Biotechnology, Patents and Morality

Sigrid Sterckx

• Publisher: Taylor & Francis
• Year: 2017
• eBook ISBN: 9781351744218
• Edition: 1
• Topic: Sozialwissenschaften
• Subtopic: Soziologie

This title was first published in 2000. This work documents an international and interdisciplinary workshop on the ethical aspects of the patenting of biotechnological inventions, including genes, plants and animals. The public perception is discussed, along with how these perceptions relate to ethical, social and cultural factors. The legal framework in Europe is laid out by several experts in the field of patent law and the situation in the US is also briefly described. This edition also includes a general discussion of three important theories called upon to justify the patent system: the natural rights argument; the distributive justice argument; and the utilitarian argument. The chapter about the European Directive on the legal protection of biotechnological inventions has been updated. A selection of provisions from the August 1997 draft as well as the final text of the Directive, as adopted on 12 May, 1998, are discussed and commented upon. The patent provisions of the TRIP's Agreement (the Agreement on Trade Related aspects of Intellectual Property rights, concluded in 1994 as an Annex to the Agreement Establishing the World Trade Organization) are also discussed and criticized, paying particular attention to the implications for biotechnology patents. Finally, the question is asked whether the developing countries stand to gain anything from TRIPs. A look at the results of empirical research, conducted by commentators on the economics of patenting, reveals that the new patent regime may prove to entail significant costs for the developing countries. This second edition also contains material on the EU Directive on biotechnology patents adopted in May 1998, justificatory theories of the patent system and the TRIP's agreement on Trade Related aspects of Intellectual Property rights, concluded in the GATT (WTO) framework.

1	European patent law and biotechnological inventions Sterckx Sigrid

Biotechnology

‘Biotechnology’ refers to a wide range of techniques that make use of living organisms. Although this term does not occur until the beginning of the 1970s, such techniques have been used for centuries. The making of cheese, the fermentation of wine and the breeding of plants and animals are examples of biotechnologies man has been applying for more than 5000 years. Until some two decades ago, however, the characteristics of living organisms could only be modified by means of gradual selection. The genes that had to cause a modification of a particular organism could only be chosen from the ‘pool’ of genes of the particular species this organism belonged to. At the beginning of the 1970s, a number of subsequent technological breakthroughs¹ created fundamentally new possibilities that marked the era of modern biotechnology.² When scientists unraveled the genetic code, they paved the way for genetic engineering. All living beings seemed to possess the same kind of hereditary ‘building blocks’, situated in the same molecule (DNA). Consequently, it had to be possible to ‘exchange’ this genetic material between different kinds of organisms. Indeed, in 1973 it was shown by Cohen and Boyer that DNA of different species could be assembled and subsequently inserted into a bacterium that served as a host cell. To ‘cut out’ particular pieces of DNA, they used restriction enzymes, which had been discovered earlier. This high-technological ‘cutting and sticking’, called ‘recombinant DNA-technology’ or ‘genetic engineering’, allows the combining of genes of totally different organisms with the purpose of introducing new properties into the receiving organisms. An example of the genetic engineering of animals is the modification³ of certain genes of these animals in order to render them capable of producing particular substances which are normally not produced by these animals. Some animals, plants and micro-organisms are used as so-called ‘bioreactors’ for the production of rare pharmaceutical substances. Human insuline and growth hormone, for example, are being produced by micro-organisms for several years.

Organisms whose genetic material has been modified through these kind of techniques are called ‘transgenic’ organisms. Several transgenic plants and animals have already been created. The main commercial applications of genetic engineering are in the fields of health care, agriculture and the food industry.

The widening of the debate

The debate about the legal, ethical and social problems connected with modern biotechnology has been on-going since this branch of technology came into being. One of the most persisting and important issues of the debate concerns the risks of genetic engineering to man and the environment. Since the organisation of the Asilomar conference in 1975, where scientists devised the first regulatory framework for the careful handling of genetically modified organisms (GMO’s), a public debate about the assessment of these risks has developed.

In discussions about the possibilities of modern biotechnology, very often ethical considerations are brought into the picture, especially when techniques are concerned that are meant to be applied to human beings. Only too often, George Orwell and the Nazi’s are brought into the debate. We agree with the assertion that, whenever possible, science should develop ‘hand in hand’ with ethics. However, we are opposed to an exaggeration of the possibilities of science with the purpose of causing fear and rejection of certain branches of science among the public. Unfortunately, such attempts to ‘inform’ the public are sometimes made with respect to biotechnology. Justified remarks concerning hazardous developments are used by some people to make biotechnology as a whole appear in a bad light. Biotechnology gives rise to very differing attitudes: some describe it as the ultimate means to solve all the major problems our society is struggling with. Others consider biotechnology to be the proof that humankind is digging its own grave.

Often, objections to modern biotechnology are confronted by the statement that there is no relevant difference between traditional biotechnology and modern biotechnology. Lord Howie, for example, who conducted an investigation in the United Kingdom in which he pleaded for a relaxation of the regulations in the field of biotechnology, stated that ‘Biotechnology is no more than an enhancing of the evolutionary process.’ Others consider biotechnology as an ‘acceleration’, instead of an ‘enhancement’ of natural processes:

… when Charles Darwin writes, of a certain Mr Wicking, that he took just “thirteen years to put a clean white head on an almond tumbler’s [a variety of pigeon] body” … what does the genetic engineer do but change the thirteen years that Darwin mentions to thirteen months?⁴

The great number of scientific advances which were achieved during the past decades in molecular and cellular biology have laid the foundations of the biotechnology industry as we know it today. Hundreds of companies have been set up, with activities in the fields of agricultural biotechnology, environmental biotechnology and biomedical applications of biotechnology. In environmental biotechnology, micro-organisms are modified with the purpose of being used to clean up soil, water and air. Agricultural biotechnology applies recombinant DNA technology to develop new techniques of plant and animal breeding and to change the properties of plants and animals. Among the transgenic plants that have been developed up to now are transgenic tomatoes, potatoes, sugar beets and tobacco. Often, the reason why crops are genetically modified is to make them resistant to insects, fungi or herbicides. Whereas the production of insect- and fungal resistant crops appears to be a beneficial development from an ecological point of view, the genetic modification of plants to make them herbicide-resistant is considered by many as undesirable because they believe this will lead to an increase instead of a diminishment in the use of herbicides. Many transgenic animals have been developed as well. The technique most frequently applied in this respect consists in the microinjection of DNA into newly fertilised eggs. The aim is to integrate the inserted DNA into the genome of the animal. If the integration is successful, the DNA will also be passed on to the progeny of the animal. This micro-injection has been done for the first time in 1980 with mice — in the mean time, hundreds of strains of transgenic mice have been developed. Mice are said to be cheap and easy to work with and the functioning of their genes is better known than that of higher mammals. The micro-injection technology has subsequently been utilised to produce among others transgenic amphibians, fish, rabbits, rats, poultry, cattle, goats, sheep and swine. A great number of transgenic mammals serve as models for the study of genetic diseases. Scientists apply the resulting insights to try to understand the development of diseases in humans and to design strategies for therapy. Possible treatments are tested on these animals. Other transgenic animal models have been generated for studying resistance to animal disease. Transgenic animals are also used as ‘factories’ for the production of valuable human and animal protein products which cannot be produced in bacteria (cf ‘molecular farming’, the use of animals as so-called ‘bio-reactors’).

In the domain of health care, biotechnology is used to produce medicines for diseases such as cystic fibrosis, various cancers and hemophilia. A wide gamut of diagnostic kits are also developed with the aid of biotechnology. An area that is still in its early stages, but considered by many as very promising, is the so-called ‘gene therapy’. In this field, attempts are made to correct congenital disorders.

When reviewing critiques of biotechnology, it must be kept in mind that some critics condemn biotechnology as such, whereas others make nuances in their arguments, depending on the kind of organism involved. For instance, some people feel that the genetic modification of micro-organisms is acceptable, whereas interventions in the genome of plants, animals and human beings are not.

Critiques of biotechnology as such

A few examples of frequently mentioned critiques of biotechnology as such are that man should not tinker with genes because:

– the gene pool is the joint property of the entire human race (cf the concept of ‘common heritage of mankind’) and therefore it should be passed on unchanged to following generations

– in doing this, man is ‘playing God’

– in doing this, man is playing ‘Mother Nature’

Some critics state that the results achieved in the field of biotechnology are not relevant enough for society as a whole. In this respect, it is noteworthy that, very often, it is difficult to balance the positive effect of a biotechnological invention on society’s well-being on the one hand and the risks of that invention to man and his environment on the other hand. The main reason for this difficulty is that, in many cases, the risks involved may only become apparent in the long term.

Another general critique is that, due to a lack of public control of the research in the domain of biotechnology, decisions as to which kinds of research are ethically acceptable are made by scientists, who are ill-suited for tackling ethical questions.

Critiques depending on the kind of organism involved

Some critics take into account the kind of organisms involved in biotechnological research. The arguments they use to assess, for example, genetic modification of plants, are different from the criteria applied to evaluate transgenic animals. They do not make statements about the merits and deficiencies of biotechnology as such.

Micro-organisms Regarding micro-organisms, attention is especially drawn to the risk of genetically modified micro-organisms ‘escaping’ from laboratories and spreading into our environment. Of course, some organisms are genetically modified with the very purpose of releasing them into the environment. For both these cases, regulations have been devised.⁵

Plants Regarding plants, a similar warning is expressed about the danger of disrupting ecological balances through the introduction and uncontrolled release of genetically modified plants into the environment.⁶ In this respect, it is sometimes said that experts in the field of genetic engineering are inclined to reason in terms of the individual organism that results from the introduced genetic modification (‘if the organism is harmless, there is nothing to worry about’). Some critics disagree with this way of reasoning: they assert that the effects of a transgene organism on its environment (including all the other organisms living in that environment) should be taken into account. They immediately add, however, that it is very difficult to assess those effects, for we are dealing with new organisms, i.e. organisms that did not exist before.

Another frequently heard objection to the genetic modification of plants is that it causes a reduction of biodiversity, for in the long term only plants with ‘interesting’ characteristics — i.e. characteristics that serve the interests of man — will remain. This kind of objection has been formulated, for instance, as follows:

A further source of concern and possible constraint centres upon the cumulative effect of genetic engineering on genetic diversity. There are at least two ways in which genetic engineering might contribute to the loss of genetic diversity … One is through the extensive use of cloning, where space which could have been occupied by a genetically distinct individual is occupied by an individual who is simply a genetic copy of another. The other way in which genetic diversity might be lost arises from the fact that genetic engineering will inevitably reflect human priorities, and human priorities are inevitably parochial. Life-forms which are in any way serviceable to humans will be developed in those respects in which they are serviceable and, in general, genes which express such properties will be favoured at the expense of those which do not.⁷

Representatives of the biotechnology industry reply to this objection by stating that, instead of reducing it, genetic engineering leads to more genetic diversity. In the context of the opposition that was filed by Greenpeace Ltd to a patent granted to the Belgian company Plant Genetic Systems, Greenpeace’s statement that genetic engineering reduces biodiversity was answered as follows by the patent holder:

… making non-plant genes available in plants, can increase genetic diversity.⁸

Animals Part of the objections to the genetic modification of animals run parallel to the observations that are made regarding plants. Here too, attention is drawn to the danger of disruption of ecosystems caused by the deliberate introduction of transgenic animals into the environment or their escaping from laboratories. Here too, it is said that the effects of the interaction between these animals and the environment in which they are released are often disregarded. The objection concerning the reduction of genetic diversity — only animals with characteris...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Dedication
• Table of Contents
• List of contributors
• Foreword by Etienne Vermeersch
• Preface
• Acknowledgements
• Preface to the Second Edition
• 1 European patent law and biotechnological inventions
• Part One: Biotechnology: Scientific aspects
• Part Two: Public perception of biotechnology 141
• Part Three: Ethical, social and cultural aspects of the biotechnology debate
• Part Four: Legal framework: Patentability in Europe and the US 195
• Part Five: The case for and against the patenting of biotechnological inventions
• Part Six: The debate
• Part Seven: Comments and conclusions