Court ruling could lock out the benefits of genome editing from Europe

Responding to today’s Court of Justice of the EU ruling on organisms obtained by mutagenesis (Case  C-528/16), EuropaBio’s Secretary General John Brennan highlighted industry’s concerns about the judgement. He warned that in the absence of improved legal clarity in this area, Europe could miss out on significant benefits of certain applications of genome editing.

“In addition to providing consumer and environmental benefits, such as enhanced nutrition, improved health or a more circular economy, innovations made possible by genome editing hold enormous promise to keep Europe at the forefront of socio-economic development, continuing to generate jobs and growth in the EU,” he said.   “Unfortunately, this court ruling, which is inconsistent with the Advocate General’s Opinion published in January, does not provide the necessary regulatory clarity needed by EU researchers, academics and innovators.”

Following more than ten years of discussion, it was hoped that this ruling would provide the legal certainty and predictability needed by EU public and private researchers to deliver solutions to the UN’s Sustainable Development Goals.

Commenting further, Brennan noted: “Public confidence and science-based decision-making are both important for ensuring that genome editing can deliver needed solutions. Looking forward, EuropaBio believes that the next step, for the EU and its Member States, is to engage citizens in an inclusive and fact-based dialogue on what genome editing is, and what it will or will not be used for. It will be important to build knowledge, develop understanding and deliver risk-proportionate policy approaches, allowing innovation, which is already taking place in other parts of the world, to also benefit the EU’s society, economy and the environment.”

Additional information:

• The matter was referred to the CJEU by the French Conseil d’Etat after nine NGOs initiated a court case in France related to mutagenesis and the most recently developed mutagenesis methods. Such methods, which include certain applications of genome editing, help to develop innovative and sustainable solutions similar to those realised through conventional techniques, but with even greater accuracy and efficiency.
• Specifically, the court ruling was intended to clarify the scope of the mutagenesis exemption in the GMO Directive, which is essential for providing legal certainty and predictability.
• Genome editing is currently being applied in a broad range of projects, including:  
  • The development of crops to improve yields and reduce food waste;
  • The design of therapeutic tools for recognising specific viral DNA and eradicating HIV proviruses;
  • The production of bio-based chemicals to help provide renewable substitutes for many traditional petrochemical building blocks.
• Further potential fields of application include nutrient-enriched and stress-resilient crops that can help tackle malnutrition and cope with effects of climate change; the development and production of medical treatments and diagnostic agents that can improve and save millions of lives.

Further references:

• The Court of Justice of the EU Ruling on Case  C-528/16 and associated Press Release
• EuropaBio’s position paper “Achieving the potential of genome editing - the perspective of the European Biotech Industry”
• The European Commission’s Scientific Advisory Mechanism (SAM) published an explanatory note on New Techniques in Agricultural Biotechnology. It confirms that “the precision and control over changes made is greater than with the use of conventional breeding or established techniques of genetic modification. As a consequence, these new techniques result in fewer unintended effects”.
• The European Seed Association’s position paper “Plant Breeding Innovation: Applying the latest Plant Breeding Methods for the benefit of sustainable Agriculture, Consumers and Society”