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Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts
Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plant...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4903111/ https://www.ncbi.nlm.nih.gov/pubmed/27142995 http://dx.doi.org/10.1007/s00299-016-1990-2 |
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author | Sprink, Thorben Eriksson, Dennis Schiemann, Joachim Hartung, Frank |
author_facet | Sprink, Thorben Eriksson, Dennis Schiemann, Joachim Hartung, Frank |
author_sort | Sprink, Thorben |
collection | PubMed |
description | Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system. |
format | Online Article Text |
id | pubmed-4903111 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-49031112016-06-27 Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts Sprink, Thorben Eriksson, Dennis Schiemann, Joachim Hartung, Frank Plant Cell Rep Opinion Paper Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system. Springer Berlin Heidelberg 2016-05-03 2016 /pmc/articles/PMC4903111/ /pubmed/27142995 http://dx.doi.org/10.1007/s00299-016-1990-2 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Opinion Paper Sprink, Thorben Eriksson, Dennis Schiemann, Joachim Hartung, Frank Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
title | Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
title_full | Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
title_fullStr | Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
title_full_unstemmed | Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
title_short | Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
title_sort | regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts |
topic | Opinion Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4903111/ https://www.ncbi.nlm.nih.gov/pubmed/27142995 http://dx.doi.org/10.1007/s00299-016-1990-2 |
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