European Commission study suggests gene editing legal framework needs updating

The European Commission has published a study regarding the status of new genomic techniques under EU law, pointing to a need to reform the current legal framework. The Commission defines new genomic techniques as techniques that are capable of altering the genetic material of an organism and that have emerged since 2001, when the existing EU legislation on genetically-modified organisms (GMOs) was adopted. In 2018, the Court of Justice of the EU (CJEU) ruled that organisms obtained through new genomic techniques are subject to the GMO legislation, a controversial decision ever since. The study does not question the ruling, but argues that ‘developments in biotechnology, combined with a lack of definitions (or clarity as to the meaning) of key terms, are still giving rise to ambiguity in the interpretation of some concepts, potentially leading to regulatory uncertainty’. The document also notes that the current EU legal framework has been reported to have a negative impact on public and private research on new genomic techniques in the EU. It then acknowledges that products obtained from such techniques could contribute to the objectives of the EU’s Green Deal (for instance, by enabling plants more resistant to diseases and environmental conditions and facilitating gaster plant breeding). The study also highlights that the current regulatory system poses implementation and enforcement challenges in the EU, which could lead to trade limitations and disruptions, putting EU operators at a competitive disadvantage. Finally, it recommends that policy instruments are considered ‘to make the legislation more resilient, future-proof and uniformly applied’ and to ensure a balance between reaping benefits from innovation and addressing concerns.

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