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30 July 2018Biotechnology

CJEU gene-editing decision ‘could stifle’ innovation in Europe

A ruling handed down last week by the Court of Justice of the European Union (CJEU) could stifle innovation in the gene-editing field, causing Europe to lag behind the rest of the world, commentators say.

The judgment has cemented the EU’s negative stance on genetically modified (GM) crops, according to Simon Kremer, partner at Mewburn Ellis.

“While progress in that field is still incentivised by the patent system, the regulatory environment continues to make it a less attractive area for research in Europe, which thus lags behind the world in this area,” he added.

On Wednesday, July 25, the CJEU held that genome-editing techniques fall into the GM organisms (GMO) category and are therefore covered by the GMO directive.

According to the court, organisms obtained by mutagenesis (which alters the genome of a living species without the insertion of foreign DNA) meet the GMO definition.

GMOs must be authorised following an assessment of the risks which they present for human health and the environment.

While it was hoped that the ruling would deliver legal certainty and predictability, the decision has failed to provide the necessary regulatory clarity needed by EU researchers, academics and innovators, said EuropaBio’s secretary general John Brennan.

EuropaBio, a biotech industry group, warned that in the absence of improved legal clarity, Europe could miss out on significant benefits of certain applications of genome-editing.

Kremer added that although followers of EU jurisprudence and decision-making will perhaps not be surprised by the ruling, innovators who had hoped to avoid the obligations of the GMO directive by using precision mutations in crops will be “deeply frustrated”.

Despite its findings on mutagenesis, the CJEU added that older techniques that have a “long safety record” are exempt from the GMO directive.

Penny Gilbert, partner at Powell Gilbert, believes this will create a situation where older, random methods of mutagenesis are likely to be more cost effective.

This will reduce the incentive for development of new and improved crops by DNA-editing and will impact further innovation of the techniques themselves for use in agriculture, she said.

Sarah Schmidt, project coordinator at the institute for molecular physiology, University of Düsseldorf, claimed that the decision is the “deathblow for plant biotech in Europe”.

Speaking to Science Media Centre, which collects expert reactions to industry news, she explained that only the largest agribusinesses can afford the costs of obtaining approval for GMO crops.

With the CJEU’s ruling, universities, start-ups and not-for-profits that might produce innovative solutions to tackle world hunger and crop adaption to climate change are excluded from the breeding process, she argued. “So, Europe leaves it to big biotech companies to address the biggest humanitarian challenges of our time: hunger and climate change.”

Denis Murphy, professor of biotechnology at the University of South Wales, also submitted comments to Science Media Centre.

He warned that while the rest of the world will use genome-editing for human welfare, sadly, Europe might miss out on such opportunities.

“By simply lumping together genome-editing with the completely different GM/transgenic biotechnologies, the CJEU has missed a historic opportunity to create a new regulatory framework for this new biotechnology,” added Murphy.

For more background on the court’s decision, read our reporting here.

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