The Development of Regulatory Standards for Gene Therapy in the European Union
![handle is hein.journals/frdint18 and id is 1325 raw text is: THE DEVELOPMENT OF REGULATORY STANDARDS FOR
GENE THERAPY IN THE EUROPEAN UNION
Charles F. DeJager*
INTRODUCTION
In the more than forty years since James Watson and Francis
Crick discovered the structure of Deoxyribonucleic Acid'
(DNA) in 1953,2 researchers have made formidable advances
in molecular genetics.3 Scientists have accumulated enough
knowledge to begin to apply in human subjects the techniques
of genetic manipulation4 developed in animal trials.5 This tran-
sition has opened a new field of research that is at once promis-
* J.D. Candidate, 1996, Fordham University. The 1994 MCI-Fordham
International Law Fellowship generously funded the research for this Note. The
Author would like to thank Ms. Isabelle Arnal, Secretary, European Union Ethical
Committee on Biotechnology.
1. JAMES D. WATSON, THE DOUBLE HELIX: A PERSONAL AccouNT OF THE DIScovERY
OF THE STRucruRE OF DNA (1968) [hereinafter WATSON, THE DOUBLE HELIX]; James D.
Watson & Francis Crick, Genetical Implications of the Structure of Deoxyribonuceic Acid, 171
NATURE 964 (1953). Deoxyribonucleic Acid is a type of nucleic acid found principally
in the nuclei of animal and vegetable cells that is considered to be the repository of
hereditary characteristics. Id.
2. See WATSON, THE DOUBLE HEtLX, supra note 1 (including basic scientific back-
ground).
3. LouisJ. Elsas II, A Clinical Approach to Legal and Ethical Problems in Human Genet-
ics, 39 EMORY L.J. 811, 812 (1990) [hereinafter Clinical Approach]; seeJAMEs D. WATSON
ET AL., RECOMBINANT DNA (2d ed. 1992) [hereinafter RECOMBINANT DNA] (describing
advances in genetic research).
Even though genetic counseling and prenatal diagnosis are invaluable for fam-
ilies who are known to have an inherited disorder, there exists a long-cher-
ished hope that patients already afflicted might be treated by replacing their
defective gene with the normal gene. For many years this project seemed to
be very remote, more aptly belonging to the realms of science fiction. Only
with the application of recombinant DNA techniques to human genetic dis-
eases did research to develop practicable methods of gene therapy become
possible.
Id. at 567.
4. David A. Kessler et al., Regulation of Somatic-Cell Therapy and Gene Therapy by the
Food and Drug Administration, 329 NEw ENG. J. MED. 1169 (1993) [hereinafter Kessler,
Regulation].
5. See id. at 1171 (discussing testing in animals in investigational phases of gene
therapy); John C. Fletcher, Moral Problems and Ethical Issues in Prospective Human Gene
Therapy, 69 VA. L. REv. 515, 528-29 (1983) [hereinafter Fletcher, Moral Problems] (dis-
cussing widely-accepted practice of experimentation on animals to assess risks and ben-
efits of experimentation on humans).
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The Development of Regulatory Standards for Gene Therapy in the European Union
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