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Genscheren-Verfahren wie CRISPR/Cas9 und andere neue genomische Techniken (NGT) im Rechtsetzungsvorhaben der Europäischen Union

Im Jahre 2020 wurde der französischen Forscherin Emmanuelle Charpentier und der US-amerikanischen Wissenschaftlerin Jennifer Doudna für die Entdeckung und allgemeinen Nutzbarmachung der Genschere CRISPR/Cas9 der Nobelpreis für Chemie verliehen.

CRISPR/Cas9 and similar genome editing technologies - also called 'new genomic techniquesâ€� (NGT) - are about to play a key role in the field of genetic designing of plants. However, in the European Union the regulation of NGT and their application in green genetic engineering is based on legislation of the early 2000s and the following jurisprudence of the European Court of Justice. Considering the subsequent breakthroughs in genome editing, the current normative framework seems increasingly outdated and not sufficiently adapted to the vast scientific progress. Additionally, the application of NGT is so far quite restricted as well as regulatorily undifferentiated and hence a strategic disadvantage for research and private enterprises in the EU. On the other hand, the risks of their application are still subject to ongoing scientific evaluation and can't be promptly forecasted.
The European Commission has reacted to these circumstances with a draft of an NGT regulation, that has just been adopted under some changes by the European Parliament. Although there are still steps to be taken in the legislative process, it becomes increasingly likely that this draft will be transformed into legal action in the upcoming time. This paper aims to explain the scientific bases of and around the focal technique CRISPR/Cas9 and analyzes the key legal parameters of the given regulative draft. Eventually, it will also convey new concepts and further ideas for the regulation of genomic technologies.

Copyright:	© Lexxion Verlagsgesellschaft mbH
Quelle:	EurUp 03/2024 (August 2024)
Seiten:	17
Preis:	€ 32,00
Autor:	Prof. em. Dr. Michael Kloepfer
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