by Chamundeeswari Kuppuswamy. London and New York: Routledge, Taylor & Francis Group, 2009. 210pp. Hardback. £80.00/$128.70. ISBN: 9780415458573.
Reviewed by Ricardo Chueca, Faculty of Law, University of La Rioja, Spain. Email: ricardo.chueca [at] unirioja.es.
THE INTERNATIONAL LEGAL GOVERNANCE OF THE HUMAN GENOME is not just the title of a book, it is also a proposal, a declaration of how things should be done in relation to such a complicated matter; in short, it is a challenge. In truth, the governance of the human genome does not exist as such. What exists, as the book painstakingly shows, is the efforts to make this possible. And, with exquisite care and minute detail, the book describes the steps taken. But at every stage, Chamundeeswari Kuppuswamy does not forget to recall, in a subtle manner, what is at stake. To this end, he also proposes the ways in which a framework could be created which would make such governance possible. There is a reason for this: the governance of the human genome is only possible if a single international legal framework exists. This is the goal towards which we must keep moving – but not at any price. An interdisciplinary focus is absolutely vital. And this requires lawyers to include in their analysis elements from other disciplines. This will make it possible to avoid redundant or premature legal discussions. An interdisciplinary approach, without doubt necessary, does not obstruct the application of legal frameworks adjusted to meet standards of justice and fairness.
Kuppuswamy proposes an approach to the human genome that builds directly on the foundations of human rights conceived in a universal and standard manner, a formulation of human rights that allows a new balance to be struck between private property and development. As the reader will be constantly made aware, such an approach is extremely ambitious, although not overly so.
The book is organised into six chapters, as described below.
In chapter one, ‘The human genome and bioethics,’ a description is given of the aspects differentiating human genome research from normal research practices in general, particularly those in the field of life sciences. The inclusion of scientists and technologists, together with clinical researchers, the central importance of computing and its close relationship with the handling of genetic information, the rapid appearance of ethical and legal problems – these are all factors that complicate the system through which the expected benefits of research are made available.
A metamorphosis has taken place in experimentation involving humans, accelerated by technological advances. This is so to such an extent that the original rules on such experimentation, the Nüremberg Code, rapidly became obsolete with respect to the new emerging scenarios. Kuppuswamy [*179] describes the different attempts to design new legal models and the problems associated with the use of nanotechnology and biotechnology. Equally, he explains the circumstances leading to the birth of bioethics associated with all of the foregoing, as well as its subsequent development as a result of the difficulties of adapting traditional human rights to these new scenarios.
“Protect and preserve” could be the motto used to describe the actions of various international organisations (UNESCO, the Human Rights Council, the European Union, the World Health Organization, the General Assembly of the United Nations, and so on) in relation to the human genome. But we do not know exactly what this means. In fact, as the Universal Declaration on the Human Genome and Human Rights states, we do not know much more than the fact that the human genome is the common heritage of mankind (CHM). Yet, freedom of research and intellectual property in relation to the results of such research have raised serious problems. “Intellectual Property (IP) is the proverbial elephant in the room in the Universal Declaration” (p. 29). In addition, there is the (unresolved) problem of opting to conceive of the human genome as the subject or the object of international law. Do we now know enough about the genome to be able to make a declaration about this? Kuppuswamy draws attention to the tendency to constantly associate the concept of Common Heritage of Mankind (CHM), which is perhaps a symbolic or even a rhetorical formulation, with that of intellectual property rights. He very clearly perceives this association as an objective threat to indigenous people in relation to their genetic singularities and the biodiversity of their environment.
The advances made by different international bodies, reflected in different legal documents, have revealed the existence of extremely delicate situations – discrimination on the basis of genetic inheritance; the use of such information in relation to insurance policies; rules to remove the protection of the privacy of a person or family group’s genetic information; the nature of intellectual property rights over the knowledge obtained, and so on.
The way that Kuppuswamy approaches the meaning and scope of the concept of CHM in international law is extremely interesting and original. Non-appropriation, international management, benefit sharing and peaceful use are the essential elements of CHM. He examines this concept in relation to plant genetic resources, where the tensions arising through the regulation of these matters are patent. What exactly this term means is extremely difficult to establish. In fact, article 1 of the UDHRHG contains more than one legal system, and in international law there is not a single accepted definition of CHM.
The method used by the author in chapter 3 is extremely illustrative, since it applies the four elements that define the CHM to the UN Convention on the Law of the Sea, the Moon Treaty and, finally, the human genome. In this latter case, Kuppuswamy argues that it is necessary to ensure access to the results of the research on the human genome to all peoples and all countries, particularly those that are under-developed. The [*180] meaning of the concept of CHM also implies that the benefits of the research into the human genome must be available to all human beings.
The human genome is the common symbolic heritage of humanity because, as can be seen from the travaux préparatoires of the Universal Declaration of 1997, human dignity is a characteristic of each human being. And this is so because the genome is a unique human resource. It is precisely this fact that differentiates it from the international regulation of property in the seabed or celestial bodies. In its natural state, the human genome belongs to everyone (a res omnium), in the way that Grotius established for the CHM. Ultimately, the human genome in its natural state refers to the total genome of the human body. And since it involves a discovery rather than an invention, it cannot be the subject matter of acts whose goal is to obtain an economic benefit, which would remove it definitively from the legal sphere of patents. The CHM, like human dignity, is on the one hand, a common heritage, yet, on the other, the fact that individual genes are at the same time the subject matter for disposal by their individual owner and the common heritage of humanity must be recognised.
In chapter 4 Kuppuswamy tackles the problem of the connection between the CHM and the right to development (RTD). The origins of the RTD can be found in the movement of unaligned countries. The author maintains that the RTD is effectively a human right in that it forms part of the right to health. In this way, the RTD is present in the governance of the human genome through the Declarations on the Genome of 1997 and 2005. It is true that the RTD is also presented as a moral right. But the material connection in terms of legally protected property does not guarantee the connection as rights. The RTD would include “the full sovereignty over natural resources, self-determination, popular participation in development, equality of opportunity and the creation of favourable conditions for the enjoyment of other civil, political, economic, social and cultural rights” according to the Declaration on the Right to Development of the United Nations (1986). In this regard, the book alerts us to the abyss that we could fall into, namely the evidence that the new scenarios for the human genome, in the context of the current imbalances in terms of underdevelopment, may lead to a world irreversibly split into those that are dominant and those that are dominated. Or perhaps this process is already taking place.
In chapter five, Kuppuswamy constructs a premise from a moral perspective, based on the theories of Gewirth, particularly his Principle of General Consistency, which he meticulously develops and explains.
Applying this theory, Kuppuswamy builds a specific relationship between human rights, common heritage and development. This involves placing the RTD within the framework of the CHM concept in order to join together the idea of economic interest with that of human rights, so that a “pragmatic approach to health” can be obtained. Such an approach is in line with the systems of fundamental rights, but not that of human rights as these are contained in the constitutional systems of the Continental European model. The [*181] fundamental difference is that in such systems, individuals possess a right, which can be invoked before a court, to obtain the corresponding benefit. However, these same states – together with others that do not offer such a possibility – do not interrelate with each other in a similar manner in the international sphere. Human rights, however fundamental (important) they may be and fundamental rights (that can be relied on in domestic law before a court) belong to substantially different legal spheres. Accepting a human right as a right that can be invoked by states, is at present, an act of sovereignty, irrespective of the importance, or moral necessity, of the human right to health. That said, there is nothing wrong with trying to overcome this model of international law, given the need to overcome morally unjust situations that are now reaching the limits of what is socially and politically unbearable.
The twenty-first century was quickly termed the century of biology. Logically, we will have to wait a few years to see whether this is indeed the case. What is beyond doubt is that it is now necessary to establish certain stable principles governing relations between international law, human rights, health, development and property, particularly intellectual property. Above all, it is necessary to define the terms of the relationship between the common heritage of mankind and intellectual property rights. Kuppuswamy describes an analytical framework of great quality, one that reveals his excellent understanding of fundamental aspects of international law and the way that pharmaceutical and biotechnological research works. Genomics and biotechnology are technology-driven and patent-oriented research fields. This fact is undeniable.
“The two sides of the coin in IP,” says Kuppuswamy, “include protection of producers’ interest and the consumers’ interests. On the one hand monopoly rights are granted to inventors who create new ideas and objects; on the other hand society derives benefit from such creation. The requirement of disclosure is important – otherwise society cannot derive benefit from such a creation. However does the society’s benefit lie narrowly in disclosures, or should the creations be beneficial to that society and in that time, by being responsive to the needs of the society?” Is it possible to have legal ownership of the knowledge obtained in systems where research is not structured in an individualistic manner? This issue is examined in great detail in the International Bioethics Committee document of 2002 in relation to IPR.
Kuppuswamy draws attention to the fact that what we call bioproperty does not fit well into the traditional concept of property. The importance of intellectual property in human genome research largely transforms the very idea of traditional property. Perhaps the author is overoptimistic when he states that the idea of property with respect to biological objects has been redefined. Perhaps it might be more correct to state that it should be redefined. Although it is true that it is in crisis.
Nevertheless, despite the difficulties existing (which are not concealed), Kuppuswamy believes it possible, taking the concept of CHM as a starting point, to build an IPR system capable of integrating both private and public [*182] interests, one that creates a new balance that is compatible with the universalisation of the benefits of biotechnology and genomics research. In his opinion, international law offers techniques and mechanisms to enable the construction of an International Legal Governance of the Human Genome.
After finishing this book, the reader will be aware of all the obstacles in the way of achieving this goal. Yet for mysterious reasons that he will be unable to explain, he will not completely abandon the idea that it can be achieved, or may be one day.
© Copyright 2010 by the author, Ricardo Chueca.