Advancing Sustainable Agriculture: A New Regulatory Landscape in the European Union

In the rapidly evolving landscape of agriculture, February 7, 2024, marked a pivotal moment within the European Parliament. Amidst discussions on new and sustainable farming practices, Members embraced a proposal addressing the regulation of plants derived from new genomic techniques (NGT plants).

This proposal signifies not just a legal decision but a crucial step toward transitioning to more resilient and sustainable agriculture in the European Union. From easing regulatory constraints to safeguarding farmers’ rights, the implications of this decision resonate far beyond the walls of the Parliament chambers.

The Significance of New Genomic Techniques

Within New Genomic Techniques (NGTs)—a category encompassing novel methodologies introduced within the past two decades (post-2001)— there are new methods empowering researchers to target and alter specific regions of a plant’s DNA, steering clear of random mutations (targeted mutagenesis). Additionally, NGTs enable the insertion of genetic material from related plants capable of crossbreeding in nature (cisgenesis).

According to the European Green Deal, “these new techniques can help develop climate-resilient crops, ensuring more sustainable, high-quality and diverse seeds and reproductive material for plants and forests.”

Updating Categories of New Genomic Techniques

The final revised proposal presents a more lenient framework: Plants obtained through NGTs can earn equivalence status to conventional plants (category 1 NGT plants) by adhering to specific criteria. Notably, the initial proposal constrained the number of specific genetic changes to a maximum of 20 nucleotides per DNA sequence.

The revised version, however, alters the parameters governing this category, potentially resulting in more stringent criteria that could reduce the number of plants meeting the requisites for category 1 NGT plants compared to the original proposal.

Safeguarding Farmers and Plant Breeders

Farmers’ groups and agri-cooperatives in the EU have shared their thoughts on the proposal, welcoming the science-based decision and highlighting the importance of understanding the impact of patents on plant breeder’s rights. To address these concerns, members of the European Parliament called for a complete ban on patents for all NGT plants and related genetic information and processes.

An amendment to the original Commission’s proposal added that “allowing for NGTs and their results to be patented risks giving multinational seed companies even more power over farmers’ access to seeds. In a context where large companies already have a monopoly on seeds and increasingly control natural resources, this would deprive farmers of all freedom of action by making them dependent on private companies. For this reason, patents on these products must be banned.”

The European Parliament has urged the Union and its Member States to refrain from granting biological material patents and uphold breeders’ rights. They propose exempting NGT plants from patent laws and protecting them solely under the Community Plant Variety Rights system. This means that NGT plants, their seeds, and genetic material should not be patentable.

Assessing patent impacts

The amendment also calls on the Commission to report by June 2025 on how patents affect breeders’ and farmers’ access to different plant materials and how they impact innovation, especially for small businesses. The report will also determine if additional legal rules are needed beyond what’s already in the regulation.

If necessary to ensure breeders and farmers can access plant materials, diversify seeds, and keep prices affordable, the report will include proposals to change intellectual property laws.

The role of intellectual property

Faced with the new regulation, stakeholders and innovators are concerned that intellectual property (IP) provisions amended on the proposal could significantly impact the patentability of plants, genetic material, and processes in the European Union.

The International Association for the Protection of Intellectual Property (AIPPI) found the proposed plant patent ban too broad and vague. “The proposed ban on plant patents threatens innovation in Europe’s critical plant industry and could harm Europe’s competitiveness in the long run. This undermines the original aim of promoting research and innovation in NGT plants,” said AIPPI’s Standing Committees on Biotechnology and Plant Varieties and Patents.

IP law experts from the De Clercq & Partners team have also shared their views on this perceived loss for the Agriculture and Biotechnology industries: “While the original proposal … was intended to support the green transition of the agrifood sector and support innovation in Europe—as well as to entail more investments in agricultural biotechnology from the public sector, SMEs, and plant breeders to offer a wider variety of crops to farmers and citizens—the weakening of the patent protection for these products will inevitably lead to less rather than more EU-based innovation.”

Moving Forward while Aiming for Balance

We see this as a significant progress of the European regulatory authorities’ point of view and a great deal of breakthroughs as it reflects the change in mindset, which is the first step in recognizing the importance of advanced genome technologies to support the human society dynamics.

Eyal Ronen, EVP BD of Evogene

The European Parliament’s stance underscores the need to protect breeders’ rights and encourage innovation while preventing monopolistic control over agricultural resources. There’s also an emphasis on assessing the potential impacts of the intellectual property aspects of the proposal, not only on the competitiveness of the European Agbiotech industry but also on innovation in plant traits overall.

The revised proposal is now moving forward for more discussion with member states and the European Commission in the Council of the European Union. As the EU aims to regulate modern sustainable agriculture, there’s a widespread call for striking a balance between promoting innovation and preserving farmers’ agency.