Book Reviews
Genetics and Gene Therapy & Biotechnological Inventions: Moral Restraints and Patent Law
Sheila AM McLean (ed)
ISBN: 0-754620-55-7 2005 xxxi+535 HB pages Aldershot: Ashgate
Peter Glasner
Professorial Research Fellow, ESRC Centre for the Economic and Social Aspects of Genomics, Cardiff University, Cardiff, UK
These two books share an underlying theme that the role of law in the development of new genetic technologies is to be facilitative as well as regulatory. The collection edited by Professor Sheila McLean contains 24 papers published recently, mainly from international law and bioethics journals. This collection forms part of Ashgate's International Library of Medicine, Ethics and Law. The book is divided into two equal parts, with the first focussing on a general discussion about the genetic enterprise as a whole, and the second on cutting edge debates in genetics such as cloning and gene therapy. Part one starts with several papers by lawyers and bioethicists. They begin by discussing law and regulation, before moving on to talk about the (mis)use of genetic information and the possibilities of discrimination, especially with regard to race and gender. The chapters then address the effects on kin networks of genetic information about individuals, on privacy more widely, and on genetic testing in the workplace. Finally, this section ends with a paper on pharmacogenetics and healthcare. Part two covers 'practical' genetics seen as the future applications of genetic knowledge to the creation, manipulation and enhancement of human beings. It begins with a discussion of pre-implantation genetic diagnosis, and predictive genetic testing for early childhood conditions, followed by papers on genetic modification and enhancement. The last seven contributions explore the debates about human cloning and stem cell therapy.
The introduction by McLean is a thorough summary of the book's contents and illustrates clearly the importance and significance of the topics under discussion. It does not, however, go further than the stated aim to suggest that the law should be formulated in such a way as to facilitate the development of the new genetics, and so fails to take issue with the debates it describes. This leaves the reader with no clear view as to why these particular papers were chosen, or indeed, what has been left out and why. The lack of a concluding chapter further limits the usefulness of this volume to anyone not already closely familiar with the field. However, to those researchers and teachers looking for a 'one stop shop' of current debates in a contentious new area spanning medicine and the law, this book brings together many of the key contributions. It is a pity, for this ageing reviewer at least, that the contributions are reproduced in the format of the journals from which they were abstracted. This results in an untidy and uneven appearance, and in the case of those articles printed in two columns, some difficulty in reading the text.
The monograph by Dr Oliver Mills takes a closer look at one of the areas of controversy mentioned only briefly in the McLean collection, namely patenting biotechnological inventions. It is Mills' contention that by elucidating moral concerns associated with the new genetic technologies, we will better understand and identify their associated benefits. This in turn will allow us to make better-informed decisions about the role of the law. He argues that modern biotechnology poses a significant challenge to patent law in particular, because it was developed to deal solely with mechanical inventions. The commercial applications of modern biotechnology in healthcare, agriculture and the food industry have resulted in a plethora of patent applications that fall outside this restricted scope. Scientists, he rightly notes, are no better equipped than anyone else to identify the social and moral issues all this raises.
Mills then focuses on developments in the European community, and compares practices there with those in the USA. Article 53 of the European Patent Convention of 1973 provides that patents should not be awarded to innovations that are likely to be contrary to public order or morality. The heart of the book analyses how Europe has been attempting to harmonise its patent legislation since 1973 and particularly through the Biotechnology Directive of 1998. Mills argues that patent law should not be designed to regulate the growth of biotechnology in Europe through appeals to morality rather than to economics, and looks to the United States where morality as a ground is excluded. There the role of patent legislation is much clearer than in Europe, and the courts rather than the legislature are seen as the arena within which patent disputes are resolved. The European Union has, in the view of the author, much to learn from its American cousins.
The strength of this monograph lies in its detailed account of patent law harmonisation in Europe, and how morality continues to play a significant role in the process. Further, it encompasses a much broader understanding of the new genetic technologies than the previous volume by discussing agriculture and food as well as health and healthcare. However, it underplays the silent but still present role that morality plays in US patent law and its unfettered laissez-faire approach. This is best understood when the wider economic context (particularly in 'green' biotechnology) is brought into the discussion. Patent law is more than simply an instrument of economic policy, as witnessed by the very diverse views on genetically modified organisms held on either side of the Atlantic and between the rich and the poorer nations of the globe. It is, after all, no coincidence that the largest proportion of biotechnology patents are held by a very few US-based companies. Nor is it enough to point to the US courts as taking forward conflict resolution in this contentious area, without recognising that litigation has proved to be so costly and protracted that only the wealthiest and largest corporations have stayed the course. However, this book is generally successful in dealing with a complex and still evolving area and, while providing sufficient detail to satisfy the legal expert, also makes an accessible introduction to anyone working in the field who wishes to understand the current state of play.
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