REPORT
on the ethical, legal, economic and social implications of human genetics
Temporary Committee on Human Genetics and Other New Technologies in
Modern Medicine

http://ec.europa.eu/research/biosociety/pdf/pe_genetics.pdf

N1541_the ethical, legal, economic and social implications of human genetics.pdf

[목차]

EXPLANATORY STATEMENT ... 33
I. Introduction ... 33
II. Human genetics: a scientific and technological challenge amounting to nothing short of a
revolution ... 34
II.1. DNA – Genes – Chromosomes ... 35
II.2. Chromosomes ...37
II.3. Genetic diseases ... 37
II.4. The function of genes...41
II.5. Consequences of the Human Genome Project... 42
III A working method in support of an ‘integrated approach’ to promote a new relationship
between science and technology... 43
IV Powers and responsibilities of the EU in the field of human genetics ... 45
V. International and European legal instruments ... 49
VI. Work programme... 53
VI.1. Genetic tests...53
VI.1.1 Ethical and social implications of genetic tests ... 54
VI.1.2 Legal and regulatory implications of genetic testing... 57
VI.2 Care approaches to genetic diseases: treatments (therapy and medicine) ... 58
VI.2.1 Gene therapy ...58
VI.2.2 Genetic medicine ...59
(a) Medicines obtained from transgenic animals ... 59
(b) Tissue and organ transplants... 59
(c) Pharmacogenetics ...62
VI.2.3 Ethical and social implications ... 63
VI.3 Avenues to explore for Community action providing value added ... 66
VI.4 Economic implications of human genetics (diagnosis and therapy) ... 68
VI.4.1 Situation of the European gene therapy sector ... 69
VI.4.2 National and European gene therapy research output ... 71
VI.4.3 To what extent does gene therapy constitute an explicit priority in the national
systems used to fund science? ... 72
VI.4.4 Avenues to explore for possible recommendations to the Member States ... 73
PE 300.127/fin. 4/118 RR/453921EN.doc
EN
VII. The use of genetic information ... 73
VIII The patentability of living matter ... 74
VIII.1 Legislative frame of reference at Community level ... 75
VIII.2 Patented innovation as a driving force of research ... 76
VIII.3 Directive 98/44/EC on the legal protection of biotechnological inventions ... 77
VIII.4 Human genome ... 79
VIII.5 Patentability of gene sequences ... 80
VIII.6 Arguments for and against the patentability of genes ... 82
IX. The sixth research framework programme ... 84
X. Conclusions: what should be the role of the Union? ... 86