The Human Genome as Common Heritage of Mankind - Jean Buttigieg - ebook

The Human Genome as Common Heritage of Mankind ebook

Jean Buttigieg

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Opis

In this timely study, Jean Buttigieg demonstrates the necessity to make it a legal principle of international law that the human genome is a common heritage of mankind. In 1997, the UNESCO General Conference declared the human genome a common heritage of humankind. This declaration was followed by the Joint Statement of March 14, 2000, by US President Bill Clinton and British Prime Minister Tony Blair, in which they stated that the “fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere.” This announcement to allow “unencumbered access” to this fundamental data on the human genome, for the benefit of all humanity, appeared to endorse the UNESCO Declaration of 1997 on the human genome. But as it turns out, these statements were only political slogans since there is a complete lack of any genuine attempts to make the human genome a legal principle of international law so far. This study's foremost goal is to re-introduce the philosophical and political implications of the concept of common heritage of mankind into public discourse, as intended by Arvid Pardo when he addressed the UN General Assembly on November 1, 1967, and apply them to the human genome. As Buttigieg demonstrates, the biggest challenge here comes from the patent system in its present form, which encourages the commercialization of the human genome by explicitly denying scientists “unencumbered access” to the fundamental raw data. By putting individual rights before community rights, the patent system effectively hinders discoveries that prompt new and better medical treatments. Buttigieg also discusses issues of biotechnology. While the biotechnology debate is very often centred on which new applications of biotechnology should or should not be permitted, it so far lacks a critical philosophical analysis of biotechnology itself. The true essence of the human genome, Buttigieg argues, is to be found in metaphysics and not biology. This study fills a gap in the literature on the human genome and the common heritage of mankind by addressing the metaphysical nature of the human genome and discussing the philosophical concerns surrounding the field of biotechnology.

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ibidem Press, Stuttgart

 

 

Table of Contents

Dedication

Abstract

Acknowledgements

Introduction Arvid Pardo and the Human Genome

0.1 The Race to Grab the Bounties of the Seabed and Ocean Floor

0.2 The Race to Grab the Bounties of our DNA

0.3 The Technology Question

Chapter One The Human Genome—Common or Patentable Subject Matter?

1.1 The Human Genome as Common Heritage

1.2 The Human Genome as Patentable Subject Matter

1.3 The Anti-Commons of Biomedical Research

1.4 Patenting Life

1.5 Biotechnological Patents versus Public Morality

1.6 The Stem-Cell Market

1.7 Patents and the Pursuit of Scientific Progress

1.8 Who Owns You?

Chapter Two Human Genome as Common Heritage

2.1 Philosophical Concept or Political Slogan?

2.2 Beneath the Surface of the Common Heritage of Mankind

2.3 The Birthright of the Common Heritage of Mankind

2.4 The Common Heritage of Mankind as a Model of Political Stewardship

2.5 The Common Heritage of Mankind as a Challenge to Legal Positivism

2.6 Preventing Another Mare Liberum

2.7 Making the Common Heritage of Mankind a Legal Principle of International Law

2.8 The International Management of the Human Genome as a Common Heritage of Mankind

2.9 Extrapolating with the Common Heritage of Mankind

2.10 Further Reaches of the Genome

2.11 Launching the Global Governance of the Human Genome

Chapter Three The Human Genome as Heritage of Humanity in a Symbolic Sense

3.1 Formatting the Genome

3.2 Genes in a Test Tube?

3.3 Darwin Revisited!

3.4 The Genie in the Genome

3.5 The Transcendental Nature of the Human Genome

3.6 A Thought Experiment

3.7 Of Genomes and Souls

3.8 The Human Difference

Chapter Four Questioning the Nexus Between Biotechnology and the Human Genome

4.1 In the Shadow of Technology

4.2 Unconcealing the Concealed in Technology

4.3 Transforming Technology

4.4 Technological Stewardship

4.5 The Genome and the Enigma of Health

4.6 The Art of Healing as an Epiphany for Biotechnology

4.7 The Permanent Limitations of Biology

4.8 Ethics for Biotechnology

4.9 The Tragedy of Biotechnology

4.10 Re-Thinking Biotechnology with the Human Genome as Common Heritage of Mankind

4.11 The Embryo Question

Conclusions

Bibliography

Studies in Medical Philosophy

Copyright

Dedication

I would like to dedicate this thesis to my wife Mariella and my children Emmanuel and Maria Lara in recognition and appreciation of their unwavering support during my studies.

 

Abstract

There are three main goals that this research study will seek to achieve. The first is to make the human genome, as a common heritage of mankind, a legal principle of international law. Already in 1997, the UNESCO General Conference declared the human genome the common heritage of humanity, in a symbolic sense, in its Declaration on the Human Genome and Human Rights. This declaration was followed by the Joint Statement of 14 March 2000, by President Bill Clinton and British Prime Minister Tony Blair, in which they stated that the ‘fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere’. The two leaders’ announcement to allow ‘unencumbered access’ to this fundamental data on the human genome, for the benefit of all humanity, appeared to endorse the UNESCO Declaration of 1997 on the human genome.

But it is our contention that these references to the human genome as common heritage of mankind were only political slogans rather than genuine attempts to makethe human genome, as a common heritage of mankind, a legal principle of international law. Our goal is to re-introduce, into public discourse, the philosophical and political implications of the concept of common heritage of mankind, as intended by Arvid Pardo when he addressed the UN General Assembly on November 1, 1967, and apply them to the human genome.

The second goal of this research study is to demonstrate that the biggest challenge to making the human genome the common heritage of mankind comes from the patent system as it is presently operated, that encourages the commercialization of the human genome by denying scientists ‘unencumbered access’ to the fundamental raw data on the human genome. By putting individual rights before community rights, the patent system is not conducive to promoting discoveries that improve health by providing new and better medical treatments.

The third goal concerns the issue of biotechnology. While the biotechnology debate is very often centred on what new applications of biotechnology should or should not be permitted, there is missing a critical philosophical analysis of biotechnology itself that can no longer be ignored if we do not want the human genome to fall victim to modern science’s project of complete mastery of nature, including human nature. This philosophical analysis should lead to a re-introduction, into public discourse, of the notion that the true essence of the human genome is to be found in metaphysics and not biology. This will entail resisting the trend of modern science to consider as irrelevant any metaphysical considerations on the human genome.

These are the concerns that will be made subject to philosophical scrutiny throughout this research study. In the first chapter, we will be discussing the different ways how the patent system is generating an ‘anti-commons’ in biomedical research. In the second chapter, we will carry the concept of common heritage of mankind from the deep seabed to the human genome. The metaphysical nature of the human genome will be the subject of the third chapter while in the last chapter we will focus our attention on the contributions of Martin Heidegger and other philosophers on issues concerning technology and biotechnology, in particular. We will also discuss the ways how these philosophical concerns relate to the human genome. The last section will consider a number of political initiatives that can be taken with the purpose of promoting, on the international level, the legal recognition of the human genome as a common heritage of mankind.

Our research study is meant to fill a gap in the literature on the human genome and the common heritage of mankind that tends to ignore the ‘anti-commons’ effect of the patent system on biomedical research and gives very little importance to the metaphysical nature of the human genome and to the philosophical concerns surrounding the field of biotechnology.

 

Acknowledgements

I am deeply indebted to Rev. Professor Emmanuel Agius without whose supervision and intellectual support I would not have been able to conduct this research study.

 

IntroductionArvid Pardo and the Human Genome

0.1 The Race to Grab the Bounties of the Seabed and Ocean Floor

The nexus between Arvid Pardo and the human genome is the concept of common heritage of mankind. This concept is synonymous with Pardo who, as Permanent Representative of Malta to the United Nations, presented to the world a revolutionary new idea of international management of the natural resources of our planet Earth that was to challenge the very foundations of economic thinking and international law.1 He called for the establishment of some form of international management of the seabed and ocean floor that were beyond national jurisdiction.2 Pardo was concerned that the world’s seabeds and much of the ocean floor were subject to exploitation by those countries that had the technology to do so.3 At the same time, those countries that did not have this technology would end up with nothing. Pardo was personally convinced that the natural resources4 which were to be found on the seabed and ocean floor were so plentiful that their exploitation by the developing countries could help bridge the gap between the North and the South.5 This was a golden opportunity for mankind to use the natural resources of the planet in a way that everyone would benefit from them. Pardo’s proposal to the United Nations was that all humanity will take it upon itself to create the conditions necessary for the exploitation of the seabed and ocean floor for the benefit of all mankind and set a precedent that would make it contingent on mankind to make the preservation of the conditions necessary for the continued existence of humanity, the primary objective of responsibility.6

The problem that Pardo faced was that there was no well-defined legal framework that could prevent this unfair exploitation of natural resources because the high seas were still subject to the laissez faire laissez passer attitude of Grotius’ Mare Liberum.7 He was sure that this ambivalent situation would lead to conflicting claims of appropriation by different countries and inevitably there would be serious tension between the developed countries and the developing ones. He was adamant that the great injustices of the past would not be repeated in the present. In the first lines of his speech, Pardo explained to the General Assembly that:

The dark oceans were the womb of life; from the protecting oceans life emerged. We still bear in our bodies—in our blood, in the salty bitterness of our tears—the marks of this remote past. Retracting the past, man, the present dominator of the emerged earth, is now returning to the ocean depths. His penetration of the deep could mark the beginning of the end for man and, indeed for life as we know it on this earth. It could also be a unique opportunity to lay solid foundations for a peaceful and increasingly prosperous future for all peoples.8

Pardo envisaged a future where the world’s seabeds and the ocean floor would be exploited under international auspices for the benefit of the whole of mankind rather than by a few countries for the benefit of the few.9 For these reasons, Pardo employed the phrase common heritage of mankind which implied that no state could appropriate these natural resources because they belonged to all of humanity, those living and also those who still had to be born.10

One of the objects of our study will be to show that with the launch of the Human Genome Project (HGP) that marked the beginning of a new era of resource exploitation, that of the human genome, another appeal must be made to the General Assembly of the United Nations to assume the responsible stewardship of the human genome through the establishment of some form of international management as envisaged by Arvid Pardo so as to prevent the unilateral exploitation of the human genome by those nations that have the technical capability to do so. It is also our contention that the situation is more urgent today when the patent system provides the public and private entities that exploit the human genome with proprietary rights that, as we shall demonstrate, have given rise to the tragedy of the anti-commons.

Arvid Pardo, in his speech to the General Assembly, specifically avoided referring to these natural resources as belonging to the whole of mankind. What Pardo had in mind and it was in this formulation that he was prophetic, was a new concept of the use of property that was not in any way related to appropriation. His was a new vision of resource management where these common resources would not be subject to appropriation of any kind, public or private, national or corporate. Sovereignty would be absent as would all legal attributes and ramifications.11 The notion that the deep sea and ocean resources were the legacy of humanity had already been expressed by President Lyndon Johnson in 1966 but Pardo’s idea of common heritage of mankindwas diametrically opposed to that of President Johnson. In 1966, at the inauguration of the Oceanographer, Lyndon had said, to the surprise of many:

Under the circumstances, must we even allow the prospects of rich harvest and mineral wealth to create a new form of colonial competition among the maritime nations. We must be careful to avoid a race to grab and hold the lands under the high seas. We must ensure that the deep seas and the ocean bottom are, and remain, the legacy of all human beings.12

President Johnson was very much aware that the race to grab the bounties of the seabed and ocean floor had already started when in 1945 US President Harry Truman declared that the seabed of the continental shelf beneath the high seas but contiguous to the coasts of the US belonged to the US.13 This action on the part of the Americans prompted other countries to do the same as they too wanted their share of the natural resources to be found on the seabed and ocean floor. Proof for the existence of these resources was given in 1873 when the Challenger expedition discovered potato-sized manganese nodules scattered across large areas of the seabed at depths of around 3,500 metres.14 Then in 1958 the Convention of Geneva on the Law of the Sea declared that the coastal states had the sovereign right to exploit and explore the resources of the continental shelf as long as these resources were to be found in depths of 200 metres or less and that they were indeed exploitable.

Pardo was not pleased with this chain of events because he feared that the Geneva Convention could allow a coastal state to divide the seabed and its resources with another coastal state on the opposite side of the sea. In this way, the countries that had the technological means to exploit these resources, and there weren’t many countries that had this technology, would have exclusive rights to these undersea resources.15 The majority of countries, especially the developing ones, lacked this technological capability and they feared that the free exploitation sanctioned by the Geneva Convention would lead to a carve-up of the seabed and all its resources which, according to oceanographers, potentially comprised the largest mineral deposit on this planet.16 Even though these countries lacked the technology to exploit these resources, they wanted to reserve the right to do so in the future.17

Paradoxically, it was an attempt to keep the high seas free for navigation and fair trading that made possible this ambivalent situation where stronger nations could monopolize the high seas for their personal gain and exclude other nations from their share of the prize. The occasion was the seizure, on 25 February 1603, of a richly laden Portuguese galleon by a Dutch Admiral employed by the Dutch East India Company (VOC) in the straits of Malacca as a form of protest against the decision of Spain and Portugal to exclude all foreigners from navigating the Pacific and Indian Oceans. The VOC had only been formed a year before in 1602 and the exclusion policy of Spain and Portugal was preventing it from doing trade with the East.18 Eager to convince its potential allies of its justification for abducting the Portuguese galleon and the reasons why it took such a drastic form of action, the VOC appointed Hugo Grotius to write a defence in which he would do just this. Grotius was immediately aware that his brief would have very serious implications for the freedom of navigation and more so, for the freedom of trade.19 As a legal basis for his defence, Grotius turned to natural law as opposed to the man-made laws of a specific nation or jurisdiction. Choosing the Tribunal of Conscience and the Tribunal ofPublic Opinion as pillars for his defence, he made it clear that the laws of nature written in the minds and hearts of every individual are immutable and universally given.20 To set the tone for his brief with the serious political and economic implications it carried, Grotius began his defence by stating:

To this tribunal we bring a new case. It is in very truth no petty case such as private citizens are wont to bring against their neighbours about dripping eaves or party walls; nor is it a case such as nations bring against one another about boundary lines or the possession of a river or an island. No! It is a case which concerns practically the entire expanse of the high sea, the right of navigation, the freedom of trade! Between us and the Spaniards the following points are in dispute: Can the vast, boundless sea be the appendage of one kingdom alone and it not the greatest? Can any one nation have the right to prevent other nations which so desire, from selling to one another, from bartering with one another, actually from communicating with one another? Can any nation give away what it never owned, or discover what already belonged to some one else? 21

Grotius based his defence for the freedom of the seas and the right to free trade on the distinction, in Roman Law, between two forms of legal ownership, res nullius 22 and res communis.23 The question for Grotius was whether the sea was res nullius or res communis? Res nullius referred to those territories and resources that as such belonged to no one by default because no one would have as yet appropriated them or laid claim to them. Legally, however, these territories and resources could be appropriated or exploited by a recognized sovereign if sovereignty or possession could be demonstrated and performed through discovery and effective occupation.24 Once this process was fulfilled, territories or resources formerly regarded as res nullius could become transformed legally into territory subject to the exclusive ownership or jurisdiction of the sovereign who would have started the process in the first place.25 With res communis the situation is totally different because in this case the territories or resources held in common possession could never become appropriated or laid claim to because they had to remain available for use by everyone. Hence these territories were not and could never be subject to sovereign claims of appropriation.26

By drawing on this distinction between res nullius and res communis and how land or resources in the former type of ownership can be subject to appropriation but not in the latter case, Grotius comes to the conclusion that the sea, which as yet had never been the subject of appropriation, was, by default, res communis and therefore the claim of Spain and Portugal for exclusive right to the Pacific and Indian Oceans was illegal. His views echoed the position of the second-century Roman Jurist Marcianus, who wrote that the sea, its fish and even coastal waters were communis omnium naturali jure and so ‘common or open to all men by the operation of natural law’.27

However, Grotius did not exclude the possibility that part of the res communis can, in actual fact, become subject to private appropriation, as long as the occupation or appropriation is conditional to two fundamental imperatives, namely that the said occupation or appropriation does not impair its common use and that if necessity dictates, what is private will become common again. He gives as examples what happens on board a ship when, if food becomes scarce, it is gathered in common, and how the Romans, despite allowing their subjects to occupy the shoreline, denied them the right to prevent anyone from accessing the shoreline and doing what was traditionally considered permissible.28

In conclusion, Grotius makes it clear that Spain and Portugal were wrong in their claim to exclude foreigners from navigating the Pacific and Indian Oceans because the sea was res communis omnium,29 meaning, for the common use of all and so it had to remain. The problem was that as long as the legal framework related to the high seas was primarily concerned with ensuring freedom of navigation and freedom of trade, there was very little concern for disputes between countries related to the use of the high seas. In fact, Grotius’ Mare Liberum encouraged a laissez faire, laissezpasser attitude that did not pose any serious international problems for over three centuries after its publication. It was only when the Challenger30expedition found the manganese nodules on 1873 and US President Harry Truman declared, in 1945, that the US had a claim to the natural resources of the seabed of the continental shelf contiguous to the coasts of the US, that trouble started.31 Mexico, Panama, Argentina, Peru and many other nations made similar claims for extension of sovereignty over the continental shelf and its resources. The first conflicts involved coastal states and distant-water fishermen over the coastal fish stocks. In 1954, a fishing fleet belonging to the magnate Aristotle Onassis was captured after the Peruvian authorities opened fire on the fleet. The fleet which included a factory ship was flying the Panamanian flag and the incident took place 300 miles off the coast of Peru. A fine of over $3 million had to be paid to have the boats returned.32

0.2 The Race to Grab the Bounties of our DNA

The race to grab the bounties of our DNA did not actually start with the launching of the HGP, as many have been led to believe, but rather with the discovery, in 1953, of the molecular structure of DNA by James Watson and Francis Crick.33 Their discovery set the stage for a new science of the human genome that, with the HGP, has proved to be the gateway to a new biotechnological era. Already Watson and Crick had predicted that their discovery would, in the future, make it possible for scientists to understand biology in terms of physical and chemical processes34 and even life, for that matter, would be explicable in terms of its molecular structure.35

The launching of the HGP by the US National Institutes of Health (NIH) in 1990 promised oceans of data as the people behind the HGP set themselves the goal of determining the sequence of the 3 billion chemical base pairs that made up human DNA so as to store the information in a database.36 The work was completed by April 2003 and the genetic nucleotides were published on the internet along with an estimated 25,000 genes that coded for the proteins that formed our cells and tissues.37

But it immediately became clear that these oceans of data were susceptible to exploitation38 because as soon as the multibillion dollar effort to decipher the human genetic code got underway, the Great Gene Grab39 began! By the time the first draft of the human genome was completed, the map of the human genome was cluttered with flags marking genes that had been patented by biotech companies. If the genome was the moon, then Neil Armstrong would have discovered that large areas of the moon had already been divided among biotech companies before he had the chance to set his foot on it and proclaim, ‘one giant leap for mankind’.40 The irony is that the first hijacker of the human genome was none other than the NIH itself which was among the first to patent the DNA sequence data after two of its scientists discovered a technique that made it possible for them to find genes at an unprecedented speed. Although the NIH eventually withdrew its patent claims, its action triggered a race to the patent office by several countries who also filed patent applications for their own sequences. The UK was the first country to respond, followed by Japan, Germany and Switzerland, all participants to the HGP.41

A survey carried out by Kyle Jensen and Fiona Murray focussing on the US has shown that nearly 20% of human genes are explicitly claimed as US Intellectual Property (IP).42 This figure represents 4382 of the 23,688 of genes in the gene database of the National Centre for Biotechnology Information. These genes that are claimed in 4270 patents within 3050 patent families are owned by 1156 different assignees of which roughly 63% are private firms. Of these, among the top ten we find nine US-based firms, including the University of California, Isis Pharmaceutical, the former Smithkline Beecham and Human Genome Sciences.43

While most of the genome is still unpatented, there are some genes that are heavily patented such as BMP7, an osteogenic factor and CDKN2A, a tumour suppressor gene. The gene sequences in both cases are claimed in at least twenty patents, mostly directed towards diagnostic applications. The same holds for other important disease genes such as BRCA1( breast cancer), PIK3R5 (diabetes) and LEPR (obesity).44

Many institutions, scientists and individuals are concerned that gene patenting halts scientific progress because it discourages scientists from continuing to do research on genes once they have become patented.45 Take Hereditary Hemochromatosis, for example. It is an autosomal recessive disease affecting mainly people of European descent. Up to 85% of cases of Hereditary Hemochromatosis are caused by two mutations in the Hemochromatosis gene. While there were several US laboratories performing testing for mutations, as many as 30% stopped developing a genetic test or stopped testing for mutations altogether after the gene was patented. As a result, the validation of genetic testing has not proceeded as quickly as it would have if the mutations had not been patented.46

The promise and perils of gene patenting can be illustrated with the human epidermal growth factor receptor-2 (HER2) and Tratuzumab (Herceptin). Tratuzumab is an effective antibody against a known breast cancer oncogene which ‘instructs’ the HER2 gene to either stop the cancer from continuing to spread or to signal to the immune system to destroy the cancer cell. Tratuzumab therapy has been shown to increase survival among women with metastatic as well as localized breast cancer. The downside is that Genetech Inc. which holds the patent for Tratuzumab, also holds multiple patents related to the HER2 gene and HER2 ligands. This means that anyone who wants to develop a breast cancer treatment based on the HER2 gene must obtain permission from Genetech or risk being sued for patent infringement. Hence it is not at all surprising that the drug is so expensive with the annual cost of Tratuzumab therapy in Canada being as high as $50,000.47

Professor Emmanuel Agius, Member of the European Group on Ethics (EGE) and others have also expressed their concern as to the patentability and commercialization of genetically engineered living products of biotechnology. Although they have no issue with granting the inventor a just reward for his work, they have expressed serious concerns about the ownership and dominion over living nature, as regulated by the patent system, and are concerned as to how the long-range effects of granting exclusive rights over new life forms can affect the future of the human species.48 Professor Agius has spoken of the urgent need for a World Patent Convention on Biotechnological Inventions in view of the rapid advances in biotechnology that are being made and in view of the fact that many industrialized countries are increasing their budgets to support the budding biotechnology industry.49

The situation faced by Arvid Pardo in 1967 is very similar to the situation that we now face today with the human genome. The human genome consists of genes and genetic information. It is information on the life of humanity and accordingly, the human genome should be considered a ‘common inheritance’.50 In addition, as the genes themselves are the place where this genetic information is stored, the genes and genetic information they provide together constitute the common heritage of humanity and as such are res communis. Accordingly, the human genome, as rescommunis, cannot be owned by anyone, must be available for use by everyone and can never be appropriated by anyone.51 It stands to reason that the patent system, based on granting exclusionary rights in the form of intellectual property rights to inventors, is incompatible with declaring the human genome the common heritage of mankind which is a concept based on community interests rather than individual interests.52 This will mean striking a balance between rewarding and protecting an inventor for his or her research work and ensuring that inventor’s research is made freely and rapidly available to other researchers for the benefit of all mankind.

Arvid Pardo’s suggestion to the United Nations General Assembly was to establish some form of international management of the seabed and ocean floor so as to ensure that these resources are explored, prospected and exploited for the benefit of all mankind and so no one is left out. He was faced with the probable monopolization of the resources of the deep seabed by highly developed countries that had the technology to exploit these biological and mineral resources.53

The patenting system as presently practised is mainly centred in the northern hemisphere by developed countries.54 As it is, the system is contributing in no small measure in widening the gap between the developed and developing countries when multinational firms, owned by the developed countries, are protecting their own interests by acquiring monopoly control through the patent system, over genetic resources and biotechnology.55 As it is the chances of the Third World to gain access to scientific information and rights to license this technology are being seriously threatened.56

A similar situation exists with the human genome because most of the research on the genome is in actual fact monopolized by the highly developed countries. Considering that the objective of research on the human genome is focussed on the improvement of human life and that such research may influence and even decide, the future of each person and so of humanity as a whole, it becomes imperative that the human genome does not remain the object of appropriation by these countries in order to ensure an equitable sharing of the benefits from this common resource among all mankind. Hence, as in the case of the seabed and ocean floor, the current situation calls for some form of international management of the human genome to ensure that the inspiring principles of the concept of common heritage of mankind will not only guarantee the well-being of both the present and future generations of mankind but also thwart any potential threats to mankind by the granting of ownership rights on the human genome.

0.3 The Technology Question

So far our attention on the human genome has focused mainly on making the human genome the common heritage of mankind. This is only the tip of the iceberg because, from a philosophical perspective, our concern must also focus on the subtle way that biotechnology has conditioned the way we look upon the human genome. Biotechnology is a reality that we very easily take for granted because we very often assume that it can only make life better for us as long as we use it within the confines of our legal system. It is our contention that such an approach to biotechnology will only obscure the dangers that are inherent in the same biotechnology that modern science tends to propose as the key to the solution of all our problems of ill health. It was Martin Heidegger who first subjected technology to philosophical scrutiny with his essay, The Question Concerning Technology 57 in which he focused on the way the relation of man to technology has changed as a result of the different manner in which the older forms of technology and modern technology reveal the world to man. At the same time that Heidegger wrote the essay, biotechnology was still a limited application of technology that did not raise any particular ethical concern. The situation is very different today when biotechnology has not only become one of the most powerful technologies in the hands of modern science but it is also considered the technology that poses the most serious threat to mankind!58 For these reasons, the concerns expressed by Heidegger in relation to modern technology are particularly applicable to biotechnology that is the main focus of our study. As we shall make clear in the course of our research, it is only after we have unmasked the dangers inherent in biotechnology that can adversely affect the way we value the human genome will we be able to put the human genome at the centre of biotechnology in the interests of mankind. It is our firm belief that the concept of common heritage of mankind is the most suitable form of resource management of the human genome for and on behalf of all mankind as opposed to the patent system as presently operated that encourages the commercialization of the human genome in the interests of the few.

In his essay, Heidegger begins by describing older forms of technology as a form of poesis, which in Greek means to make, to produce and tomanufacture and from which the English word for poetry is derived. Viewed in this light, the River Rhine is ‘revealed’59 to man primarily as a source of philosophical inspiration and cultural pride. The same cannot be said of modern technology that stands in a completely different relation to the world which can be best described as one of ‘challenging forth’ that demands from man an instrumental stance vis-à-vis the world.60 Using words borrowed from Martin Buber, with modern technology, the ‘I and Thou’61 relation between man and the world is reduced to an ‘I and It’ where the ‘It’ is man who unknowingly allows himself to be placed in the ‘iron cage’ of technology!62 In this light, the River Rhine is seen primarily as an energy resource and by the building of a dam, becomes transformed into a hydroelectric power plant. According to Heidegger, this revealing by modern technology of the River Rhine as an ‘energy resource’, induces an instrumental stance to nature that puts to the River Rhine, the unreasonable demand to supply energy which can be extracted and stored.63

The problem for Heidegger is that moderntechnology does not stop at revealing the world to man as an energy resource but it also reveals man to himself as another energy resource that is challenged forth to be transformed into energy reserve.So, the forester who walks the forest just like his grandfather did in the past, is no longer seen, in an existentialist perspective, as the person who can have a privileged ‘I and Thou’ relation64 with nature but, on the contrary, the demands of modern technology make the forester one cog in the machine that puts the paper industry at the mercy of the printing industry that ultimately transforms the public consumer into a source of profit.65 Seen in this light, the forester is a mere ‘It’ who must succumb to the demands of modern technology.

For Heidegger, the real threat to man from technology does not come from atomic weaponry or other destructive devices which can destroy us physically. Rather, the threat comes from living under the sway of the technological view of reality that may well destroy the spiritual essence of man.66 Hence, for Heidegger, the essence of technology is by no means anything technological and therefore it is not to be found in various activities associated with modern technology. Rather, it is to be found in the human impulse to put the world into boxes, to enclose all of our experiences of the world within categories of understanding that we can control.67 This impulse to control the world which Heidegger calls ‘enframing’ is the essence of technology and as such it precedes and determines the development of modern science.68

However, Heidegger is not content with merely identifying ‘enframing’ as the essence of modern technology—he proceeds to demonstrate how human beings should stand in relation to technology. For Heidegger, the question about how we are to relate to technology always comes too late since we are already caught up in an ‘enframing’ view of nature as much as we are caught up in the concrete realities of technological development. Nonetheless, he believes that we can gain some perspective on our own orientation to the world and in so doing, achieve a perspective on technology. What is crucial to Heidegger is that we establish a free relationship with both the world and modern technology because it is the same impulse that has attracted man towards understanding the world and the process of revealing that rules in modern technology. There is a continuum between the way the River Rhine is today revealed as an energy resource and the manner in which a silver chalice was, in the past, revealed by the silversmith’s handiwork which brought it out of concealment. Prior to the silversmith’s work on the raw material from which the chalice was made, the chalice was only potentially a chalice and this potentiality became actualized in the hands of the silversmith and so the chalice is revealed.69

For Heidegger, that which poses the threat also contains the possibility of rescue within itself. He believes that we can achieve a balanced life and keep technology in its place.70 This means entering into a new relation with technology which will involve being able to walk away from it in order to free ourselves from it so as to become aware of the transcendent dimension within which we exist.71 Inspired by the work of Heidegger, Charles Taylor argues, in his Ethics of Authenticity, that although we may appear to live in an ‘iron cage’,72 still we remain free to remake the conditions of our existence when we choose to dominate the things that tend to dominate us. Accordingly, instead of seeing technology in the context of an ever-increasing control and domination, he argues in favour of working towards an alternative ‘enframing’ of technology understood in the moral frame of an ethics of practical benevolence.73

In a slightly more negative vein, Hans Jonas acknowledges that human ingenuity has engendered a giant mechanism and no one can tell what its ultimate repercussions may be:

Outstanding in prestige and starving in resources whatever belongs to the fullness of man, the expansion of his power is accompanied by contraction of his self-conception and being.74

Still, like Heidegger, he believes that the ‘remembrance of Being’ should become a spur to the ethical betterment of humanity in the here and now.75 Although we cannot remove the technological threat we have brought about, just as we cannot do away with technology itself as it is indispensable for our survival, the prevention of its disastrous consequences must represent a constant task for moral theory.76 Hans Jonas was one of the first philosophers to speak about the inadequacy of traditional ethical theories in relation to the extension of human power through the advancement of technology and the need to take action to counteract this power.77 For Jonas, with the advent of modern technology, man’s power to change the world for the better or for the worse increased to such an extent that the adequacy of pre-technology ethical thinking began to be called into question. Prior to the advent of modern technology, the effective range of human action was relatively localized, and as such, nature was immune from any serious harm resulting from man’s actions.78 But with the power that homo faber 79 was able to harness from nature, the consequences of man’s actions became entirely unpredictable.

Today, while man is very much aware of the power he has to change himself through biotechnological intervention and the biosphere through technological intervention, he is very little aware of how he himself is being shaped in ways that he cannot comprehend by the same technology that he thinks he has under his complete control. The Imperative of Responsibility is Jonas’ answer to the ‘heuristics of fear’ 80 that must guard mankind against the unpredictable consequences of ever more powerful technologies that today include nuclear technology, robotics and biotechnology among others:

[Man ought] not to ruin (as he well can do) what nature has achieved in him by the way of his using it. Beyond this commitment to himself, he becomes the custodian of every other end in itself that ever falls under the rule of his power.81

Arvid Pardo and Hans Jonas have taken it upon themselves to carry out this moral task to warn the world community about the disastrous effects that technology can have on the future of mankind. Both Pardo and Jonas had their own different stance towards technology unlike Heidegger who preferred to escape away from technology by choosing to go and live in the Black Forest for the later period of his life.82 At one end of the spectrum, Jonas adopted an extremely cautionary stand in relation to technology for fear of letting instrumental reason, the product of the technological age, to subjugate mankind to a process of dehumanization that will ultimately deprive us of our humanness. At the other end of the spectrum, Pardo had no qualms about the positive contribution technology could make to human society. His sole concern was that technological capability would not be used as a tool in the hands of the developed countries to deprive the less-developed and technologically advanced countries from benefiting from the resources of the deep seabed as they lacked the technology to do so. It is for this reason that he chose to propose to make the deep seabed the common heritage of mankind.

Many today are showing the same concerns expressed by Pardo and Jonas when they see the human genome becoming more patentable subject matter and less common heritage of mankind with every day that passes. On the one hand, the patenting system, based on free-market thinking, does not ensure an equitable sharing in the benefits that are accrued from the exploitation of the data acquired from studies on the human genome. On the other hand, the threat of dehumanization posed by technology to the human species has assumed a new dimension with a biotechnology that can be used to make alterations to the human genome!83

The public was understandably overwhelmingly enthusiastic about the benefits that would result from the data collected by the HGP researchers when the full sequence of the last chromosome was published in the magazine Nature84 in May 2006. Everyone was anxious to see how this vast storehouse of genomic information could be rapidly developed into new products to diagnose and treat human disease. Many recalled the words of US President Bill Clinton who had announced on 26 June 2000, after the completion of a ‘working draft’ DNA sequence of the human genome, that the data offered mankind the possibility to learn the language in which God created man and that the knowledge acquired from this data would give mankind an immense power to heal.85 Three months earlier, on 14 March 2000, Bill Clinton and Tony Blair had stated that the ‘raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere’.86

But scientists who are trying to understand human biology and disease at the level of individual genes with the aim of providing better diagnostics, treatments and cures have in fact been denied ‘unencumbered access’87 to this fundamental data because of the exclusive proprietary rights that the patent system grants to patentees. The truth of the matter is that the patent system is proving to be an obstacle to the promotion of health and the prevention of disease.

Scientists will not be able to proceed effectively with their research if they are not given the freedom to choose their own research objectives and method. For Michael Polanyi, the most effective way of organizing scientific research is by having independent initiatives undertaken by competing scientists. In this way, as long as a scientist keeps an eye on the work of other scientists, he will take their efforts into account when formulating his own research questions. Polanyi has labelled this system as a ‘systemof self-coordination by way of mutual adjustments of independent initiatives’.88 This coordination should not be centralized but rather it should be guided by an ‘invisible hand’ similar to the ‘invisible hand’ of a free market economy that encourages producers and consumers to make supply meet demand and thus achieve maximum welfare.89 Likewise, the ‘invisible hand’ of research will guide scientists to achieve maximum progress of science.90 This method of doing science can be guaranteed by making the human genome the common heritage of mankind which is a concept based on community interests rather than individual interests.91

In the following chapters, we will demonstrate how a ‘common heritage’ model of management of the human genome, inspired by Arvid Pardo’s prophetic vision of resource management, will ensure an equitable sharing of the benefits that can be derived from research on the human genome. Despite the fact that a number of contemporary authors have shown a renewed interest in the concept of common heritage of mankind, they have failed to analyse the concept from a philosophical perspective. This explains the difficulties that international lawyers and economists encounter when they try to make sense of the conundrum of meanings that have been attributed to the common heritage of mankind. In our study we will consider the common heritage of mankind as first and foremost a philosophical concept that has its roots in natural law and the model of Good Stewardship. The advantage of this approach is that we will be able to demonstrate the original meaning that Arvid Pardo intended to give the concept of common heritage of mankind and then apply this to the human genome.

We will also propose the creation of a model of governance of the human genome on the same lines as the International Seabed Authority that will be referred to as the International Human Genome Authority. This Authority will be able to provide an ethical foundation for all biotechnological inventions and discoveries that are derived from the human genome. In order to achieve this, the establishment of the Authority must be accompanied by (i) a re-thinking of the patent system and (ii) a re-evaluation of the biotechnology debate that tends to obscure the relevance of metaphysical considerations on the human genome. In the next section of our study, we will be focussing our attention on issues related to the patentability of the human genome and ‘anti-commons’ effect that the patenting system has on biomedical research. We will also discuss the reasons why the human genome was declared to be the ‘common heritage of humanity, in a symbolic sense’ and the reasons why we consider the patent system that grants exclusive property rights to inventors, to be incompatible with the concept of common heritage of mankind.

 

1 Arvid Pardo, Address by Arvid Pardo to the 22nd Session of the General Assembly of the United Nations (1967), Official Records of the General Assembly, Twenty-Second Session, Agenda Item 92, Document A/6695.

2 Address by Arvid Pardo to the 22nd Session of the General Assembly of the United Nations (1967), Official Records of the General Assembly, Twenty-Second Session, Agenda Item 92, Document A/6695.

3 Jack Barkenbus, Deep Seabed Resources: Politics and Technology (New York: Free Press, 1979), p. 33.

4 Manganese nodules have been found in all oceans and estimates of their aggregate weight runs into trillions of tons.

5 Arvid Pardo, The Common Heritage of Mankind: Selected Papers on Oceans and World Order 1967–1974 (Malta: Malta University Press 1975), p. 2.

6 Pardo’s proposal is reflected in the Declaration of the Principles Governing the Seabed and the Ocean Floor, and the Subsoil Thereof, beyond the Limits of National Jurisdiction, adopted by the General Assembly of the United Nations at its 25th Session on 17 December 1970.

7 Hugo Grotius was a Dutch legal scholar whose 1609 book Mare Liberum promoted the idea that seas should be free for innocent use and benefit of all.

8 Pardo, The Common Heritage of Mankind, p. 2.

9 Interim Report on the United Nations and the Issue of Deep Ocean Resources, by United States Congress House Committee on Foreign Affairs Subcommittee on International Organizations, 90th Congress, First Session, 7 December 1967, p. 277.

10 Arvid Pardo was not person who coined the term ‘common heritage of mankind’ because it had already been used by Ambassador A.A. Cocca who was one of the prominent figures in the discussions on the common heritage of mankind and President Lyndon Johnson.

11 Christopher C. Joynor, ‘Legal Implications of the Concept of the Common Heritage of Mankind’, International and Comparative Law Quarterly, 35 (1986), 190–199 (p. 191).

12 Address given by President Lyndon Johnson at the commissioning of the vessel, U.S. NOAAOceanographer, 13 July 1966.

13 Ann L. Hollick, ‘US Oceans Policy: The Truman Proclamations’, Virginia Journal of International Law, 17:1 (1976), 23–55.

14 Barkenbus, Deep Seabed Resources, p. 4.

15 Pardo, The Common Heritage of Mankind, p. 31.

16 Barkenbus, Deep Seabed Resources, p. 5.

17 Ida Ryuichi, ‘Human Genome as Common Heritage of Mankind—with a Proposal’, Bioethics in Asia, 1.8 (1997). <http://www.eubios.info/ASIAE/BIAE59.htm> [accessed on 28 January 2000]

18 Jasper A. Bovenberg, Property Rights in Blood, Genes and Data: Naturally Yours? (Leiden: Martinus Nijhoff Publishers, 2006), p. 37.

19 Ibid., pp. 37-38.

20 Hugo Grotius, Freedom of the Seas: The Right of the Dutch to Take Part in the East Indian Trade, trans. by Ralph Van Deman Magoffin (New York: Oxford University Press, 1916), p. 6. <http://www.oll.libertyfund.org/EBOOKS/Grotius_0049.pdf> [accessed on 22 August 2006]

21 Ibid., p. 5.

22 Ibid., p. 13.

23 Ibid.

24The Institutes of Justinian, trans. by John Thomas Abdy and Bryan Walker (Cambridge: Cambridge University Press, 1876), pp. 82–85. [Inst. Iust. 2.1.12-18 (De Rerum Divisione)].<http://www.archive.org/details/institutesofjust00abdyuoft> [accessed on 11 April 2004]

25 Marjorie M. Whiteman, Digest of International Law, 15 vols (Washington D.C.: U.S. Government Printing Office, 1963–1973), II (1963), 1030–1232.

26 Pilar N. Ossorio, ‘The Human Genome as Common Heritage: Common Sense or Legal’, The Journal of Law, Medicine and Ethics of the American Society of Law, Medicine and Ethics, 35:3 (2007), 425–39.

27 Arvid Pardo, ‘The Law of the Sea: Its Past and Its Future’, Oregon Law Review, 63:1 (1984), 7–17.

28 Bovenberg, Property Rights in Blood, Genes and Data, p. 55.

29 Abdy, The Institutes of Justinian, pp. 78–80.

30 Pardo, The Common Heritage of Mankind, p. 7.

31 Ibid., pp. 18–19.

32 Bovenberg, Property Rights in Blood, Genes and Data, p. 57.

33 James D. Watson, The Double Helix: A Personal Account of the Discovery of the Structure of DNA (London: Weidenfield & Nicolson, 1968).

34 Francis H. C. Crick, Of Molecules and Men (New York: Prometheus Books, 2004), p. 19.

35 James D. Watson, The Molecular Biology of the Gene (New York: W.A. Benjamin, 1965), p. 67.

36 Leslie Roberts, R. John Davenport, Elizabeth Pennisi and Eliot Marshall, ‘A History of the Human Genome Project’, Science, 291:5507 (2001), 1195.

37 Final HGP papers were published in 2006. A high-quality ‘finished’ sequence of the human genome was completed in 2003. Involved in the HGP, besides the Department of Energy and the National Institutes of Health, were several researchers at numerous colleges, universities and laboratories throughout the United States that also received funding for human genome research. Many private companies also conducted research that contributed to the success of the HGP.

38 Bovenberg, Property Rights in Blood, Genes and Data, p. 37.

39 Antonio Regalado, ‘The Great Gene Grab’, Technology Review (September/October 2000), 49–50.

40 Ibid., p. 49.

41 l.J. Demaine and A. X. Fellmeth, ‘Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent’, Standard Law Review, 55 (2002), 303–462 (p. 328).

42 Kyle Jensen and Fiona Murray, ‘Intellectual Property Landscape of the Human Genome’, Science, 310 (2005), 239–40.

43 Ibid.

44 Ibid.

45 Lori B. Andrews, ‘Genes and Patent Policy: Rethinking Intellectual Property Rights’, Nature Reviews, 3 (2002), 803–08.

46 Brian Goldman, ‘HER2 Testing: The Patent “Genee” Is Out of the Bottle’, Canadian Medical Association Journal, 176 (2007), 1443–44 (p. 1444).

47 Ibid.

48 Emmanuel Agius, ‘Patenting Life: Our Responsibilities to Present and Future Generations’, in Germ-Line Intervention and our Responsibilities to Future Generations, ed. by Emmanuel Agius and Salvino Busuttil (Dordrecht: Kluwer Academic Publishers, 1998) pp. 68–69.

49 Ibid., pp. 73–74.

50 On 14 April 2003, in a joint proclamation by six heads of state comprising France, the USA, the UK, Germany and Japan and China, on the 50th anniversary of the discovery of the DNA double helix by James Watson and Francis Crick, it was stated that with the completion of the Human Genome Project, ‘all the chapters of the book of human life were complete’.

On 14 March 2000, in a Joint Statement by US President Bill Clinton and UK Prime Minister Tony Blair, it was declared that the ‘raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made available to scientists everywhere’.

51 Tanya Reimer, New Property and Global Governance: The Common Heritage of Mankind (submitted by Tanya Reimer on 24 April 2007 to Dr. O’Brien in partial completion of Global Governance), p. 5. <tanya.peatt.net/published/property_global_gov_chh.pdf> [accessed on 15 May 2007]

52 Ryuichi, ‘Human Genome as Common Heritage of Mankind’, pp. 59–63.

53 Pardo, The Common Heritage of Mankind, p. 31.

54 Robert Song, Human Genetics (Cleveland: The Pilgrim Press, 2002), p. 102.

55 Jeremy Rifkin, The Biotech Century: How Genetic Commerce Will Change the World (London: Phoenix, 1998), pp. 36–37.

56 Agius, ‘Patenting Life’, p. 69.

57 Martin Heidegger, ‘The Question Concerning Technology’, in Basic Writings, ed. by David Farrell Krell (London: Routledge, 1978), p. 318.

58 Bill McKibben, Enough: Staying Human in an Engineered Age (New York: Henry Holt and Company, 2003), pp. 88–92.

59 Heidegger, ‘The Question Concerning Technology’, p. 321.

60 Ibid., p. 320.

61 Martin Buber, I and Thou, trans. by Ronald Gregor Smith (Edinburgh: T&T Clark, 1999).

62 Charles Taylor, The Ethics of Authenticity (Cambridge M.A.: Harvard University Press, 1991), pp. 93–108.

63 Heidegger, ‘The Question Concerning Technology’, p. 321.

64 Buber, I and Thou, pp. 19–21.

65 Heidegger, Basic Writings, ‘The Question Concerning Technology’, pp. 323–24.

66 Michael E. Zimmerman, ‘Beyond “Humanism”: Heidegger’s Understanding of Technology’, in Heidegger the Man and the Thinker, ed. by Thomas Sheehan (Chicago: Precedent Publishing, 1981), p. 224.

67 Mahon O’Brien, Commentary on Heidegger’s ‘The Question Concerning Technology’, in IWM Junior Visiting Fellows’ Conferences, Vol. XVI/I, 2004.

68 Heidegger, Basic Writings, pp. 325–26.

69 Ibid., pp. 313–16.

70 Richard Polt, Heidegger (London: Routledge, 1999), p. 174.

71 Zimmerman, ‘Beyond “Humanism”’, p. 226.

72 Taylor, Ethics of Authenticity, pp. 93–108.

73 Ibid., p. 101.

74 Hans Jonas, The Imperative of Responsibility: In Search of an Ethics for the Technological Age (Chicago: University of Chicago Press, 1984), p. 23.

75 Richard Wolin, Heidegger’s Children (Princetown: Princetown University Press, 2001), p. 119.

76 Hans Jonas, ‘Wissenschaft as Personal Experience’, Hastings Center Report, 32:4 (2002), 27–35 (p. 34).

77 Jonas, The Imperative of Responsibility, p. 6.

78 Hans Jonas, Philosophical Essays: From Ancient Creed to Technological Man (Chicago: Chicago University Press, 1974), p. 6.

79 Ibid., p. 10.

80 Jonas, The Imperative of Responsibility, pp. 26–27.

81 Ibid., pp. 129–30.

82 Beginning in the summer of 1922, Heidegger occupied a small, three-roomed cabin overlooking the small mountain town of Todtnauberg, in the Black Forest.

83 Leon R. Kass, Life, Liberty and the Defence of Dignity: The Challenge for Bioethics (San Francisco: Encounter Books, 2002), pp. 219–39.

84 S. Gregory and others, ‘The DNA Sequence and Biological Annotation of Chromosome’, Nature, 441: 7091 (18 May 2006), pp. 315–321.

85 On 26 June 2000, President Bill Clinton at the White House and Tony Blair at 10 Downing Street simultaneously proclaimed the first draft of the Human Genome Project complete. <http://www.ornl.gov/hgmis> [accessed on 20 March 2006]

86 Bill Clinton and Tony Blair, Joint Statement by President William Clinton and Prime Minister Tony Blair of the United Kingdom (14 March 2000) <http://wwwipmall.info/hosted_resources/ippresdocs/ippd_44.htm, 14 March> [accessed on 20 March 2006]

87 Ibid.

88 Michael Polanyi, ‘The Republic of Science: Its Political and Economic Theory’, Minerva, I (1962), 54–74.

89 Taylor, Ethics of Authenticity, pp. 93–107.

90 Polanyi, ‘The Republic of Science’, pp. 54–74.

91 Ryuichi, ‘Human Genome as Common Heritage of Mankind’, pp. 59–63.

Chapter OneThe Human Genome—Common or Patentable Subject Matter?

1.1 The Human Genome as Common Heritage

While the application of the patent system in the field of biotechnology and biomedicine has seemed justifiable in the past as a way of ensuring a reasonable balance between the rights of inventors and the public interest, the granting of patents that assert rights over DNA sequences have raised special concern among individuals, scientists, national and international organizations. Most of these concerns have revolved around the idea that human DNA is of a special nature compared to the DNA of other organisms. Many are troubled by the idea that genes and their mutations can be subject to commercialization. Others are very concerned about the fact that the patent system in the field of biotechnology is in actual fact an impediment to the progress of scientific research with tragic consequences for healthcare.1 These same concerns have encouraged many to try to encourage the adoption of new legislation that would guarantee a more equitable and sustainable use of biotechnology. These concerted efforts have produced a number of notable results, including the Council of Europe Convention on Biomedicine2 with its related Protocol on Human Cloning,3 the Universal Declaration on the Human Genome and Human Rights4 with the related Declaration on Human Genetic Data,5 and the Declaration on Human Cloning.6 The Council of Europe’s Committee on Legal and Human Rights has also called on member states to change the basis of patent law with respect to rights of ownership over human tissue and genes into ‘law pertaining to the common heritage of mankind’.7

Expressing the same concerns and taking into account the fact that the EU Directive on the Legal Protection of Biotechnological Inventions8 was being challenged at the European Court of Justice by the governments of the Netherlands and Italy and that Norway was inclined not to implement it,9 the Parliamentary Assembly of the European Union found it expedient to recommend that member states should strive towards establishing a ‘World Patent Convention’ which would replace the present patent system that is considered to be inadequate for dealing with the discovery of human genes in particular.10 The Parliamentary Assembly also recommended that this proposed system should be founded on a principle of common heritage of mankind which should reflect the language of the Universal Declaration on the Human Genome and Human Rights.11

The Universal Declaration on the Human Genome and Human Rights was adopted unanimously and by acclamation by the General Conference of UNESCO on 11 November 1997, as a result of the urgent need felt by the international community to provide itself with an international instrument more particularly focussed on the human genome.12