A Comparative Review of New Developments
Edited by Emanuela Arezzo and Gustavo Ghidini
Chapter 9: A Decade After the Birth of the Biotech Directive: Was it Worth the Trouble?
Sven J.R. Bostyn INTRODUCTION Directive 98/44/EC on the legal protection of biotechnological inventions (hereinafter the biotech directive)1 passed the legislative process somewhat more than a decade ago. This tenth anniversary of the biotech directive in 2008 was celebrated, if at all, without pomp and circumstance; to be more precise, it happened in absolute silence. The biotech directive, which has witnessed a lot of controversy and caused a considerable amount of turmoil, was nothing that the European Union saw as a reason for celebration or as a moment of retrospective reflection. In what follows, we will analyse what has become of the directive and whether it has indeed been worth the considerable trouble of passing it through the legislative process. Whatever one may think, it cannot be denied that the biotech directive has not been an unequivocal success. This recent tenth anniversary of the biotech directive offers a good opportunity to look back into the directive, and make an evaluation of its strengths and weaknesses and its interpretation problems upon implementation. What can be said from the outset is that the evaluation will be of a mixed nature. The biotech directive is to be lauded for a number of realizations, but must also be criticized for a number of other provisions. Maybe some had hopes higher than justified, not least the European Commission itself, when the directive was created. One of the strengths of the directive is the fact that it has made certain choices in areas which were up...
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