On July 25, the Court of Justice of the European Union (CJEU) ruled that organisms obtained through mutagenesis (using genetic editing techniques such as CRISPR, among others) constitute Genetically Modified Organisms (GMOs) and would be subject to the obligations established in Directive 2001/18/EC on GMOs.
The ruling may represent a setback for genomic editing techniques such as CRISPR, and thus, from BIOVEGEN, and within the framework of the various actions we have undertaken on this matter through the Platform, we kindly request your collaboration in the following questionnaire, developed by ASEBIO in collaboration with the Ministry of Agriculture, Fisheries and Food (MAPA) to gather the main concerns of companies in the sector regarding the regulatory change, given the socio-economic impact this has on biotechnology companies in the health, industrial, and agri-food sectors, and how this may affect future developments in these fields.
Your participation in this brief survey is of utmost importance to gather the opinion of the biotechnology business fabric and to convey these concerns to the relevant Spanish authorities that are assessing the impact of the CJEU ruling.
Deadline: January 23, 2019.
* The Directive on GMOs that products resulting from these techniques will face involves very long and costly regulatory processes. The ruling by the CJEU, which considers organisms developed through genome editing to be analogous to GMOs, eliminates the financial incentives for companies to research the process for use in the European Union, in addition to the potential loss of foreign investors or the exodus of such entities to more favorable regulatory environments.



