The International Legal Governance of the Human Genome

Chamundeeswari Kuppuswamy

• Publisher: Routledge
• Year: 2009
• ISBN:
  9781134047420
• Edition: 1
• Topic: Law
• Subtopic: Law Theory & Practice
• Index: Law

The human genome is a well known symbol of scientific and technological progress in the twenty-first century. However, concerns about the exacerbation of inequalities between the rich and the poor, the developing and the developed states, the healthy and the unhealthy are causing problems for the progress of scientific research. The international community is moving towards a human rights approach in addressing these concerns.

Such an approach will be piecemeal and ineffective so long as fundamental issues about economic, social and cultural rights, the so-called second generation of human rights, are not addressed. This book argues that, in order to be able to meaningfully apply a human rights framework to the governance of the human genome, the international human rights framework should be based on a unified theory of human rights where the distinction between positive and negative rights is set aside.

The book constructs a common heritage concept with the right to development at its core and explores the content of the right to development through rational human rights theory. It is argued that the notion of property rights in the human genome should be placed within the context of protecting human rights, including the right to development. The concept of common heritage of humanity, contrary to the widely held belief that it is in opposition to patenting of gene sequences, supports human rights-based conceptions of property rights.

This book fills a gap in the literature on international legal governance of the human genome will provide an essential reference point for research into the right to development, development issues in bioethics, the role of international institutions in law making and research governance.

1 The human genome and bioethics

1.1 Introduction

Advances in science and technology have enabled us to alter the human person. It is now possible to replace organs, change one’s appearance drastically, extend one’s life by long periods and even change one’s gender. There is very little we cannot tinker with, in the human body and the natural world. To this long list of achievements, we can now add the discovery of the ‘book of life’.¹ The Human Genome Project (HGP) has revealed, more than any other biology project, the nature of the most important molecules of life—genes. Genes are considered the ‘Holy Grail’ of biology,² and have unlocked the potential for a quantum leap in our understanding of the human body, the functions within it and of life itself.³ The human genome is a well-known symbol of scientific and technological progress. There is also no end to the rhetoric surrounding the human genome. This ‘secular equivalent of the soul’⁴ is the sum total of the genes in the human body and determines a lot of what we are and will become. Since the completion of the HGP in 2003, other projects have come to the forefront. Through the Human Proteome Project, stem-cell research, nanotechnology, robotics and artificial intelligence, we can expect to see the acquisition of more capabilities that are potentially speciesaltering in nature.⁵

In 1952, James Watson, Francis Crick, Rosalind Franklin and Maurice Wilkins discovered the double helical structure of the DNA.⁶ Three of these scientists received the Nobel Prize for their discovery. It revolutionised the understanding of the fundamentals of biology by shifting the focus from the protein molecules, as a basic molecule, to the DNA as a building block of life. In 1953, the first commercially successful general-purpose computer was built by IBM (International Business Machines), as part of the Korean War effort.⁷ Thomas Watson, Jr, in his quest for a ‘defence calculator’ to aid in the policing of Korea by the United Nations (UN), developed the prototype of the home computer. Only 19 of these machines were produced, 13 of which went to the US Department of Defense and the defence industry. Both these developments, along with other scientific breakthroughs, are having a revolutionary impact on biological research and in turn impact health research and health care. As a result, the traditional actors in medicine have also expanded and now include academic researchers and technologists. As more and more research is being funded by public and private bodies whose primary purpose for funding such research is to benefit the taxpayers and share holders, it is expected that such scientific research address issues of direct short-term importance to individuals and groups as well as benefit people in the long term.

1.2 The Human Genome Project (HGP)

The objective of the HGP was to determine the complete sequence of the three billion DNA subunits (technically known as bases—A, T, G, C), identify all human genes, and make them accessible for further biological study.⁸ Scientists embarked on this project because of its fundamental nature. The project aroused immense interest because ‘The particular order of As, Ts, Cs, and Gs is extremely important. The order underlies all of life’s diversity, even dictating whether an organism is human or another species such as yeast, rice, or fruit fly.’⁹

The HGP symbolises the summit of technological excellence in biology at the turn of the century, paving the way for a big role for molecular genetics in the twenty-first century. It has spawned a whole new set of scientific laboratories and has given birth to a new generation of scientists with a fresh outlook on biology. It is a flagship molecular genetics project of the late twentieth century that has been instrumental in thrusting molecular genetics into the international limelight and has made it a matter of political concern at the highest level of interstate relations.

Japan was the first country to start a human genome project, as early as in 1981, when the Science and Technology Agency of Japan (STA), a government department, funded a project on the extraction, analysis, and synthesis of DNA. The project focused on DNA sequencing and involved technology heavyweights such as Seiko, Hitachi and others who produced the earliest DNA sequencing machines, micro-chemical robots, electrophoresis gel systems and other high-tech products, which are essential for analysing DNA. The Japanese project was extended into a second phase in 1984, funded by the STA, under the title ‘Generic Basic Technologies to Support Cancer Research’, making an early link between genomics and health benefits.¹⁰ It later died away as the US played down the competition it faced from Japan in trying to develop high-technology products.

Around the mid-1980s, technologists and mathematicians, particularly in the US, became excited with the idea of designing methods for mapping the units in DNA molecules found in the nucleus of the human cell. They put their efforts into the sequencing of the units present in the DNA and successfully completed sequencing smaller organisms with shorter DNA. The idea that the same could be done with human DNA was taking root in the minds of technologists. The length of the DNA and the complexity involved in mapping the genome caused scepticism among some biologists while others even found it boring. But to computer engineers it posed challenging algorithmic questions.¹¹

Those who opposed the funding of the project did not think it would be worth pursuing the project and accused the supporters of advocating ‘big science’¹² and raised fears about the spread of genetic determinism whereby humans are considered the sum total of their genes. This is also known as reductionism, and the fear is that human activities would be reduced to a mere function of their genes. There were suspicions that the HGP would bring in eugenics by the backdoor.¹³ Geneticists however claimed that it would be very useful to obtain a sequence map of the DNA, which could then be used to identify individual genes. Earlier, the gene for Huntingdon’s disease had been identified using other methods, and was hailed as a major breakthrough in medicine.¹⁴ Eventually geneticists were able to convince the majority about the immense importance of DNA sequencing and its huge potential to overcome human disease and to maintain and enhance human health. It was emphasised that such a project would be of interest to other specialists and in addressing human disease. The promise that this project showed was held to be massive. Even the common cold, referred to as a multifactorial disease (caused by a combination of factors: genetic, environmental and lifestyle factors), could benefit from the knowledge derived from the HGP.¹⁵ Considering the changing nature of scientific research, with the applications of such research to health being a major part of the case put forward for the funding of such research nowadays, it is inevitable that there is scrutiny of how and whether such promises have been kept.

Aided by a favourable set of circumstances and the involvement of charismatic personalities,¹⁶ the international HGP commenced in 1990, mainly in laboratories across the US funded by the Department of Energy and the Department of Health. Other participating countries were Italy, the UK, the USSR, France, Germany, Denmark, the EC, Canada and Japan. The main contribution to the sequencing of the genome came from the UK and the US, which completed about 75 per cent of the map. As the project went along, many innovations in international collaborations were made, thus laying the foundations of scientific standard-setting in the new area of genomics. The Human Genome Organisation (HUGO) was formed in 1988 to bring together the scientists working on the sequencing of the human genome.¹⁷ Informal rules for sharing the rough sequences were made (the ‘Bermuda Rules’) so that labs across the world could access information, almost in real time,¹⁸ which demonstrated that the HGP was a scientific project that was ground breaking in more than one way. Yet another innovation was the parallel research into the ethical and legal implications arising from the mapping of the genes.

Genomics was born into the era of speed, reflecting the nature of the world since the last decades of the twentieth century. The signature statement of the iconic head of the project, Jim Watson, was very much writ into it: ‘Choose a scientific goal and push towards it relentlessly.’¹⁹ Not only was the human genome being sequenced through the public consortium involving international collaborators, but a private firm, Celera Genomics, was independently involved in decoding the human genome.²⁰ The HGP was completed in 2003, two years ahead of schedule, when the whole sequence of the human DNA containing three billion subunits was unveiled to the world by President Clinton and Prime Minister Blair as the ‘book of life’, accompanied by much fanfare and many expectations for the future.²¹

The HGP has heralded a new age in biology and holds the promise to revolutionise medicine. New journals, intended to publish research from projects that use molecular-genetics methods, have sprouted and grown in strength.²² High-speed computing and bioinformatics (use of mathematics and computer technology in biological and medical research) are equal and indispensable partners in genomics research. The technologists have developed new skills and produced new equipment for ever more accurate data collection. Analysts predict that ‘in the coming years, humanity will come to use the computer more and more as a “substitute mind”—or language—to manipulate, redirect, and organise the vast genetic information that makes up the physical substance of living nature.’ Private venture capital funding has changed the culture of scientific research in medicine. The HGP has had direct impact on medical practice, not only in the area of diagnosing hereditary diseases, but more broadly in the diagnosis of other diseases. The impact of the HGP is best described as ‘making inroads into the medical mind’, to borrow the phrase of an American specialist.²³ Personalised medicine is a phrase that is entering into medical practice, referring to the tailoring of treatment according to the genetic make-up of the individual. No doubt, many look at ‘the future of medicine (as) genetic’.

1.3 Scientific research: increasing inequities and inequalities

Concerns about the exacerbation of the inequalities between the rich and the poor, the developing and developed States, and the healthy and the unhealthy are issues that are fundamental to the governance of scientific research. With so much being predicted by way of linking the HGP to health benefits, concerns about the exacerbation of inequalities in health are not unfounded. The fear that genomic science will lead to widening of the gap between the healthy and the unhealthy is not unwarranted. The scepticism of commentators that the progress of genomic science would indeed not help in addressing health issues relevant to majority of the global population is strengthened in the light of analysing the development of internationally applicable rules in the regulation of medical research using humans or materials ...

Table of contents

• Cover Page
• Title Page
• Copyright Page
• Foreword
• Preface
• Acknowledgements
• Table of cases
• 1 The human genome and bioethics
• 2 International organisations and the human genome
• 3 The common heritage of mankind (CHM) in international law
• 4 The common heritage of mankind (CHM) and the right to development (RTD)
• 5 Human rights, common heritage and development
• 6 The common heritage of mankind (CHM) and intellectual property rights (IPR)
• 7 Conclusion
• Appendix
• Bibliography