Questionnaire on European Regulations on Gene Editing

On July 25, the Court of Justice of the European Union (CJEU) ruled that organisms obtained by mutagenesis (through genetic editing techniques such as CRISPR, among others) constitute Genetically Modified Organisms (GMO) and would be subject to the obligations established in Directive 2001/18/EC on GMOs.

The ruling may represent a regression* for genomic editing techniques such as CRISPR and therefore, from BIOVEGEN, and within the framework of the different actions that we have undertaken from the Platform in relation to this matter, we ask for your collaboration in the following questionnaire, developed by ASEBIO in collaboration with the Ministry of Agriculture, Fisheries and Food (MAPA) in order to gather the main concerns of companies in the sector regarding the change in regulations, given the socio-economic impact that this entails for biotechnology companies in the region. health, industrial and agri-food sectors, and how this may affect future developments within these fields.

Your participation in this brief survey is of utmost importance to gather the opinion of the biotechnology business community and convey these concerns to the relevant Spanish authorities that are evaluating the impact of the CJEU ruling.

Deadline: January 23, 2019.

* The GMO Directive that products produced from these techniques will face involves very long and expensive regulatory processes. The CJEU ruling that considers organisms developed through genome editing analogous to GMOs eliminates financial incentives for companies to investigate the process for use in the European Union, in addition to the possible loss of foreign investors or exile of this type of entities to more favorable regulatory environments.