Rapid advances in genetic engineering, such as the development of the CRISPR-Cas9 gene-editing tool, have enabled the development of so-called ‘gene drives’. These are genetically modified organisms that are designed to spread a genetic modification through entire natural populations of sexually-reproducing plant or animal species, in order to alter or eradicate these populations. In June 2016, the US National Academies of Sciences concluded that ‘there is insufficient evidence available at this time to support the release of gene-drive modified organisms’. The matter of gene drives is being investigated by an expert group of the Convention on Biological Diversity (CBD) and is likely to be discussed at the upcoming conference of parties in Cancun, Mexico.
1. In view of the precautionary principle, does the Commission consider that the level of scientific knowledge regarding the functioning of CRISPR-based gene drives and the current risk assessment methodologies are adequate to assess the biosafety implications of a field release or accidental laboratory escape of such organisms?
2. What measures is the Commission planning within the Cartagena Protocol to prevent spontaneous, non-authorised transboundary movements of gene-drive modified organisms?
The Commission is in the process of consulting the Commission’s Scientific Advice Mechanism (SAM) to provide an explanatory note on new techniques in agricultural biotechnology, including genome editing technologies (such as CRISPR/Cas), as well as possible uses of new techniques such as gene drive systems.
The aim is to improve the scientific understanding of these techniques taking into account the extensive variation in their possible applications and the way they are used. The SAM has been recently set up to support the Commission with high quality, timely and independent scientific advice for its policy-making activities and draws on the wide range of scientific expertise in Europe through a close relationship with national academies and other bodies, as well as the expertise of a High-Level Group of independent scientific advisors.
The current scientific understanding seems to indicate that organisms modified through gene drive mechanisms fall under the EU Genetically Modified Organisms legislation and the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. On this basis, they are subject to all relevant provisions, including those set under Regulation (EC) No 1946/2003(1) on trans-boundary movements of genetically modified organisms.
(1) OJ L 287, 5.11.2003, p. 1.