Speeches

A SCIENTIFIC REVOLUTION

Lawyers will only be able to respond efficiently if they are aware of the developments which are occurring and if they familiarise themselves with at least the rudiments of the science and technology which those developments reflect. Here's the rub. So rapid are the advances and so sophisticated and complex are the details of the science and the explanation of the technology, that even an informed lay person finds it difficult today to comprehend exactly what is occurring. I recently attended in Brisbane the annual meeting of the Human Genome Organisation. Its opening keynote address was delivered by Dr Craig Venter, one of the world's leading experts in the sequencing of human genes. I understood about ten percent of what he was saying. Perhaps lay people attending legal conferences feel much the same. But I was reassured to find that many of the scientists present were in much the same boat as I was. Inescapably, genetics, and the technology that has grown to respond to scientific advances, have jumped ahead of ordinary human comprehension. Yet the outcomes of genetics are vital to our society, its democratic institutions, its laws and even to the human species itself. These are not, therefore, issues that can be left to scientists alone.

An indication that lawyers are beginning to wake up to the great significance for their discipline of the revolution in human genetics is found in a recent special issue of the Modern Law Review, published in Britain². Instead of the usual fare of problems in the law of negligence, public law and statute law, ten essays are presented which review some of the major implications of the genetic revolution for the legal discipline, both internationally and nationally.

Specific legal topics identified in the Modern Law Review include (1) how regulation will be possible in the fast moving genetic revolution³; (2) what are its implications for human dignity and human rights⁴; (3) should the law condone interventions in the human genome which alter the genetics of living persons and future generations⁵; (4) what will be the implications of these developments for family law⁶; (5) what consequences will they present for insurance, given the potential of genetic data to remove entirely predictive doubts about an insured's likely health prognosis⁷; (6) will the criminal law need to be revised in so far as it posits the free will of the individual? If the conduct of some persons stems from their genes, should this be exculpation, a defence or at least mitigation⁸?; and (7) how will intellectual property law apply to genetic discoveries? Should scientists, and those who support them, be entitled to the protection of patents in respect of their work or is the genome and its incidents an inalienable part of the common heritage of humanity so that, however temporarily, it cannot be "owned" or "controlled" by any person or corporation however big their investments?

These subjects give a clue as to a number of the principal issues which lawyers now, and in the future, will have to examine as the genetic revolution continues to unfold. In Britain, the former Conservative government established the Human Genetics Advisory Commission. It is a high powered affair. One of the first essays in the Modern Law Review is by Sir Colin Campbell, Chairman of the Commission. He describes the way in which the Commission is obliged, under its terms of reference, to keep under review scientific progress at the frontiers of human genetics; to report to government and society on issues arising from the new developments that can be expected to have wider social, ethical and economic consequences; and to advise on ways to build public confidence in, and understanding of, the new genetics⁹. Sir Colin describes the endeavour to bring the complex issues to a wide audience in Britain and to ensure that the Commission's advice will mirror the broad range of opinion which these complex and sensitive questions evoke.

There is no such body in Australia. The closest we get to it is the Australian Medical Health Ethics Committee which is chaired by Professor Donald ChaLmers of the Law School of the University of Tasmania. There is insufficient public debate in Australia about the genetic revolution. Most people, including politicians, opinion leaders and the overwhelming bulk of the legal profession, must depend upon articles in the popular media for the rudiments of their knowledge¹⁰. Inevitably, such articles tend to concentrate on highly contentious and sometimes sensational issues such as the potential for reproductive cloning of a human being. The full picture is much more complicated. Before embarking on a few of the legal themes, let me sketch, as briefly as I can, some of the general scientific background which it is essential to know.

A SCIENTIFIC PRIMER

This article was not, of course, the first step on the path of genetics. Even in primitive societies farmers knew the benefits of mating particular domestic animals or cross-breeding particular crops. In 1866 the Austrian botanist and monk Grigor Mendel described the basic laws of hereditary based on his experiments with cross-breeding of pea plants. His findings, published in a local journal, were at first ignored. Early this century biologists experimented with the fruit fly to reveal that some genetically determined traits were linked to the particular sex of the fly. These experiments suggested that inherited traits could reside on chromosomes, tiny threads within the nucleus of cells that appeared to be constantly dividing.

The early, primitive discoveries came together, and were explained, by Watson and Crick. They proposed that the basic determinates of living matter were to be found in DNA, in a structure described as a double helix. DNA was the molecule which carried the genetic code that would unlock the truth known instinctively by farmers and described in a primitive, but accurate, way by Mendel. From that moment to this, the search has been undertaken to explore the DNA and to unlock its remaining secrets.

The coincidental development of information technology, which in large part had grown out of defence operations and miniaturisation required for the space race (in their turn propelled by nuclear rivalry) presented the technology which would help scientists to perform the analysis necessary to understand the control mechanisms residing in the DNA. In 1990 a group of scientists decided that they should cooperate in sequencing the entire human genome. The genome represents the complete set of genes and chromosomes of the organism. The intention of this project, which became known as the Human Genome Project, was to construct a "high-resolution genetic, physical and transcript map" of the human being with, ultimately, a complete sequence of the genome. The outcome is the largest research project ever undertaken. The object was to determine the location of the estimated 100,000 human genes. The purpose was to provide "the source book for biomedical science in the 21st century [which would] be of immense benefit to the field of medicine. The object is to understand and eventually treat many of the more than 4,000 genetic diseases that afflict mankind, as well as the many multi-factorial diseases in which genetic predisposition plays an important role"¹².

The 100,000 genes appear in the double strand of DNA which is of enormous length. One scientist¹³attempted to describe to a non-legal audience the dimension of the challenge:

"The DNA content of a human cell, written out in letters, would fill one thousand 1,000-page telephone books. We often speak of that DNA as containing or encoding 100,000 genes. In some way that is a mis-statement of the complexity, because we know that genes are commonly related and fall into families or super families, each having of the order of 10 to 100 members. Therefore, this complexity is actually something of the order of 1,000 to a few thousand different gene structures. Many of the genes in our bodies are alternatively spliced. In the brain the most common protein that I know has already at least 50 different splicing patterns. I think that when we look at the structure of our genes and ask what individual structures will do, what different things, we will find about several million gene variants in the brain and of the order of 100,000 gene variants in the body. Thus, to understand the full complexity of the organism is going to be very difficult. How are we going to find out these details of structure, and specifically how the individual genes determine the individual parts of our bodies? The answer is that we are going to do it by sequencing. Although we will identify a number of genes by mapping and other techniques, ultimately we are going to predict the majority of gene forms from their sequence".

 

Gone will be the uncertain knowledge of Mendel. The reason for inherited traits, including painful, debilitating and also fatal illnesses will become known. Large funds are being devoted, principally in the United States of America but also in Western Europe, Japan and some in Australia, to unravelling the secrets of the human genome. The only analogies which spring to mind in the human imagination are those which concerned the mapping of the earth's surface by the great cartographers of the 15th and 16th centuries and the unravelling of the secrets of the universe by space travel and probes, in our own time. Now, after the enormity of space, we are reaching down into the infinitesimally small elements of life. Life is the particular phenomenon (but not unique) of our planet. The central challenge is to understand the peculiar and distinctive phenomenon of human existence and intelligence.

The human genome existed before Mendel and Watson and Crick. It was always there. But by the intelligence of humanity and with the aid of still further discoveries, it has become possible to unravel some of the secrets of the genome. The larger implications, including whether it will permit a rapid advance of human evolution and the nurturing of "super human beings" and even of a new species, is outside the scope of this paper. Having sketched the science, let me return to some of the basic legal issues which the science presents.

MUNICIPAL LEGAL ISSUES

1. Medical therapies: Scientists are now discovering the genes which "trigger" various genetic diseases which, in turn, constitute a large part of the inherited causes of the suffering of humanity. For example, the genes which express Huntington's Disease, a serious affliction, have been identified on the human genome. Their discovery permits the conduct of extremely accurate tests which can now identify those people who carry and may transmit this genetic condition. That knowledge would, theoretically, in combination with prenatal tests and abortion, permit the future elimination of carriers of Huntingtons. Is this desirable? Can it be distinguished from the abortion of a foetus with Down Syndrome? Where does this process of medical elimination of the results of "defective" genes begin and end? Is there a less life-destructive means of using the genetic information to delay the onset or diminish the symptoms of Huntington's disease whilst respecting the life of a person born with those genes or others like it?

(2) Criminal Law: For the lawyer, the discovery of genetic causes of disorders and of some antisocial conduct may have implications for the future. The criminal law is built upon a general hypothesis of free will. For the crime to be established it is normally necessary to prove both the act of the accused (actus reus) and the will ( mens rea ) occasioning that act. But what are the implications for the law of discovering that, in some cases at least, for some people, the act is practically nothing but the product of a genetic characteristic? Can we persist, in all cases, with the unquestioned hypothesis of free will in the face of scientific knowledge which casts doubt upon it?

(3) Privacy and Confidentiality: The basic rule of the healthcare professions has long been respect for the confidences of the patient. This rule goes back at least to the Hippocratic Oath. It existed in ancient civilisations. But when a disorder is of a genetic characteristic, is the "patient" the individual or the entire family? Does a family in such circumstances have a right to override the wishes of the patient and to secure data about the patient's genes relevant to genetic features important for them all? Should a patient have a right not to know the determinants of his or her future medical conditions?

(4) Third Party Interests: This last question leads to the rights of third parties. Should an employer have a right to require an employee to submit to genetic testing to show, with greater perfection, the likely future health status of the employee? Should an insurer be entitled to secure a detailed genetic profile of the insured? Until now, insurance has generally involved the sharing, within the community, of the risks attached to medical conditions which are largely unpredictable. If such conditions can be predicted with perfect or near perfect accuracy, would that not shift the scales unfairly to the advantage of insurers? Yet, where insurers can require those seeking insurance to submit to old-fashioned medical tests, is it sensible to close off knowledge of the best medical information that may be made available by genetic tests?

(5) Intellectual Property: One of the key issues of genetic research concerns the desirability of permitting the patenting of human genes or their sequences as the basis for future therapeutic applications. Of course, in every country, the patentability of such matter depends upon the terms of the local law on intellectual property protection (patents, copyright etc). That law is itself normally the product of national legislation and is often influenced by international law. At conferences on the genome, strong views are commonly expressed by participants from developing countries and elsewhere about this topic. They urge that the human genome is the common heritage of humanity. That it belongs to the human species as a whole - some say to God - and not to private corporations engaged in research, however potentially beneficial such research may prove to be. They point to the fact that Watson and Crick never attempted to secure the slightest commercial advantage for themselves from their discoveries.

(6) Human Rights: An important element in UNESCO's Universal Declaration on Human rights and the Human Genome, to which I will now turn, is the attempt to reconcile the development of genetic technology and research on the human genome with fundamental human rights and human dignity inhering in every individual. The UNESCO Declaration states in Article 6

"No one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity."
 

 
 
 
 
 

INTERNATIONAL DEVELOPMENTS

The opening provision of the Declaration states that "the human genome underlies the fundamental unity of all members of the human family". It recognises the "inherent dignity and diversity" of every individual¹⁵. There you have, at the outset, the assertion of a paradoxical reality which runs through the movement for universal statements of human freedom. They are global in their application. Yet they are individual in their focus.

The main substantive provisions of the new Declaration insist upon the requirement of rigorous and prior assessment of potential risks and benefits for any research, treatment or diagnosis affecting an individual's genome¹⁶. In every case, the prior free and informed consent of the person concerned must be obtained¹⁷. It is specifically recognised that each individual has the right to decide whether or not to be informed of the results of genetic examination¹⁸. No one is to be subjected to discrimination based on genetic characteristics such as will infringe that person's human rights, fundamental freedoms and human dignity¹⁹. Respect for the confidentiality of genetic data which can be linked with an identifiable person must be protected by law²⁰. Just reparation must be provided for any damage sustained as a result of an intervention affecting a person's genome²¹. In order to protect human rights and fundamental freedoms, limitations on the principles of consent and confidentiality are only permitted where prescribed by law for compelling reasons which themselves conform to the international law of human rights²². No research or application of research concerning the human genome may prevail over respect for human rights, fundamental freedoms and human dignity of the individual or groups of people²³.

Much of the new Declaration is addressed to the responsibilities devolving on researchers to conduct genomic research with meticulous care, caution, intellectual honesty and integrity²⁴and to share research outcomes in a way that fosters intellectual freedom, a prerequisite of scientific progress²⁵. States are urged to provide the framework for the free exercise of research on the human genome with regard to the principles established by the Declaration and so as to safeguard respect for human rights, fundamental freedoms and human dignity and also to protect public health²⁶. The Declaration proposes the establishment in each country of independent multi-disciplinary and pluralistic ethics committees to assess the ethical, legal and social issues raised by research on the human genome and its applications²⁷. There are many provisions for solidarity, international cooperation and promotion of the principles established by the Declaration²⁸. The International Bioethics Committee of UNESCO is given the task of disseminating these principles and promoting the acceptance of the Declaration throughout the world²⁹.

Running through the principles of the new Declaration are basic norms concerned with human freedom. There is a recognition of the intellectual freedom which is the environment in which scientific knowledge can alone move forward. But as with the original Universal Declaration of Human Rights of 1948, most of the core provisions of the Genome Declaration are concerned with the freedom of the individual who may be affected by genetic research, testing or therapy. The dignity, privacy and integrity of that individual are to be upheld. In short, scientific progress should go ahead in the belief that its tendency is not to diminish human freedom but to enhance the benefits to humanity. But it should go ahead in an environment which respects the freedoms of the individuals affected and enhances the freedoms of people everywhere. All people have a right to share in the products of research and applications in biology, genetics and medicine which carry the promise of relieving human beings from suffering and improving the health of individuals and of humankind as a whole³⁰.

THE LAWYERS' APPROACH

The issues which I have outlined in this paper may seem daunting. But they are problems presented to society in our time. Unless our Constitution and laws are to be irrelevant to the major scientific developments of the age, it is necessary for lawyers to respond to such problems. It is also necessary for them to develop the institutions which can respond efficiently and the frameworks within which national responses can be rationally worked out.

Those responses will be founded on a good knowledge of genetic science. They will involve multidisciplinary dialogue such as is achieved in the United Kingdom Commission which Sir Colin Campbell leads. They will require us to think positively as human beings and as lawyers about the potential of genetics to relieve suffering and to save people from premature or unnecessary death. Lawyers will teach their fellow citizens that it is important to choose manageable issues in devising the legal responses and not to wait for a comprehensive response which answers all the problems. No such super response is possible.

The way of the common law involves dealing with practical problems as they present themselves. Take for example the adoption of laws and policies to govern genetic testing. When it may be done? With whose consent? Where the data will go in identifiable form? Issues of this kind are often susceptible to regulation by protocols adopted by the medical profession supplemented, if necessary, by law. Similarly, with insurance. Whether insurers may demand, before accepting a proposal for life or health insurance, the provision of a report on genetic tests of a particular, limited or general character? Such issues may be decided (at least in the first instance) by a voluntary moratorium accepted by insurers, prohibiting the demand for the disclosure of genetic test results in the case of a policy of a certain size; or excluding new genetic tests but requiring the disclosure of those already known to the proponent for insurance³¹. In the long run, the rights of insurers and the obligations of the insured, in relation to genetic data may be governed by law. So far as the results of tests already known are concerned, the universal principle that insurance is a contract of uberrima fides may already require disclosure to the insurer of such information, if it is known by the insured.

Much more difficult of management by the law or by effective voluntary regulation are the deeper questions. Whether genetic data is relevant to the criminal responsibility of an accused convicted of a crime of violence allegedly attributable to genetic predisposition³²? Whether the protections of intellectual property law are apt to the patenting of mere fragments of human genes, such as those known as expressed sequence tags³³. Or whether laws can and should ban both therapeutic and reproductive experiments with cloning involving human biomaterial³⁴? In the first instance, at least, ethics committees and lawmakers will do well to concentrate on manageable, achievable tasks. The larger, more fundamental issues may require time until "the dust has settled and the emotions have been vented"³⁵.

Lawyers will also teach the importance of involving the public in discussion about the legal and ethical choices which genetics presents. On a global level, lawyers will endeavour to explain the difficulties of securing agreement when there are so many different regimes of religious and ethical principles. Thus global prohibitions on experimentation with foetal material are unlikely to succeed. Whereas some Christian groups regard life as beginning at the very instant of conception, Judaism and Islam consider that the embryo does not acquire human characteristics until after 40 days. Other religions and philosophies, and humanists, may choose an even later time. Clearly it is important to develop global institutions and to provide global solutions to a problem which literally concerns all humanity, involved as it is with nothing less than the future makeup of the human species. But the highest common denominator of agreement may not be very high.

CONCLUSIONS

Important ethical and legal challenges are presented. It is vital that the best legal minds should be engaged upon these problems and challenges. They do not only affect wealthy nations in the forefront of genomic research, such as the United States. They do not only affect countries like Australia which contribute to that research and which will benefit from the medical therapies and other advances that come in its train. The Human Genome Project concerns also countries like Vietnam. Indeed, it concerns every nation on earth and the people of every nation. It is therefore fitting that Australian lawyers, meeting at this conference in Vietnam, should reflect upon the common challenge which is presented to human beings and to their legal systems everywhere by the genetic revolution.

Our meeting in this place requires us to consider not only the responses which the Australian legal system will give to these developments. It also requires us to consider our obligations to ensure that the global response is effective and that the benefits of the Human Genome Project flow to the people of Vietnam and other developing countries as well as to our own people. Otherwise, talk of the genome as an attribute of the common property of humanity will be empty. Such exciting developments deserve to be shared with all people. Lawyers have a responsibility to promote, both in their own countries and internationally, a regime which is equitable, respectful of the dignity of the individual and mindful that the individual is always much more than a collection of his or her genes.

1	Justice of the High Court of Australia. Member of the International Bioethics Committee of UNESCO. Member of the Ethics Committee of the Human Genome Organisation.
2	Modern Law Review, Vol 61 No 5, September 1998.
3	J Black, "Regulation as Facilitation: Negotiating the Genetic Revolution" (1998) 61 Mod L Rev 621.
4	D Beyleveld and R Brownsword, "Human Dignity, Human Rights and Human Genetics" (1998) 61 Mod L Rev 661.
5	S A M McLean, "Interventions in the Human Genome" (1998) 61 Mod L Rev 681.
6	R Deech, "Family Law and Genetics" (1998) 61 Mod L Rev 697.
7	O O'Neill, "Insurance and Genetics: The Current State of Play" (1998) 61 Mod L Rev 716.
8	C Wells, "'I Blame the Parents': Fitting New Genes in Old Criminal Laws" (1998) 61 Mod L Rev 724.
9	C Campbell, "A Commission for the 21st Century" (1998) 61 Mod L Rev 598.
10	For example, the "Biotech century" issue of Time Magazine 11 January 1999 pp 24-55 ("the future of medicine").
11	J D Watson and F H C Crick, "A Structure for Deoxy-Ribose Nucleic Acid" (1953) 171 Nature 737.
12	Human Genome News (1998) 9, 1-2. See http://www.ornl.gov./techResources/humangenome/project/project.html
13	W Gilbert (Harvard University) "Sequencing the Human Genome. Current State" in Fundacion BBV, Human Genome Project, Ethics, Vol 2 (1994).
14	J Kinderlerer and D Longley, "Human Genetics: The New Panacea?" (1998) 61 Mod L Rev 603.
15	UDHGHR, Art 1.
16	Ibid, Art 5(a).
17	Ibid, Art 5(b).
18	Ibid, Art 5(c).
19	Ibid, Art 6.
20	Ibid, Art 7.
21	Ibid, Art 8.
22	Ibid, Art 9.
23	Ibid, Art 10.
24	Ibid, Art 13.
25	Ibid, Art 14.
26	Ibid, Art 15.
27	Ibid, Art 16.
28	Ibid, Arts 17-21.
29	Ibid, Art 24.
30	Ibid, Art 12.
31	Discussed O O'Neill, "Insurance and Genetics: The Current State of Play" (1998) 61 Mod L Rev 716.
32	C Wells, "'I Blame the Parents': Fitting new Genes in Old Criminal Laws" (1998) 61 Mod L Rev 724.
33	"Academy joints debate over DNA patents" (1997) 277 Science : H Varmus, (1997) 277 Science 187. Cf M D Kirby, "Meeting our Friend, the Genome" (1998) 8 Law and the Human Genome Review 60 at 64-66. Contrary views have been expressed. Thus the opposition in the Relaxin case argued that to patent human genes was to patent life, and that that amounted to slavery contrary to the fundamental human right to self-determination. See generally Black, above n 2, at 647.
34	Black, above n 2, 642-643.
35	M Lupton, "Human Cloning - The Law's Response" (1997) 9 Bond Law Rev 123 at 129.