(Science|Business) Council adopts regulation on new genomic techniques

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After years of wrangling over sustainability and patenting concerns, the EU Council has formally adopted a European regulation on new genomic techniques (NGTs). It now goes to the European Parliament for a vote, where MEPs unhappy with the outcome of negotiations are expected to mount a last-minute challenge. 

Europe’s problem with NGTs dates back to a 2018 ruling by the Court of Justice of the EU that gene editing techniques should be covered by existing rules for genetically modified organisms (GMOs), which strictly control methods that move genes between different species. Attempts to transition from a total ban on growing gene-edited crops and putting derived products onto the market towards a more relaxed regulatory framework began in 2023, when the European Commission proposed easing the rules to harness the benefits of gene editing for competitiveness and food security. 

Deemed more predictable than older transgenic techniques, NGTs are used to design or enhance traits of interest in plant species to improve their nutritional profile or increase their resistance to disease and harsh climatic conditions.

Negotiations between the Council, Parliament and Commission on the final form of the regulation were concluded under the Danish presidency in December, before Cyprus took over the file in January.

As agreed last year, NGTs will be split into two categories. In Category 1, NGT plants are considered equivalent to conventionally bred varieties and exempt from the GMO legislation. They will not be labelled, except for seeds and other reproductive material, and their offspring will not require further checks. 

Following pressure from MEPs, NGT plants which present certain intended traits, such as herbicide tolerance and the production of known insecticidal substances, will be excluded from Category 1 and classed as NGT-2. In Category 2, NGT plants have more complex modifications and must stick to GMO rules. They will therefore be subject to authorisation, traceability and labelling requirements.

Objections remain

But some MEPs are still unhappy with the outcome. Christophe Clergeau, a member of the Socialists and Democrats group who sits on the Parliament’s environment committee, thinks the compromise text is “flawed,” with many issues still unresolved, especially with regards to patenting. 

“This text represents a form of privatisation of life. NGTs allow us to reproduce what nature already does,” he wrote on social media. “Tomorrow, these traits could be patented like industrial inventions. We are establishing a real toll on genetic resources. Farmers will have to pay more for their seeds than they do today, and small and medium-sized seed companies will be subject to the arbitrary power of large patent holders, which will wield considerable influence over them.”

Before the trialogue agreement was reached, the Parliament had asked for a full ban on patents to avoid giving multinational seed companies a monopoly and depriving farmers and small breeders of access to NGTs. However, this position did not survive the negotiations.

On April 8, a dozen MEPs wrote to Stéphane Séjourné, the commissioner responsible for industrial strategy, raising concerns over the lack of clarity on patenting genetic traits that may also occur naturally or be achieved via conventional breeding. “The focus has shifted to transparency measures, an expert group and a future assessment by the Commission,” they wrote. “While these elements are valuable, they do not replace a clear political and legal solution.”

Protesting MEPs will need an absolute majority to challenge the regulation in the plenary session, which is set to take place between May 18 and 21.

Patent protections

Under the new transparency measures, NGT-1 plant developers must submit patent information to a public database and can voluntarily indicate licensing intentions. The Commission is also expected to draw up a code of conduct on patents in this area, and set up an expert group on the effect of patent law and the implementation practice on access to modified genetic resources, transparency of the patent landscape and innovation in the field of NGT plants.

The European Patent Office (EPO) will be part of this group. Its spokesperson, Roberta Romano-Götsch, sought to calm concerns. “Patents, in themselves, do not confer market dominance,” she told Science|Business. “Patent protection is available equally to small and large innovators, and figures show that around one third of European patent applications relating to genetically-modified plants originate from SMEs.”

She also recalled that breeders already had access to online databases to support their selection of breeding material, including the EPO’s Espacenet, which contains over 150 million patent documents from around the world. In addition, the organisation offers guidance on patentability requirements and training resources. She finally cited private initiatives, such as the European Seed Association’s Pinto database, which links plant varieties and patents.

“Predictable and stable intellectual property frameworks are widely recognised as an important factor for innovation,” Romano-Götsch added. “Restrictions on patenting plant-related inventions, particularly genome editing, could weaken incentives to innovate and reduce transparency through greater reliance on trade secrets.”

As mentioned in the compromise text, the EPO requires a disclaimer to make sure that the patents on plants made by technical methods do not extend to plants produced by “essentially biological processes.”

Claire Skentelbery, director general of industry body EuropaBio, shared her support for the text. “It’s a political compromise but still represents a significant step forward for the EU,” she said. “Such biotech platforms are very accessible, so we expect to see smaller innovators really burst into life.”

As previously agreed, individual EU states will be allowed to opt out from the cultivation of NGT-2 plants on their territory.

NGT-2 plants will also be banned from organic production. Meanwhile, the compatibility of the use of NGTs with the principles of organic production requires further consideration, the text says. “The use of category 1 NGT plants should therefore be prohibited in organic production until such further consideration takes place.”

The Council anticipates the new framework will apply from mid-2028.