Gene editing might not be covered by EU legislation in the future
Hundreds of millions of dollars has been invested in gene editing technology. There have been calls for techniques like CRISPR-Cas9 that are used to remove specific parts of genetic codes to be regulated by EU legislation; however, according to the advocate general from the European Court of Justice, this might not go ahead.
The courts are currently in the process of deciding whether gene editing should be regulated under GM regulation. If this were to go ahead, it would mean crops and drugs that are modified using these methods would be subject to labeling, authorization and safety checks. The advocate general, Michael Bobek, has expressed the opinion that it should be exempt from the laws – an opinion that’s been welcomed by scientists, although they’ve admitted it should be approached with caution.
One group that have welcomed the news is EuropaBio, who represent some of the most influencial biotech industry groups in the EU. John Brennan, EuropaBio’s secretary-general said: “The advocate general’s opinion demonstrates that necessary steps are being taken towards clarifying the regulatory status of products that have been developed using the latest biotechnological tools and applications. We trust that the forthcoming ruling will contribute to establishing regulatory clarity.”
It’s Michael Bobek opinion that “organisms obtained by mutagenesis” should not be treated as genetically modified unless they contain recombinant nucleic acid molecules or other GM organisms. Critics have argued that all genetic mutations that are carried out in labs are automatically artificial and should be treated as such, although industries have argued that these alterations could occur naturally through evolution.
Dr Michael Antoniou, the head of the molecular genetics department at King’s College London, argued that making these technologies exempt from regulations is “wrong and potentially dangerous”. He added: “None of these gene editing methods are perfect. They have ‘off target’ effects that can inadvertently disturb the biochemistry of organisms leading to unintended outcomes which – if you’re making a new gene edited food crop, for example – could result in the unexpected production of a new toxin or allergenic substance.
Beat Späth, director of agricultural biotechnology at Europabio, a lobby organization for the bioindustry in Brussels commented that “We still need to understand some of the technical issues involved in different applications of gene editing to see how broadly the existing legal exemption might apply.” Friends of the Earth have also agreed that the EU needs “to not uphold today’s opinion, and instead make sure that all new genetically modified foods and crops are properly regulated.”
Michael Bobek has noted, however, that individual states can choose to regulate gene editing if they choose to despite the legislation. He said that there would be nothing to stop EU countries creating their own rules for the use of technologies. Critics have urged that laws should be consistent, and using different rules across member states would undermine the single market.
