In December 2025, the Council of the EU and the EU Parliament reached a provisional agreement on a new set of rules that establish a legal framework for new genomic techniques (NGTs). This agreement will go forward for ratification by the EU Parliament in spring 2026 and will be published in the Official Journal in the course of 2026. However, it will not be applicable until two years later.
The importance of the agreement
This a significant milestone for innovative plant breeding in the EU. The new rules take account of the enormous scientific progress made over the last decade or so, which has seen the development of new genomic techniques such as CRISPR in the production of plants that are more resilient to climate change and require less resources, fertilisers and pesticides to fight pests. The new rules also aim to reduce the administrative burden for innovators in plant breeding.
Appleyard Lees has reported on the background to this agreement and the EU Council’s approved proposal previously (Broccoli, tomatoes, peppers, plant patents, and the European Parliament). According to the EU, there is a need for “an adapted framework for safe NGT plants that reduces burden, enables innovation and enhances the competitiveness and sustainability of the European agri-food system and the bioeconomy” and this agreement is the outcome of a series of amendments and revisions of the original proposal during different EU presidencies.
NGT plants are plants obtained by new genomics techniques such as targeted mutagenesis and cisgenesis, e.g. using gene editing such as CRISPR technology.
The original proposal included several points that proved contentious, one of which was amendment to the Biotech Patent Directive to exclude from patentability all NGT plants as well as plants obtained by random mutagenesis or cell fusion. The exclusion would have extended to plant parts, and plant material thereof, as well as to genetic information and process features found in such plants. During successive EU Presidencies, the proposed text of the proposal was amended multiple times.
The proposal approved in December does not include an outright ban on the patenting of plants or plant material from plants formed using NGTs. NGT plants are classified as Class 1 or Class 2. Patent protection is available for both classes.
NGT-1 plants are equivalent to conventional plants. Plants with more complex or less “natural-equivalent” genomic modifications are classified under category 2. For NGT-2 plants, both the Council and the Parliament agreed with the Commission’s proposal to maintain the existing GMO legislation requirements, including mandatory labelling of products.
What does the proposed agreement cover?
The approved proposal provides measures to increase transparency regarding patents relating to NGT plants and addresses concerns voiced by plant breeders and farmers on patenting, including:
- Public database disclosure: Information on all existing or pending patents relating to the NGT plant must be submitted (and kept up to date) to a public database of Class I NGT plants run by the Commission when applying to register a Class I NGT plant.
- Licensing indication: On a voluntary basis, the plant holder can indicate the patent holder’s willingness to issue licenses for the use of a patented Class I NGT plant or product.
- Expert group formation: The proposal provides for the creation of an expert group on the effect of patents on NGT plants, with experts from member states and the European Patent Office (EPO) and the Community Plant Variety Office (CPVO).
- Study commissioned: The Commission was mandated to publish a study on the impact of patenting on innovation, on the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. The study was proposed to include a special focus on how breeders can access patented NGT plants.
The study mentioned in the agreement will be published one year after entry into force of the regulation. This study will focus on the impact of patenting on innovation, the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. Following the results of the study, the EU Commission will indicate whether follow-up measures are required or publish a legislative proposal to address any issues found in the study.
Related to this larger study, the EU recently published research titled “Supporting innovation in the EU bioeconomy through intellectual property protection”. This research was commissioned as a result of the Commission adopting its original proposal which announced that it would carry out “an assessment of the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding, on breeders’ access to genetic material and techniques and on availability of seeds to farmers” and that the recently published research “is intended as an input into that assessment”. The full study can be found here: Supporting innovation in the EU bioeconomy through intellectual property protection.
This initial study is detailed and aims to “clarify the potential economic and legal impacts of IP protection, including its implications on market concentration, innovation incentives, transparency and overall EU competitiveness”.
The key finding of the report is that that a balanced and coherent IP system is fundamental for innovation in the plant breeding and plant biotechnology sectors. Patents have an important role in rewarding research and attracting private investment to fund R&D intensive companies. The report also finds that Plant Variety Rights (PVRs) safeguard accessibility of plants and plant material and ensure diversity.
Commentary from various seed, agritech, and plant bioscience industry stakeholders has been generally positive and there has been relief that the initially proposed ban on plant patents has been overturned. It is notable that the Germany abstained from voting related to agreement and according to the campaign Save Our Seeds, Belgium, Bulgaria, Croatia, Austria, Romania, Slovenia, Slovakia, and Hungary also opposed the agreement. It will be interesting to see whether plant research and innovation using NGTs will progress across the EU in the years to come.
For further information on how to protect plant related innovation using the patent system or plant variety rights, please contact our plant science experts.
