REGULATORY ASPECTS OF GENOMICS, GENETICS AND BIOTECHNOLOGY:
An Orientation on the Positions of Germany, the United Kingdom and the United States

The human genome that is inside the nucleus of every cell of the human body contains codes that form a blueprint for the entire human being. In recent years, these DNA codes have to very large extent been uncovered. Within the framework of the so-called Human Genome Project, important work has been carried out in this respect. The next step will be to grasp the meaning of the codes. Biotechnologists are only beginning to understand the codes, although they are making good progress and have already a profound understanding of the ‘meaning’ of some small, isolated parts of the genome. The knowledge about the genome opens up unprecedented possibilities. The progress of life sciences has, e.g., brought knowledge about genetic predispositions, early diagnosis and even ‘diagnosis’ before a condition shows itself. It will, e.g., become possible to mend defective genes (aka genetic therapy) and to improve xenotransplants. Furthermore, life sciences are not confined to the human genome; they also focus on animal and plant genomes. The knowledge in these fields has even led to technically further reaching applications, such as genetically modified (GM) food, such as GM soybeans and GM maize, which is resistant to, e.g., damaging insects and plant diseases. As a last example, the cloning of animals such as the – already dead – sheep ‘Dolly’ can be mentioned.

The new knowledge and its applications are bound to give rise to legal questions. The purpose of this article is to provide an insight into the legal questions that arise as a consequence of the developments described above. In order to gain a first understanding of the questions that have already been raised, the laws in Germany, the United Kingdom and the United States have been studied. Furthermore, it has been investigated whether these questions exhibit a need for legal intervention. In this respect the authors have discerned four themes that may serve as a basis for structuring the discussion about intervention.

1. Introduction

2. Legal implications: A first impression of the key issues at stake

2.1 Introduction

2.2 Genetically modified material: The environment

2.3 Genetically modified material: Food and feed

2.4 Genetic research

2.5 Human genetics

2.5.1 Genetic testing

2.5.1.1 The decision to undergo a genetic test

2.5.1.2 Access to the results of genetic testing

2.5.1.3 Use of the results of genetic testing

2.5.2 Genetic therapy

2.5.3 Cloning

2.5.4 Research on human genetics

2.6 Patent protection

3. National legal measures and developments

3.1 European developments regarding the environment and products

3.2 European developments regarding patent protection

3.3 Germany

3.3.1 General

3.3.2 Environment and products

3.3.3 Animals

3.3.4 Human genetics

3.3.4.1 Genetic testing

3.3.4.2 Cloning

3.3.4.3 Research

3.3.5 Patent law

3.4 The United Kingdom

3.4.1 General

3.4.2 Environment and products

3.4.3 Human genetics

3.4.3.1 Genetic testing

3.4.3.2 Cloning

3.4.3.3 Research

3.4.4 Patent law

3.5 The United States of America

3.5.1 General

3.5.2 Environment and products

3.5.3 Human genetics

3.5.3.1 Genetic testing

3.5.3.2 Cloning

3.5.3.3 Research

3.5.4 Patent law

4. Synthesis

4.1 Structuring the field

4.1.1 Safety risks

4.1.2 Individual autonomy, responsibility and privacy

4.1.3 Access and property

4.1.4 Integrity and intrinsic value

4.2 The form of legal intervention

4.2.1 Risk prevention

4.2.2 Individual autonomy, responsibility and privacy

4.2.3 Access and property

4.2.4 Protecting integrity and intrinsic value

4.3 The involvement of society

5. Conclusion

Notes