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

[인간유전학의 법적, 사회적 문제 등에 관한 유럽의회 보고서]

 N1530_인간유전학의법적,사회적문제등에관한유럽의회보고서.doc

Rapporteur: Francesco Fiori

[목차]

PROCEDURAL PAGE............................................................................................................... 5

MOTION FOR A RESOLUTION.............................................................................................. 6

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

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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

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 xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />Union?............................................................. 86