Crops and drugs created using powerful gene-editing techniques such as CRISPR–Cas9 might not need to be regulated by the strict European Union rules that govern genetically modified organisms (GMOs), according to a formal opinion from an advocate general in the European Court of Justice.
European scientists have cautiously welcomed the carefully worded document, published on 18 January. They would like to use precise gene editing, which allows tiny changes to be made to a genome in a simple and highly controlled manner, to create hardier plant species or to improve medical treatments. But legal uncertainty about existing rules has hindered progress in Europe, say researchers.
The 2001 EU directive that governs the deliberate release of GMOs into the environment was drafted long before such methods were developed. A bitter dispute over whether the directive applies to the newer methods has, in effect, led to a moratorium on any use outside the lab.
“We have a feeling that this opinion goes in a clarifying direction,” says Ralf Wilhelm at the Julius Kühn Institute, the German federal research centre for cultivated plants, in Quedlinburg. “At least the opinion doesn’t say that all products created with the new gene-editing techniques should automatically be considered under all the obligations of the GMO regulations.”
The European Court of Justice is the highest court within the European Union. It usually follows closely the advice of its advocates general, and is due to rule on the matter this year.
The stakes are high, because if gene-edited products are deemed to be subject to the directive, the required checks and controls would make it too expensive for European academics and small companies to develop such products for the market, say scientists and entrepreneurs. What’s more, they fear that if gene-edited products were to be considered GMOs, the public would reject them, as happened with genetically modified food. One reason that scientists need to exploit gene-editing techniques, says Wilhelm, is that globalisation and climate change are bringing new diseases to Europe. Being able to adapt crops efficiently would help to avert any disastrous consequences, he says.
The legal confusion arose because the 2001 directive applies to organisms into which whole genes or other stretches of nucleotides have been transferred. However, it exempts organisms whose genomes have been altered by plant and animal breeders using mutagenesis techniques that were available at the time, such as irradiation. Breeders argue that gene editing is a type of mutagenesis because it involves changes to single nucleotides. But opponents say that any changes deliberately made to a gene give rise to genetically engineered products that must be regulated in the same way as other GMOs.
Some 15 months ago, the French government asked the European Court of Justice for an interpretation of the directive. The formal opinion written by advocate general Michal Bobek is complex, and stakeholders are still trying to work out what it might mean in practice.
“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,” says Beat Späth, director of agricultural biotechnology at Europabio, a lobby organization for the bioindustry in Brussels.
Bobek’s text says that there is nothing in the directive to stop member states from making their own rules for gene editing, raising the possibility of a patchwork of different rules applying in different member states, which critics say undermines the single market.