Gene-editing: a block on further development

In late July, Europe’s highest court handed down a much-awaited ruling on gene-editing which was met by an uproar from parts of the scientific community.

For Huw Jones, professor of translational genomics for plant breeding at Aberystwyth University in Wales, the EU has essentially “turned back the clock on innovation”. This is unlike many other countries that have signalled that, with certain conditions, gene-edited crops are not be regulated by genetically modified organisms (GMO) laws.

After awaiting regulatory clarification for years, researchers and developers were shocked by the court’s decision to subject genome-editing techniques, including CRISPR/Cas9, to more stringent regulations.

On July 25, the Court of Justice of the European Union (CJEU) held that genome-editing falls into the GMO category, meaning it’s covered by the GMO directive.

This means that organisms obtained by mutagenesis, the technique where the genome of a living species is altered without the insertion of foreign DNA, must fulfil the obligations laid down by the GMO directive.

GMOs must be authorised following an assessment of the risks which they present for human health and the environment. They are also subject to traceability, labelling and monitoring obligations—each presenting an onerous task for those looking to develop and sell these techniques.

Confédération paysanne, a French agricultural union, had alleged that herbicide-resistant seed varieties posed a significant risk to the environment and human and animal health, in the same way as GMOs obtained by transgenesis—the process of introducing an exogenous gene into a living organism.

While the CJEU concluded that organisms obtained by mutagenesis are GMOs, it added that older techniques of mutagenesis with a “long safety record” are exempt.

“This decision is both illogical and bad for plant breeding innovation. It encourages older forms of random mutation breeding, which it exempts from GMO regulations, but effectively blocks modern, targeted approaches, which it defines as GMOs and demands disproportional levels of safety data,” says Jones.

Finally, the CJEU noted that EU member states can legislate on such GMOs, provided they do so in a manner that is compliant with EU law.

“The court had to use a limited toolbox (the 2002 directive),” explains Geert Glas, senior IP counsel at Allen & Overy. “Fundamentally, the court had to say ‘we have no specific rules, so we will apply the old rules to a new scientific reality’.”

He says that applying the directive to new techniques of mutagenesis is like comparing apples with pears (the new tools being pears).

Glas adds: “In the end, the CJEU interprets the law but does not make the law. The court however went quite far in limiting the scope of the mutagenesis exemptions.”

What was the industry hoping for?

“The seed sector in Europe had hoped for a clarification that finally acknowledges that these technologies can be applied in different ways, leading to different results that may, and in fact should, be treated differently by the regulator,” says Garlich Von Essen, secretary general at the European Seed Association, a trade organisation representing the seed industry.

While some of these techniques lead to a regulated GMO, others do not, and this differentiation can be made only when we do not solely look at technologies but also consider the final outcome of the process, he explains.

This is the approach most other countries across the globe have taken, says Von Essen, now that they realise that the “rather simplistic approaches of the old GMO rules aren’t fit for purpose for the next era of plant breeding innovation”.

In a further blow to the sector, the judges of the CJEU overturned the opinion of advocate general Michal Bobek, who had proposed “exactly such a more differentiated, more end result-oriented interpretation of the EU legislation”, concludes Von Essen.

Biotech industry group EuropaBio had been hoping for a ruling that would provide the legal certainty and predictability that are essential for the EU’s public and private research into innovations that can address EU and global challenges.

“Instead, this ruling brings genome-editing into the EU’s GMO regulatory framework, which has never been properly or efficiently implemented,” warns Beat Späth, director of agricultural biotechnology at EuropaBio.

Below, LSIPR outlines some of the effects this decision might have.

Expelling innovation

The bottom line is the ruling doesn’t ban gene-edited organisms, but it does make it less straightforward to develop and bring them to market, and introduces significant uncertainty, claims Daniel Rowe, senior associate at Dehns.

These sorts of considerations add costs and risks, he adds, which will put off many investors so the flow of money into research and development in this area will dwindle.

The current GMO framework is characterised by lengthy and sometimes scientifically unjustified assessment procedures, explains Späth. He adds that it even allows for national bans on the cultivation of GM crops for non-scientific reasons.

Späth goes on to say: “The EU has essentially expelled GM crop innovation, and now runs the risk of locking out the benefits of genome-editing from Europe.”