On 7 February 2024, the EU Parliament approved the EU Commission's proposals for new rules on plants obtained through 'New Genomic Techniques' (NGTs) – albeit with a significant amendment to ban patent protection for these plants.
The approved proposal will create two categories of NGT plant, each with their own regulations.
Category 1 NGT plants (NGT-1) are considered equivalent to “conventional” plants and will be subject to fewer regulations, while Category 2 NGT plants (NGT-2) must comply with current Genetically Modified Organism (GMO) legislation.
Crucially, the European Parliament have agreed to modify the proposal to also introduce a full ban on patents for both NGT-1 and NGT-2 plants, as well as plant material, parts thereof, genetic information and process features. They justified this amendment citing concerns over legal ambiguities, heightened expenses, and the potential creation of new dependencies for farmers and breeders. The Parliament has additionally called for a report by June 2025, assessing the effects of patents on breeders' and farmers' access to diverse plant seeds. This ban does not align with the European Patent Convention, nor the EPO’s case law.
What led to the proposal?
The proposal aims to modernize EU legislation on GMOs and clarify the regulatory framework for NGT plants.
NGT plants are obtained using technologies developed post-2001 which can precisely edit or modify genes within an organism's own genome without necessarily introducing foreign DNA; for example, by using targeted mutagenesis, or gene editing techniques like CRISPR. These NGTs offer greater precision and control over genetic changes, potentially leading to more targeted and predictable outcomes.
Under current EU legislation, all plants derived from NGTs face stringent regulations akin to traditional GMOs. Compliance involves navigating complex approval processes and adhering to burdensome traceability and labelling requirements.
There have been calls for a review on this since 2018, when the legal status of NGT-modified plants was first addressed by the European Court of Justice. Further in 2021, the European Commission found the GMO Directive to be unfit for purpose for plants obtained by NGTs, sparking a legislative initiative. The scientific community has widely advocated for the EU Parliament to embrace NGT plants. An open letter signed by 37 Nobel laureates called on the Members of European Parliament (MEPs) to “reject the darkness of anti-science fearmongering”, advising on the “immense promise for sustainable agriculture, enhanced food security and innovative medical solutions” offered by NGT plants.
The Proposal
With 307 votes to 263 and 41 abstentions, MEPs agreed to establish two categories of NGT plants, each with corresponding regulations.
Category 1 NGT plants will be considered to be equivalent to ‘conventional’ plants and will be exempt from the requirements of the strict GMO legislation. However, they will be subject to mandatory labelling for seeds, and must be listed on a public online database. Category 1 NGT plants must differ by no more than 20 genetic modifications from the parent plant in order to benefit from exemption. The amended proposal notes that such plants “could also occur naturally or be produced by conventional breeding techniques”.
Category 2 NGT (NGT-2) plants are defined by default to include all other varieties obtained through new genomic techniques. MEPs agreed to maintain GMO legislation for NGT-2 plants, including mandatory labelling on all parts and traceability requirements. However, to promote their uptake, NGT-2 plants will be subject to an accelerated procedure for risk assessment.
Crucially, the MEPs have agreed to introduce a full ban on patents for both NGT-1 and NGT-2 plants, and also plant material, parts thereof, genetic information and process features. They justified this amendment citing concerns over legal ambiguities, heightened expenses, and the potential creation of new dependencies for farmers and breeders. The Parliament has additionally called for a report by June 2025, assessing the effects of patents on breeders' and farmers' access to diverse plant seeds. This report will be accompanied by a legislative proposal aimed at updating EU regulations in this area.
Both NGT-1 and NGT-2 plants will be excluded from organic production.
Reactions
The proposal has sparked mixed reactions.
Many institutes and companies are enthusiastic about the proposal, applauding the increased freedoms afforded to Category 1 NGT plants, and their potential contributions to the Farm-to-Fork and Biodiversity Strategies under the EU Green Deal. For example, the EPSO and Euroseeds have provided positive feedback on the proposal. However, the deregulation of some NGT plants has not been welcomed by all; the chorus of criticism includes IFOAM Organics Europe, Pesticide Action Network Europe and Safe Food Advocacy Europe (SAFE).
Intellectual Property professionals are yet to weigh in on this issue, potentially awaiting further developments or deliberations before expressing their stance.
On the proposed patent ban, our view is that the MEPs have failed to comprehend the full extent of consequences that could arise from implementing such a ban. We believe that the ban could lead to any or all of:
- A reduction in investment;
- A consequential stagnation in innovation;
- Negative impact on agricultural economies by limiting farmers' access to cutting-edge technologies and reduce their ability to compete in global markets;
- Decreased agricultural productivity and impacted food security, flowing from reduced research into NGT-plants with desirable traits; and
- Increased pesticide and herbicide usage, resulting from fewer options of NGT plants engineered to be resistant to pests or tolerant to herbicides.
Importantly, the proposal conflicts with the European Patent Convention and established case law of the European Patent Office (EPO). Therefore, even if the proposal does become law, it remains uncertain how the EPO, as a non-EU entity, will amend its protocol in view of the proposal. As set out in the EPO’s decision of G3/19 (“Pepper”), plants obtained exclusively through an 'essentially biological process', i.e., processes based on sexual crossing and selection, are excluded from patentability. Conversely, plants produced solely by technical processes which modify the plant's genetic characteristics - including NGTs - remain patentable in Europe, as outlined in the EPO Guidelines for Examination (Part G II (5.4) EPO).
There is also the potential for divergence between the UK and the EU on this issue, with the UK traditionally having been more liberal in their approach, and recently passing the Genetic Technology (Precision Breeding) Act (2023) simplifying requirements for trials of gene edited organisms in the UK. It would seem unlikely that the UK government would wish to follow the EU parliament in altering patent law.
Therefore, in the coming months we will be keeping a vigilant watch on the progression of the proposal through the EU legal system and also on the EPO’s position. We will be sure to keep you appraised of the key developments.
