An agreement has been reached on a regulation that would allow certain NGT plants, whether or not they are covered by a patent, to be grown in the European Union; expected to be approved by end 2025, the new rules will open previously barred markets to innovative players in the biotech and agritech sector.

European Union (EU) legislation on the use of genetically modified organisms (GMOs) in agriculture is quite restrictive, and has led to several EU member states completely ruling out or heavily limiting the growing of GMO crops in their jurisdictions.

Over the last few years, EU legislators have been working to change the current legislative framework in order to allow a safe and deliberate release, as well as market placement, of plants and their produce obtained through a number of new genomic techniques (NGTs) such as cisgenesis and targeted mutagenesis.

A Proposal for a new “Regulation on plants produced by certain new genomic techniques” was tabled by the European Commission in 2023; if approved, the new regulation would provide an exception to the application of EU legislation on GMOs to NGT-obtained plants (NGT plants) upon condition that the plants can also occur naturally or be produced by conventional breeding techniques.

The above proposal, however, raised concerns about the risks associated with patents and intellectual property rights in general on such plants, with organisations across the EU voicing fears that patent holders for methods and products could act as gatekeepers, potentially restricting market access for farmers and small companies, with a negative ultimate impact on consumers. Discussions on this point led to an amendment of the proposal introducing a total patent ban on allowed NGT-obtained plants; a two-year deadlock ensued, blocking the regulation’s progress.

On 14 March 2025, EU member states finally agreed on a new draft Regulation no longer including a patent ban; the new draft introduces a mechanism that requires parties beginning the verification procedure to either disclose any process or product patents used in developing or producing the NGT plant, or declare the absence of any patents; when patents are disclosed, owners may also declare their willingness to license the patents on a fair and equitable basis.

The final text of the regulation is currently being examined by the EU Parliament; official sources expect the definitive text to be adopted by the end of 2025.

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