concerted pressure for a ban on the use of the herbicide glyphosate (a Monsanto product used in husbandry of glyphosate‐tolerant or ‘Roundup Ready’ crops), pressure that led the European Union (EU) in 2016 ‘failing to agree’ to extend glyphosate’s licence for use as a herbicide2 although it was not actually banned at that time. A recent (March 2017) report3 from the EU’s European Chemicals Agency has declared the glyphosate is safe and the European Commission announced in September 2017 that use of glyphosate would not be banned. In the run‐up to that decision, certain environmental organisations had ramped up their opposition and were thus very disappointed at this decision. And perhaps even more significant is that, in 2016, the European Parliament, acting on a motion put forward by the Green Party, decided to withdraw support from the G84 initiative New Alliance for Food Security and Nutrition in Africa, at least partly because some of the stakeholders in the Alliance are multinational companies and partly because the initiative is seen as representing a ‘new colonialism’.5 It is indeed a somewhat tangled discussion.
We need to say that with many inventions, there may be both ethically good and ethically bad uses,6 but in our view, the latter do not mean that a technology itself should be banned. Further, when the issues mentioned above are examined in detail, it becomes apparent that they are not exclusive to the applications of GM technology in agriculture. Nevertheless, the GM debate has been for campaigners a useful vehicle for airing these issues, acting as a lightening conductor for attracting opposition that could equally be directed at several other aspects of genetic technology, or at the pharmaceutical industry or indeed at several other aspects of modern developments in science and technology. Now, there may be some of our readers who are content to leave it there, seeing socio‐economic ethical issues as being outside their concern. We, on the other hand, suggest that scientists should be concerned with the way in which their discoveries are taken up. This is part of the social responsibility of the scientist. So, in the remainder of this chapter, we discuss important social and socio‐economic issues arising from genetic research and GM technology, namely,
Although there are many millions of hectares worldwide devoted to the growth of GM crops (as noted in Chapter 10), much of this land area is in developed countries or in rapidly developing countries, for example, China. However, in 2015, for the first time, the area planted by small, resource‐poor famers in less‐developed countries added up to more than half the total (54%).7 GM technology is often cited as being a key component of the plant breeder’s ‘toolkit’ in the fight against world food shortages (again as discussed in Chapter 10). Thus, back in 1999, Gordon Conway, the Director of the Rockefeller Foundation, wrote of the need for a second ‘Green Revolution’, The Doubly Green Revolution,8 a focussed worldwide effort utilising the efforts of geneticists, plant breeders and agriculturalists to increase world food production, similar to the first Green Revolution of the 1970s9. At that time, while not regarding crop GM as a panacea for world food shortage, Conway certainly saw it as an important tool in breeding programmes that can thus make a significant contribution to increasing food production. That is still the view of many scientists and policymakers, especially because, sometime in the middle of the 21st century, increases in the human population of our planet are likely to outrun our capacity to produce food (see Chapter 15). However, those who endorse this view are reminded by the opponents of GM technology, of the following:
These are all very relevant points in the argument (and see also Chapter 10) but nevertheless, Gordon Conway and those who support his position argue strongly that we need to continue efforts to increase productivity in order to avoid actual global shortages occurring in the future. Such shortages will exacerbate severely the problems of the world’s poorest people.
However, there is one further factor to be taken into account. The Green Revolution was largely based on research and development by government‐funded laboratories and agencies, by charities and by international non‐profit organisations that formed a diverse network with a single focus. By marked contrast, over the first 20 years of the commercialisation of GM crops, most of the relevant research and development in the world’s wealthier countries was carried out by large transnational companies. Thus, the majority of the research and the resultant knowledge were in hands of about five companies or conglomerates, while government‐funded and other non‐commercial organisations played a relatively minor role in these developments.13 Whatever we think about the profit motive, whether or not we are in general happy with the capitalist economic system, it is clear that there are problems in reconciling the need to make money with the application of a company’s technology in the world’s poorer countries. Indeed, the commercial practices of some transnational companies certainly indicate that profit motive outweighs other concerns. Further, some economists have suggested that the way that world trade is organised, especially under the auspices of the World Trade Organisation, gives the wealthy countries of the world increased advantages over the poorer countries. However, other economists argue, equally strongly, that the WTO’s operations will eventually lead to fairer trading condition. All these factors have led to the suggestion that at present crop GM technology is a powerful tool in the hands of the already economically powerful that may all too readily be used to exploit the poor and the weak. And for some, the argument stops there.
There are also voices saying that this question is irrelevant. GM technology, it is said, is a ‘high‐tech fix’, representing the unacceptable role of ‘big business’ in agriculture and food production and therefore not appropriate for the indigenous agriculture of less developed countries,14 Even developments such as ‘Golden Rice’™ (see below and Chapter 10) are regarded in this way, even though its development has been funded by charities and international agencies.
It is certainly true that developments in plant breeding, whether or not including GM, should be relevant for local conditions and agricultural practices. Farmers who work hundreds or even thousands of hectares of land and who are used to buying seed anew each year have different needs and face different problems from farmers working small parcels of land and who keep each year some seed for sowing in the next. The failure in much of Africa of the Green Revolution in general and of F1 hybrids15 (which do not breed ‘true’ from year to year) in particular is a testament to this. Further, there are certainly some small farmers in less‐developed countries who are opposed to using GM crops, possibly because of fears about being ‘locked in’ to an expensive dependence on wealthy commercial companies.
However, this is far from being the whole story. Several of the most rapidly developing countries, including India and China, have adopted appropriate GM varieties, as have cotton farmers in parts of South Africa, including KwaZulu‐Natal. In both China and South Africa, farmers working small parcels of land are among those who, it is claimed, have benefited from growing GM crops. Further, as we have already mentioned, the area devoted to GM crops in less‐developed countries now exceeds that in developed countries. Agricultural scientists and policymakers who are citizens of and/or based in a number of less developed countries have suggested that GM technology, appropriately applied, may be one factor in establishing local food security. But can this be achieved without increasing dependency of the poor upon the rich or increasing exploitation of the poor by the rich? The answers to these questions involve, at one end of the scale, global economics. However, more local and situation‐specific answers are also arising. Effective measures may include:
It is thus argued that GM technology may take its place, among other developments in plant breeding, within the range of measures needed to improve crop yield and quality in less‐developed countries. According to supporters of this position, the development of ‘Golden Rice’ (a rice genetically modified to increase its vitamin A content),16 the growth and commercial success of insect‐tolerant cotton in KwaZulu and the large numbers of small farmers in China who grow GM crops all point to the success of such approaches.
In further support of this view, at least 140 GM crop varieties are currently in production or under development through government‐funded institutions, charities, international organisations or small local companies: the situation is changing fast.
Many opponents of GM crop technology remain unconvinced, as has been made clear to one of us (JB) in discussions as recently as the spring of 2016. But what of ourselves, the authors? This is one of those places in the book where we need to declare our hand: we suggest that, as a technique in plant breeding, genetic modification has the potential to be used in a non‐exploitative manner in improving crop performance in less‐developed countries. But you, the reader, must make up your own mind.
Having just dealt with some of the problems associated with application of GM crops in less‐developed countries, we move straight into a discussion of one of the more contentious issues that arise in this whole area. The key to the discussion is whether genes fulfil the criteria normally applied in consideration of whether a patent should be granted. So, to set the scene, here is the main question that needs to be answered.
The reason for asking this question is that in order to be the subject of a patent, it must be an invention and not a discovery or a pre‐existing part of nature. Genes are clearly parts of nature; an individual gene, however ingenious the scientist has been in discovering it and characterising it, is not an invention – end of story, or so one might think. However, it is not the end of the story. Genes, including crop genes, have been patented,17 most often in the United States but also within the patent jurisdictions of other countries, including the United Kingdom and other EU countries. We note however that in patent jurisdictions outside of the United States, patenting does not preclude research on the patented object; in the United States there is no ‘research defence’ and anyone wishing to do research on a patented object must pay a royalty to the holder of the patent.
How can genes be patented? The essential argument made by those who support these patents is that there is an inventive step. The patent may be granted, it is stated, because the steps required to isolate the gene from the rest of the DNA and/or to make a copy of it from a messenger RNA population or to ‘write’ it from scratch (see Chapter 9) turn the gene sequence into an invention. Thus it is not the gene itself that is being patented, but a copy made in the test tube. Opponents of patenting genes may well recognise the skill of the molecular biologist but they will add that it is ‘playing with words’ to argue that patenting of a gene copy is not the same as patenting the gene. They will also point out that defining genes as intellectual property in this way is a more restrictive arrangement than the well‐established system of plant breeders’ rights or plant variety rights (protected under the rules of the International Union for the Protection of Varieties of Plants (UPOV)).18 This results in yet more potential for the exploitation of the world’s poor by rich commercial interests.
Supporters of gene patenting, however, having argued that the gene sequence is legitimate intellectual property, go on to state that this a logical extension of the internationally agreed arrangements for granting patents.19 It is argued that the particular way that GM technology has evolved means that this is the only way that companies can ensure an appropriate return on their research and development investment. As for the effect on less‐developed countries, the example of the vitamin A‐enhanced ‘Golden Rice’ is often cited. Although this was developed in non‐profit laboratories, several patents stood in the way of its application. However, it proved possible to negotiate without cost, ‘freedom to operate’ (FTO) agreements in all those instances where a patent would have otherwise proved restrictive. Of course there is no way of guaranteeing that such agreements may be reached in subsequent cases. Indeed, opponents of gene patenting point to the long battle in the world of pharmaceuticals before major companies gave up their intellectual property rights in order to allow the synthesis of generic drugs to deal with that other great scourge of Africa, AIDS.
Patents of course have a limited lifetime. They may be maintained for up to 20 years from the date of filing and a significant proportion of that time will probably have elapsed before the patented ‘invention’ is ready for the commercial market. Thus, in the plant biotechnology sector, many of the patents on specific genes have now expired, leaving them available to be used freely by any company or organisation that is able to do so. This is again pointed out by the supporters of gene patenting: eventually there will be general availability of the gene. In the meantime, the ‘inventors’ have gained an appropriate income from their invention and the supporters of gene patenting believe that this is the only way to ensure a ‘fair’ reward for the time and money invested in the research and development.20
As well as being a contentious issue in crop GM technology, gene patenting is equally so in the applications of human genetic information. The key question is the same – are genes discoveries or inventions? Again the biotechnology companies have argued that making copies of genes allows them to be classed as inventions. There has been very widespread opposition to patenting human genes; some organisations, including in the United Kingdom, the Nuffield Council on Bioethics, have opposed patenting of genes from any source. Gene patenting was also strongly opposed by the Human Genome Organisation21 (HUGO): ‘…the genome is the common heritage of humanity’. Indeed, this stand against gene patenting taken by the non‐profit organisations involved in the Human Genome Project was the cause of significant tension between them and a commercial organisation, Celera Genomics. This company was not part of the public‐ and charity‐funded HGP consortium but having reviewed the commercial potential in the use of human gene sequences had purchased 300 DNA sequencing machines22 and had sequenced at least part of most human genes by the time that the HGP consortium was ready to announce the first draft of the sequence. It had been the company’s intention to patent these sequences but HUGO and the HGP consortium were determined that as many of the sequences as possible should be in the public domain and indeed had been placing each newly determined sequence in the public databases. The point was well made by Professor Bartha Knoppers, at the time HUGO’s chair of ethics, stating, in relation to the application of our knowledge of human genes: ‘In the interests of human solidarity, we owe each other a share in common goods, such as health’.
However, as we made clear in Chapter 6, human gene sequencing was under way before the HGP was initiated and even during the project significant activity in human gene sequencing took place outside of the HGP consortium. Inevitably then, given both the commercial interest and the interpretation of the patenting criteria by the US patent office, thousands of human DNA sequences have now been patented. There is clear evidence that for genes that are already useful for genetic diagnosis and testing, patenting has affected the availability of the tests. Examples of this are the BRCA 1 and BRCA 2 genes, mutations of which give a very high lifetime probability of contracting breast and/or ovarian cancer. All the relevant data indicate that tests involving these sequences are more expensive than they would have been had the genes not been patented. This has implications for access, whether healthcare is provided through insurance (if costs increase, then premiums may have to follow) or as part of the social wage, as, for example, in the UK’s National Health Service (there may be questions of priorities in relation to spending a defined budget). And above all it has implications for the less‐developed countries of the world, especially sub‐Saharan Africa. Average life expectancy in many African countries is still less than 40 years; childhood dysenteric diseases and malaria are still major killers and HIV/AIDS is rife. If gene‐based treatments do turn out to be useful in Africa, surely the need to pay increased costs due to patent protection would be impossible, as it proved with the anti‐HIV drugs prior to the completion of negotiations on generic versions. Other cases where problems arise from gene patenting will surely follow and the arguments will go on.
However, a relatively recent ruling by the US Department of Justice (USDJ) may change all this. It is widely thought that President Obama (who has a background in law) opposed the patenting of genes; this may be the reason for the review of the practice by the USDJ.23 In 2010 they stated that ‘Common sense would suggest that a product of nature is not transformed into a human‐made invention merely by isolating it’, although they do concede that ‘DNA sequences that have been manipulated in some way should be patentable’. In the same year, the New York federal district court ruled as invalid several claims in patents governing the use of the breast cancer genes BRCA1 and BRCA2 for genetic testing. The case had arisen from a challenge to the patents made by a group of organisations, including patient support groups.
The USDJ’s position was challenged by Jim Greenwood, president and chief executive of the US Biotechnology Industry Organization: ‘If adopted, the Department of Justice’s position would undermine US global leadership and investment in the life sciences’ – a statement that clearly reveals the motivation for patenting of genes. In the meantime, Myriad Genetics of Utah who owned the patents on BRCA1 and BRCA2, appealed against the decision of the New York court. Indeed, the Myriad case went through several appeals and counter‐appeals but eventually, in a ruling by the US Supreme Court, the company lost. Echoing the USDJ, the Supreme Court stated, ‘A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated’. This effectively invalidated Myriad’s patents. However, as with the USDJ, the Supreme Court also stated that ‘manipulation of a gene to create something not found in nature could still be eligible for patent protection’.
Gene patenting thus still remains a controversial and in some ways a complex issue. We therefore close this section with the following:
The word piracy conjures up a picture of a bygone age: robbery at sea carried out by sailors brandishing cutlasses and wearing high boots and striped jerseys. It even has a slightly romantic image. However, it was not and still is not a romantic activity. Robbery at sea is still robbery. In those bygone times pirates were very much feared and even today in some parts of the world, piracy is still a hazard, albeit not as frequent as in previous centuries. So what has piracy to do with genes? Can genes be the subject of a robbery at sea? To unpack this we need to note that that the term has gained other meanings since the 16th and 17th centuries. Those meanings centre around using something without permission such as running a radio station without proper authorisation (‘pirate radio’), infringement of copyright (as in the pirating of DVDs) or the infringement of another’s business rights. Gene piracy embodies the concept of using genes (perhaps for commercial advantage) without permission. The latter would include infringing the patents granted on genes (see Section 11.3).
However, we need to widen the discussion. Consider the following case:
This may seem far‐fetched but it is loosely based on a real case in the United States. Is it genetic piracy? It certainly appears so on the surface. The patient’s cells, for the sake of the genetic lesion they exhibit, have certainly been used without the patient’s permission and in a way that brought gain to the users. Let us attempt to dissect the case a little further. In terms of medical ethics, removal of the spleen was an act of doing good – beneficence. The slight inconvenience of living without a spleen was significantly less than the threat to the man’s health had the spleen not been removed. Nevertheless we suppose that the patient’s personal autonomy had been respected in that he could have refused surgery had he wished. After surgery it was assumed that the patient had no more need for his spleen; indeed, it was for the sake of his health that it had been removed. Once outside his body, those involved deemed that he no longer had jurisdiction over it. In the real case, which involved a patient with hairy cell leukaemia, the patient sued the doctor and the university hospital but he lost.24 It was argued that, having given permission for the spleen to be removed, he no longer had any ownership rights to it. We may argue that the action of a virtuous person would have been to at least inform the patient as to what was intended and, more virtuous still, to have asked permission. We may feel uncomfortable that an injustice has been done; we may also think that the patent on the cell line should not have been granted (but see Section 11.3). However, the law was not broken.25
In the United Kingdom there is great sensitivity concerning the fate of organs removed, for example, during autopsy examinations. This follows some high‐profile cases concerning at least two major hospitals where organs removed from children who had died were kept by pathologists without seeking permission from the parents. Under more recent and clearer legislation (The Human Tissue Act, 2004), if there is no pre‐death consent of the deceased, next of kin’s permission must be obtained to retain any organs from dead bodies (including organs needed for transplant) or to do any post‐mortem research. Specific permission must also be obtained to use patients as subjects in research projects. However, as in the United States, it appears that once an organ has been removed during surgery, it no longer belongs to the patient, even if some like to keep their appendix or a diseased kidney in a jar in their office (and in any case, what exactly is meant by ownership of our bodies or their constituent organs is not very clear). Let us however imagine that permission was needed to use such an organ for research, would the ‘donor’ have any claim on income gained as a result of that research? Again the answer is No. The situation would be similar to that of, for example, the live donor of the kidney: he or she has no call on any income that the recipient earns in the extra years that they gain. Anyone who donates a kidney makes a gift,26 not an investment on the recipient.
In the case just discussed, things were not what they initially seemed. What about the following?
Here, the key questions again relate to ownership. Firstly, in what sense can the indigenous people of the country be said to own the knowledge that certain plants help with inflammation and pain relief? Is this ‘intellectual property’ in the sense that we normally understand it in the commercial intercourse of developed countries? The answer to this is almost certainly ‘No’. Folklore and traditional indigenous knowledge do not sit comfortably with our systems for defining intellectual property and, in that sense, the scientists may argue that they were taking from no one. Secondly, what of the plants themselves? Do wild plants belong to anyone? Certainly in many developed countries, there are laws preventing removal of plants from privately owned land but this was not the case in the present study. Further, the United Kingdom and certain other countries also have laws forbidding the removal of wild plants from their natural habitat, except under well‐defined circumstances. It is highly unlikely that the South American country in question had such laws. Presuming that the plants in question were not endangered species and that the returning scientists paid attention to the plant hygiene regulations in force in their own country, it is difficult to establish that they have taken anything that they should not have done. In some respects they were like those earlier generations of plant hunters who returned from distant shores with exotic plants that are now commonplace in our gardens, conservatories and greenhouses.
It thus appears at first sight that our scientists had done nothing illegal in bringing back these plants and in initiating a research and development programme that will lead to the registration of intellectual property in the form of patents and eventually to profits for the company, with no obligation to the country from which the plants were obtained. If this is piracy, who has been robbed, whose intellectual property has been used without permission? One case that is widely quoted is the development by the major US pharmaceutical company, Eli Lilley, of the anticancer drugs, vincristine and vinblastine, obtained from the Madagascar or rosy periwinkle, Catharanthus roseus (previously known as Vinca rosea). These have been both a medical and a commercial success but the people of Madagascar have not reaped any financial benefit from this.
We suspect that many of our readers feel uncomfortable about this and will at least have had the reaction that it is ‘not fair’. Surely, some will argue, the action of a virtuous person or even a virtuous organisation would be to reward in some way the indigenous people on whose folk medicine the new drug is based, or if not the indigenous people, maybe the country at large could benefit. They may state this even more strongly when it is realised that in the search for new plant‐derived drugs, surveys that focus on plants used in traditional medicine have been much more effective in yielding interesting compounds than more random surveys. But it remains clear that Eli Lilley did not break the law of any country in exploiting the Madagascan (rosy) periwinkle.
However, there are other versions of this story that illustrate how difficult it is to assign rights and royalties. The main points, for example, as presented by Michael F. Brown,27 are as follows:
Botanists disagree as to whether the plant was once confined to Madagascar or was simply first described there. It is now a very cosmopolitan species, growing on all continents except Antarctica. Seeds were distributed among Europe’s botanic gardens as long ago as the 1700s and it had a wide range well before the Industrial Revolution. Extracts of the leaves have been extensively used (not just in Madagascar) as a folk remedy for diabetes, not cancer. How effective this was is a matter for conjecture but Eli Lilly’s interest in the plant was certainly first associated with diabetes. The company obtained its first batch of plants from India and later from Jamaica. As is now well known, the search for compounds active against diabetes was not successful; instead the company obtained very small amounts of the anticancer alkaloid, vincristine. Around the same time, a team at the University of Western Ontario discovered another anticancer alkaloid, vinblastine. These were not associated with any of the medicinal folk knowledge surrounding C. roseus (i.e. they had nothing to do with diabetes). The two research teams collaborated and in order to obtain enough material to make extraction of the alkaloids worthwhile, large quantities of leaves were bought from a ranch in Texas. After the required clinical trials had been completed, Eli Lilly put the drugs on the market in the 1960s. As Brown writes, ‘Given this complex background, it is hard to insist that Madagascar must enjoy special standing in discussions of profits generated by the rosy periwinkle’s biochemistry’.
Whatever the rights and wrongs of the rosy periwinkle story, the international community has moved to address imbalances of power between the richer and the poorer nations. Firstly, the 1992 Convention on Biological Diversity (often called the Rio Declaration) gave each sovereign state the rights over the biodiversity existing within that state. This includes the right to exploit commercially any living organism or any ecological community and some applications of that right may in fact have deleterious effects on biodiversity (see also Chapter 14). In the case presented in the current study, the country in question would be able to force the company to enter into a specific agreement, perhaps allowing exploitation of any medicinal plants, in return for a generous share of any income that arises. Thus, Costa Rica, in Central America, has entered into an agreement with a transnational biotechnology company, enabling the company to exploit the gene pool of the country’s rainforest under these terms.28 It is in the company’s interest to protect their asset and thus to investigate the commercial potential of forests plants without destruction of this unique habitat. Overall, some commentators have suggested that agreements such as this might create a genuine commercial flow of money from the richer to some of the poorer nations. Secondly, the Rio Declaration recognises the wealth of local knowledge on biodiversity held by indigenous people. In respect of medicinal plants alone, it is estimated that somewhere between 25,000 and 75,000 plant species are or have been used in traditional medicine. As we have already noted, this folklore‐based knowledge is not entirely compatible with more conventional approaches to intellectual property. However, the international community, acting through the World Intellectual Property Organisation,29 is working to bring local genetic resources (GRs), traditional knowledge (TK) and traditional cultural expressions (TCE – music, dance, art, etc.) under an extended intellectual property umbrella. Thus in 2010, the Nagoya protocol was established, requiring that commercial organisations obtain the written consent of local or indigenous people before exploring their region’s GRs or making use of their traditional know‐how. This has in many cases ensured that indigenous peoples reap some reward, via internationally recognised mechanisms, if their knowledge is exploited commercially.
Overall then it appears that an imbalance of power is being corrected within this general area of exploiting ‘exotic’ gene pools. Nevertheless, unrewarded exploitation still occurs, mainly because of what the EU has called the vested interests of powerful companies in the developed nations of the North: 90% of GRs relating to drug discovery are in the South and 90% of the patents are in the North. For example, in 2000, the German company Schwabe patented (and made significant profits from) a drug derived from Pelargonium sidoides, a plant that has been used by indigenous communities in South Africa for centuries to treat respiratory diseases. The patents also claimed exclusive rights to the medical use of the plant. Neither the indigenous communities nor the Republic of South Africa were compensated in any way. However, in 2010 the African Centre for Biosafety (based in South Africa) and the Berne Declaration30 appealed against the granting of the patents, calling them ‘an illegitimate and illegal monopolisation of genetic resources derived from traditional knowledge and a stark opposition to the convention on biodiversity’. The appeal was successful and the patents were cancelled. Because of this and a handful of similar cases, the EU has enacted legislation (regulation 511/2014) that further strengthens the rights of indigenous people in relation to patents and other forms of intellectual property in Europe.
We move from the rights of indigenous peoples to a topic that is very much the product of modern molecular biology. The invention of DNA fingerprinting techniques is one of those events showing that science frequently does not progress according to the ‘formula’ presented by some science philosophers (see Chapter 1). In 1984, at the University of Leicester in the United Kingdom, Dr Alec Jeffreys (now Professor Sir Alec Jeffreys) was studying patterns of inheritance of genetic diseases in humans. He and his team had devised an experiment for tracing a particular type of repeated DNA through family lineages. However, the experiment did not work out as they expected. Instead, it became obvious that the ‘barcode’ produced by the experiment, with each bar representing a particular number of DNA repeats, was unique for each individual (unless, as they later showed, an individual had an identical twin). Individuals could thus be identified with precision from their DNA barcodes or DNA fingerprints as they quickly became known. Further, the DNA fingerprint could also be used to established kinship: for example, the pattern of bands in DNA from one of the research technicians could be seen to be a hybrid of her mother’s and her father’s DNA banding patterns. Jeffreys describes the discovery thus: It was an absolute Eureka moment. It was a blinding flash. In five golden minutes, my research career went whizzing off in a completely new direction.31 In an interview in May 2016, he said that the new direction lasted 20 years, after which he came back to his ‘first love’ in genetics, the inheritance of genetic disease. And, although most scientists do not enter the profession in search of fame and fortune, those have come his way, with a knighthood and many other awards, including being named in 1989, Midlander of the Year32 (the award that most amuses him).
The first ‘real‐life’ application of DNA fingerprinting came in 1985. Lawyers were fighting against the deportation of a young boy whom the Home Office stated was not, as had been claimed, the son of a British woman and on that basis had no right to British nationality. The lawyers got in touch with Jeffreys to see if his new discovery could help – and it did. DNA fingerprinting showed clearly that the boy was indeed the son of the woman in question and the Home Office dropped the case. Between 1985 and 1995, DNA fingerprinting (or DNA profiling: see below) was used with 18,000 immigrants who had been refused entry into the United Kingdom. The tests showed that over 95% of these were blood relatives of UK citizens and were therefore entitled to British citizenship. DNA fingerprinting is thus a powerful tool in elucidating family relationships, not only in immigration (and similar) cases but also in domestic disputes about paternity. Using the words ‘DNA testing’ as a search term will bring up scores of references to companies that provide DNA testing for paternity or family relationships. Further, this is not confined to humans. DNA fingerprinting has also been used to settle disputes about the paternity of thoroughbred racing greyhounds and race horses.
However, in the public mind, DNA fingerprinting is most often associated with its forensic use. The first instance of this started in late 1986 when two teenaged girls were raped and murdered in a village near Leicester. A man had confessed to one rape/murder, but not to the other. DNA fingerprinting showed two things. Firstly, the man who had confessed to one murder had not done it (his motivation for confessing remains unclear). Secondly, both rapes/murders had been committed by the same man. After obtaining DNA samples from every man in the area, the real killer was identified and brought to trial.33 We need to add that although it sounds very straightforward, it was not. Solving the case involved both science and a great deal of ‘good old‐fashioned detective work’.
From this point, the technique was used in many more cases in which a biological sample of some sort had been left at the scene of the crime. Techniques for extracting and amplifying DNA have become more sophisticated and DNA sequences different from those originally used are now employed. The patterns provided by these sequences are known as DNA profiles and are readily digitised for storage in DNA databases (see below). Many thousands of crimes have now been solved and many thousands of paternity cases have been settled throughout the world through use of DNA profiling and its predecessor, DNA fingerprinting. Dead persons, including the very long‐dead English King Richard III34, have been identified. There has even been a recent case in the United Kingdom in which DNA testing has been used to establish a person’s right to a hereditary Scottish title.
All these seem to be a very good uses of science on behalf of wider society and in the main they are. However, as indicated by the second quotation at the head of this chapter, there may also be problems. In 2005, a taxi driver, David Butler, was arrested, held in prison for eight months and tried for murder (but thankfully acquitted) because DNA on the hands of a murdered woman matched his DNA profile held on a police database. The problem arose because the police relied solely on DNA evidence; there was no attempt to find out whether the suspect had a strong alibi – he did and, indeed, could not have been present at the scene of the murder at the appropriate time – nor to think of other possible reasons for the presence of his DNA on the body of the murdered woman. The latter became clear when we consider Butler’s work as a taxi driver. The woman had ridden in his taxi and money had changed hands at the end of the ride. Further, he suffers from a skin condition in which flakes of skin are shed at a much higher rate than average, making a hand‐to‐hand DNA transfer very likely. In other words, reliance on only the DNA profile had meant that the police had not attempted to get the ‘whole picture’ or to do what was described above as ‘good old‐fashioned detective work’. The shortcut followed by the police had resulted in David Butler spending a very unpleasant spell of eight months in prison, followed by a very stressful trial. It is thus very important that in order to avoid miscarriages of justice, the police and the courts do not rely unquestionably on DNA evidence when other evidence points to different conclusions.
In our summary of David Butler’s wrongful arrest in the previous paragraph, it was mentioned that his DNA profile was on a police database. Why was it there? Had he been previously charged with a crime or even found guilty of a crime? The answer is neither of these. His DNA profile was available to the police because it he had willingly given a sample to them during an investigation into a burglary at his mother’s house a few years earlier.
This leads us to consider the topic of national databases for forensic use. Law enforcement authorities in several countries have argued that it would be very helpful in solving crime if everyone’s DNA profile was held on a national database. Any DNA sample obtained from a crime scene could then be compared with the profiles held on the database. In the United Kingdom, for example, DNA‐based evidence has helped to solve about 350,000 crimes since 1998, even without a national database. However, it is a controversial topic which has been dealt with differently in different countries. At the time of writing, UK police forces held the DNA profiles of more people than in any other country and our discussion here relates mainly to the United Kingdom.
In order to think about this from a bioethical standpoint, it is important to define our terms. By DNA profile we are referring to the digital record of the particular repetitive DNA sequences used as described above (although in some cases, the DNA itself is also kept). We are not talking here of complete genome sequences (which may have a role in medicine and which have their own bioethical implications – see Chapter 6). The profiles thus have a limited application but nevertheless are more or less specific for each individual. Thus with the sequences used for DNA profiling in the United Kingdom, the probability of a match between two profiles by chance is one in a billion (1 in 109). It had been the practice of UK police forces to take DNA samples from anyone, including juveniles, who had been arrested (except for motoring offences), whether or not the arrest led to a successful charge and to keep the profiles on file indefinitely. Also kept on file were the DNA profiles from volunteers who had given DNA samples to help police to solve crimes (as mentioned above) and profiles from DNA samples obtained from crime scenes. For the latter, the DNA itself may also be stored as a backup to the digitised profile. In past cases this has proved useful in that, with the improvement of techniques for DNA analysis, old cases have been reopened and solved.
In fact, a number of criticisms have been made of the use of DNA databases. Some of them relate to the technology itself and some to the possible misuse of databases. Eventually in the United Kingdom, the practice was challenged in the courts and in 2008 the challenge reached the European Court of Human Rights. The Court found in favour of the plaintiffs and therefore against the United Kingdom. The judgement was very clear: ‘…the blanket retention of DNA profiles taken from innocent people posed a disproportionate interference with the right to private life, in violation of Article 8 of the European Convention on Human Rights’. This led to changes in practices related to forensic DNA databases, changes that were embodied in the 2012 Protection of Freedoms Act.
In one of the quotations at the head of this chapter, Peter Moore urges us to ‘make use of genetics and not let it make use of us’. What this chapter has shown us is that the balance between these alternatives is hard to achieve and that this difficulty applies right across the board from exploitation of ‘traditional’ knowledge (which is essentially genetic) to the use of people’s personal genetic data in DNA fingerprint or in full sequence databases. Appropriate use of genetic knowledge requires an understanding of what, at any one time, is possible, coupled with an ability to perceive the ethical and social issues (but without exaggerating or over‐playing these). The examples in this chapter show that indeed this challenge can be met: we can avoid genetics ‘making use’ of us.