Section 4: The Bioethics Council's thinking

The use of human genes in other organisms clearly raises cultural, ethical and spiritual concerns for many people. The nature of these concerns is more complex and nuanced than a simple acceptance or rejection of their use. The Council recognises - and welcomes - the community's embracing of an understanding of both social and biological life (and the associated ethics) as emerging from a set of complex interactions.

In this section we build on the experience from the public dialogue and the Council's own work to:

• note the present and possible uses of human genes, and the questions they raise
• explore the cultural and ethical significance of 'human genes', which is additional to their scientific significance
• identify some emerging issues related to the use of human genes
• examine the importance of discussions on the relationships between science and commerce.

In the final section we discuss the contribution of dialogue to community understanding of the cultural, ethical and spiritual dimensions of biotechnology.

What the science can do, and the decisions that face us

[In the following discussion we refer to a number of concepts and procedures of a fairly technical nature on the basis that this material has been covered in previous publications. Those wishing to access more information should visit the Council's website.]

The use of human genes in other organisms is about more than the transfer of a single gene and its associated regulatory regions.

The standard purpose of genetic technology using human genes in other organisms is to produce a protein in the host organism that is usually produced in a human. There are two main ways to achieve this:

• isolate and copy the DNA that makes up the gene
• isolate the RNA, which is the intermediary between DNA and protein, and from that make cDNA (which differs from the original DNA in usually being shorter, with introns removed).

The DNA or cDNA is then either inserted and cloned (copied) in bacteria, or copied using the polymerase chain reaction (PCR).

Considerable changes are made to the gene before it is inserted in the host organism. Associated regulatory sequences may be altered, or the DNA sequence of the gene of interest changed. The resulting protein will be the same, but the host organism may be able to express it more effectively or efficiently.

Increasingly, there is another way to produce human proteins in other organisms that does not require any direct physical connection to the human gene. Researchers can predict from the chemistry of the desired protein (and by reference to computer databases) what DNA sequences will produce that protein, and, of these options, which one will do it most effectively in the host organism. This cDNA sequence can then be created in a test tube and inserted into the host, which will then produce a human protein.

As the potential applications of genetic modification expand, the technology may involve single or multiple genes. The host organism may be a bacterium, a plant or animal cell line, or a living plant or animal.

The modified organism may, as a result of the modification, produce a product (e.g., recombinant factor VIII) that can be used for medical or industrial purposes. Or it might produce an organism with characteristics of interest in research (e.g., a mouse that expresses a medical condition thought to parallel a disease in humans). The research may be directly medical or applied - but need not be. It may be seeking an understanding of how particular genes work. For example, by using human genes in rhesus monkeys it might be possible to understand how particular genes contribute to aspects of reproduction or development, or the function of genes associated with human speech.

There are parallels here to other work that is broadly accepted. Humans have long bred organisms to make them more useful to humans, and in science used them in various forms of research (medical, pest management, behavioural studies or agricultural production). This has included teaching chimpanzees to use sign language and hence to acquire skills usually associated with humanness.

There are also points of difference: in particular, the intervention is at the molecular rather than whole-organism level. What is crucial - and a matter for discussion - is the cultural and ethical significance of such points of difference, and how these might interact with the values that are important to the New Zealand community (see Section 3).

The significance of the 'human gene'

In strictly scientific terms it is difficult to sustain any distinction between a human gene and those from other organisms. All genes are made of the same chemical material (bases), and many human genes have the same or a very similar sequence of bases to those found in organisms ranging from flatworms to chimps. In addition the versions of human genes used in genetic modification are copies or imitations - not originals - and are often versions that have been significantly modified by deletion or alternation of some sections of DNA or the addition of different regulatory sequences.

However, genes are more than chemicals. They also have cultural significance. They have become symbols or conveyors of that which we have inherited from our ancestors. They have become symbols of the relationships we have with each other and with other forms of life. The DNA of which genes are made has become a cultural icon with a range of meanings to different people: the book of life, a sign of our origins, information about our identity, and an indicator of our future. Genes now carry some of the associations that have been traditionally linked to such things as lineage, blood, whakapapa or creation, as well as having associations with more reductive understandings of life as being like a machine or programme.

Currently there is a concern among some that human genes should not enter the food chain. While for some the concern is related to risk, there is also a cultural issue in that it is inappropriate that human genes be in food. We consider that this opinion should be respected.

It is therefore not surprising that for many people there are considerations about the use of human genes in other organisms that are additional to those associated with genetic modification per se. The use of human genes - even a single human gene - is not something to be done lightly or casually. Decisions need to take account of the various issues in addition to an immediate risk assessment. The context matters, not only for scientific understanding but also for social significance. Indeed, the purpose of the genetic modification matters, especially when human genes are being used, but the consequences for the host organism are also significant.

The significance of being human

How we use human genes, and the purposes to which they are put, says something about what it means to be human, how we express respect for humanness, and what is special about humans. This is in contrast to one scientific understanding of genetics that we are the same as other organisms. It is therefore important that our use of human genes in other organisms expresses and responds to what is important to the community about being human, and the relationships through which we express this.

The Council holds the view that it is not the use of human genes per se that is the issue. Rather, what is important is how our use of human genes demonstrates respect for what is special about human life, and our relationships with each other and with the rest of biological world. Humans are both 'just another organism' and an organism to which we give special significance. Humans express that special nature of the human body (of which genes are just one expression) [But so also will be cells, gametes, embryos, tissues and organs. Schedule One, Prohibited Actions in The Human Assisted Reproductive Technology Bill 2004 bans the development of in vitro or hybrid embryos.] in part through the protocols, social norms, tikanga, and scientific practices around the use of human genes.

Ethics is about how we give expression to our values, including how we manage the technologies that are available. The social practices humans develop, and the values that inform our choices, reflect our interpretation of the wider social and biological context, our learnings from past experience with technology, and the account we take of the potential for biotechnologies to disrupt or contribute positively to social and environmental relationships.

Maori called for respect for wairua (spirit), mauri (life-force), hinengaro (mind), tinana (body) and mana ake ma wairua (influence over spirit) when progressing future sciences.

Such protocols, norms and practices may well change over time, but this is no reason to diminish their current importance.

In addition, we wish to highlight two areas where we think additional ethical concerns remain, both associated with the genetic modification of animals:

• the limits on the type of acceptable genetic modifications
• the ethical review of research that creates genetically modified animals for the purpose of research or production.

Limits on genetic modifications involving human genes

There are certain types of modification to which the Council is unconditionally opposed.

The Council opposes, most notably, those modifications that would give non-human organisms the capacity for human language, and associated powers of reason, and those that would cause non-human organisms to look like humans. These types of modification of non-human organisms are unacceptable over and above any suffering or discomfort they might cause the organism, or any general caution about the use of human genes described in the preceding section and recommendation.

Consider, by contrast, a genetic modification that would make an animal develop a specifically human disease that would aid the development of a treatment or cure. In accordance with its other recommendations, the Council would urge caution, and a careful weighing of likely benefits against costs, but it would not necessarily oppose such a modification.

At this stage, the particular modifications the Council is here opposing are not possible and it is only relatively recently that they have become even reasonable to consider. It is consequently unsurprising that it is not yet entirely clear how we, as a society, should respond to such modifications. One point the Council wishes to make is that the questions of the ethics of hybrids requires more thought and that its recommendations are not intended to be the final word. Furthermore, the sheer novelty of this topic explains why the Council, like many of those in the dialogue process, are clearer about which modifications are unacceptable than about the underlying reasons.

That said, the Council holds that part of the reason it is unacceptable to modify non-human organisms so that they speak, think, or look like us is because these changes might well (and perhaps should) affect the moral status we ascribe to these modified non-human organisms and in ways that we cannot predict.

The ethical review of research that creates genetically modified animals for the purpose of research or production

Although the ethical aspects of our relationships with other organisms are not confined to issues of animal suffering (see below), these are still important.

In relation to the use of human genes in other organisms, there is ongoing discussion about the acceptability of the use of animals in research, most often focused on the burden of suffering animals experience. Any research with sentient animals will continue to require an ethical judgement about whether the suffering of the animal is sufficiently justified by the nature of the benefits from the research.

The genetic modification of animals with 'human genes' to provide animal models for human disease has created a new dimension to this research (as do any other interventions early in gestation or development). Research is deliberately creating animal lines that could carry a significant burden of suffering as a result of the modification, quite apart from any intervention the animal will experience once born.

At present this dimension of animal ethics falls outside the scope of animal ethics review, which only considers the welfare of the organism that is the source of any gametes or embryos that are genetically modified, or the ethics of interventions once a mammalian foetus, or any avian or reptilian pre-hatched young, is more than halfway through the gestation period.

Yet the use of human genes in an animal to create an organism that can act as a 'model' for a human disease has the potential to develop an organism that will carry a significant burden of suffering, independently of and additional to any subsequent research. The Council holds the view that such interventions, where they will lead to organisms developing past the first half of gestation or development, and/or being born, should be subject to ethical review.

The Bioethics Council recognises that further public dialogue is needed about the appropriate balancing of animal welfare and the benefits to medical science from the use of animals genetically modified to be models of human disease or a source of tissue for human medical treatment.

Human relationships with other organisms

Our use of human genes in other organisms reflects views of the relationships humans have with particular organisms. These relationships are complex, particularly with respect to animals.

The conversations in this area are difficult and will be on-going, beyond any discussion of the use of human genes in other organisms. Some of the important dimensions of these conversations are:

• the dependence of humans on sustainable ecosystems
• the value many in New Zealand give to ecosystems and the species within them, whether or not those ecosystems or species having immediate utilitarian value
• the historical relationships with some organisms, which have led to changes in the characteristics of some species (e.g., rice, wheat, cows, dogs)
• the 'companion' status of some animals for some people
• the historical use of animals in research, and the burden of suffering associated with some research
• changes in attitudes to animal suffering in recent years
• the various benefits (including food and research) derived from the use of animals.

The concerns about relationships with other organisms are not only about animal suffering. They are also about the wider relationships and interconnectedness of life forms. For instance, some plants have a particular value or significance (e.g., for cultural and/or food reasons), which would make some uses of genetic modification unacceptable.

Dealing with emerging biotechnologies

In the course of this project the Bioethics Council has become aware of a number of emerging issues in biotechnology that will raise similar ethical issues.

There is international research involving interventions such as the transplantation of human stem cells into non-human embryos or foetuses, or the creation of human-animal embryos. This research, like some uses of human genes in other organisms, involves the transplant of human material into other animals. There is the potential for considerable medical benefits from such research, but there are also concerns about the appropriate uses of such technologies, both for making animals more 'human-like' in culturally significant ways, or producing live animals that carry an unacceptable burden of suffering.

Such developments were almost unthinkable only a few years ago, but are rapidly moving into the 'routine research' category. This illustrates the speed with which new developments in biotechnology emerge (additional to those raised by genetic modification), that may involve cultural, ethical and spiritual issues.

It is difficult to predict the timing or nature of these issues as they emerge, but it is important that the Government have a mechanism available to it for when such a situation emerges. Such a mechanism would be important to the wider community, to researchers and to business in order that the cultural, ethical and spiritual dimension of any such developments be explored at an early stage in their developments, and that timely decisions can be made about what regulations, if any are required.

This needs to be additional to the mechanisms currently available in the HSNO legislation,[Hazardous Substances and New Organisms Act 1996.] as some developments in biotechnology (in research as well as in applied areas such as medical or agricultural fields) may fall outside the jurisdiction of that or other legislation, such as the Tissues Act or HART Bill (e.g., the transfer of neural stem cells into animals). [Schedule One, Prohibited Actions of the Human Assisted Reproductive Technology Bill 2004 bans the development of in vitro or hybrid embryos.]

The commercialisation of science

There is considerable tension between the value the public places on independent science for the common good and certain commercial developments in science. A long-standing tradition of science as the disinterested pursuit of knowledge continues to be valued by many - both scientists and the general public.

Alongside this there appears to be recognition that publicly funded research should be available to farmers and other business people. The pragmatic benefits of research are valued, and many people acknowledge that some products will simply not be available without private investment and associated profit. Many are aware of the tensions between benefits to the New Zealand economy and individuals, and benefits going off-shore; and of the potential for New Zealand access to the benefits of biotechnology to be vulnerable to the choices of trans-national businesses.

Claims of enormous benefits of biotechnology to the poor and hungry are frequently dismissed as cynical public relations. While we heard only a few comments at all mistrustful of scientists per se, there was a strong theme of mistrust of the cooperation between science and business interests.

Whatever the actual situation, such tensions have the potential to undermine public confidence in the practice of science, and in the potential of science to deliver economic benefits to New Zealand and New Zealanders.

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