MEPs have approved plans to loosen regulations around crop plants that are improved using gene editing, but a move to ban patenting of plants that are modified using these techniques could stand in the way of a final agreement
Genetically manipulated crop plants have long been a divisive issue, but the European Parliament’s food safety committee ENVI has now managed to unite industry and environmentalists in opposition to its proposal to ban patenting of plants that are modified using new genomic techniques (NGTs).
MEPs voted through an amendment to the Commission’s proposal to update EU rules to reflect the greater precision of new gene editing techniques such as CRISPR on 24 January.
NGTs are tools used to modify an organism’s genetic make-up without inserting foreign genetic material, or by inserting genetic material from organisms that can cross in nature. These are being used to develop plant varieties with improved properties, such as drought resistance or salt tolerance, or which require fewer pesticides and fertilisers.
Breeders and farmers fear that patents will extend not just to the processes used to obtain certain traits, but to the traits and the plants themselves. NGTs may speed things up, but these traits could also be introduced via conventional breeding methods.
If traceability and labelling requirements are removed for NGT-modified plants, breeders and farmers are worried they will be forced to sign licencing agreements with large companies to use seeds that naturally contain the genetic trait in question, or which are the result of conventional breeding.
The MEPs’ move to ban patenting is a “fake solution”, because revising the EU directive on biotech patents would take several years, says Eric Gall, deputy director of the lobby group IFOAM Organics Europe. The European Patent Convention would also need to be amended, he added.
Rather than banning patents on NGT-modified plants, there should be a legal modification to “make it clear that in no case should genetic material and traits that can be obtained by conventional breeding, or in nature, be subject to a patent,” Gall said. “Patents which are more and more applied to conventional seeds are a threat to the European model of innovation in breeding.”
IFOAM is calling for the plenary vote on the Parliament’s position, currently scheduled for early February, to be delayed so that these concerns can be addressed.
Consensus across industry
The proposed ban on patents requires “a lot more differentiation”, between patents on technology and on traits and plants obtained with that technology, said Garlich von Essen, secretary general of seed industry association Euroseeds.
He said there is “a consensus across a vast majority of the industry” that small companies should continue being able to use the varieties of their competitors, but that firms which develop technologies and traits for companies to use in their breeding programmes do require intellectual property (IP) protection.
Von Essen agrees that an amendment to the NGT regulation is not the right arena in which to strike this balance. “It will not be done with two or three trilogue meetings,” he said.
Instead, the EU should push ahead with the NGT file, and shelve the patenting issue until the Commission publishes its report assessing the impact of patents on breeders’ access to genetic material and techniques, the availability of seeds to farmers, and the competitiveness of European biotech. This is due for 2026, but MEPs want it brought forward to 2025.
“Any company that wants a product on the market will need to put it through the regular variety registering system, which takes three or four years. We can use that time to sort out the IP issue,” von Essen said.
“Patents are an important incentive to drive innovation and related investments,” but they are not the only incentive, said Gabino Sanchez, business development director at Netherlands-based gene editing company Hudson River Biotechnology.
Using traditional methods, it usually takes 12 years to bring a new crop variety to market, making patents essential to safeguard the investment in R&D investments. But gene editing techniques can reduce that to three years.
Discussions will need to take place with stakeholders around patents and other ways to capture value. Those talks should begin now, Sanchez argues, so that once the Commission’s report is published, a new regulatory framework can follow.
Worries that big companies will increase their dominance through patents have “nothing to do with gene editing”, but these techniques exacerbate those fears, as they allow more varieties to be brought to the market much more quickly.
While awaiting that longer-term fix, Sanchez does not expect the proposed patenting ban to hinder innovation, as the R&D process takes several years. The real barrier to innovation would be failing to update the NGT regulation, he said.
Companies is related sectors will be keeping a close eye on the file. EuropaBio, trade association that represents health and industrial biotech companies, worries that decisions here will set a precedent for other sectors, even though agriculture covers just a small percentage of biotech patents. NGTs are used not just in plants, but also in microorganisms, and the first gene edited drug was approved recently.
“Any discussion should be done within the context of the Biopatent Directive. It should be holistic, and not only focus on one sector,” said Anne-Gaëlle Collot, industrial biotechnology director at EuropaBio, Any changes should come after the Commission has published its report.
“For us, bio patents are crucial.” They safeguard investment in research from large firms, and support access to finance for smaller companies, she said.
French microbiologist Emmanuelle Charpentier, co-inventor of CRISPR technology, won the Nobel prize in 2020, but gene edited crops are yet to be introduced in the EU, and policymakers fear the bloc will fall even further behind if the rules are not adapted.
In 2018, the Court of Justice of the EU ruled that NGTs must be subject to the same strict rules as all genetically modified organisms. Yet NGTs did not exist in 2001 when the EU legislation on GMOs was adopted.
The new legislative proposal separates NGT plants into two categories. Category 1, considered to be equivalent to conventionally-bred plants and having undergone fewer than 20 modifications, will be exempted from the requirements in the GMO legislation, unlike Category 2 plants which are more heavily modified.
Industry welcomed the move, although environmental organisations such as Greenpeace have warned that weakening rules on safety checks and labelling requirements would infringe on the rights of farmers and consumers.
MEPs agreed that all NGT-modified plants should remain prohibited in organic production, as this will require further consideration.
The Parliament and Council may yet reach a final agreement on the text before this summer’s EU elections, but the issue of patents could be a stumbling block.
The Council is yet to agree on its position. “We have a majority in Council, just not a qualified majority,” said von Essen. Intellectual property rights are one of the issues currently dividing member states.