European Parliament looks set to ban patents for all NGT plants

The European Parliament has confirmed its position on a proposal pertaining to plants produced by new genomic techniques (NGT). Among the revisions is a move to ban all patents on all NGT plants; a plenary session taking place next week could see the waiver go through.

The European Parliament’s Committee on Environment, Public Health and Food Safety has adopted an amended version of a European Commission’s proposal, to ban the imposing of patents and limit the effects of existing patents, on all NGT plants. It voted 47 to 31 in favour with four abstentions. Members of the European Parliament (MEPs) comprise the committee, which also supports adopting a looser approach to categorising NGT plants.

Council negotiations upcoming

Parliament could adopt the changes as soon as 5-8 February 2024, which is its next plenary session. However, the European Council must also approve the proposal before parliament can take it to the EU member states.

While the regulation, published in 2023, barely mentions IP rights, the proposed amendments cover “NGT plants, plant material, parts thereof, genetic information and process features they contain, to avoid legal uncertainties, increased costs and new dependencies for farmers and breeders”.

In a press release, Jessica Polfjärd, MEP and member of the Moderate Party in Sweden, says, “This proposal is critical for strengthening Europe’s food safety in a sustainable manner. We finally have a chance to implement rules that embrace innovation and I look forward to concluding negotiations in the parliament and with the council as soon as possible.”

NGT plants for the future

According to the European Parliament, banning patents for NGT plants aims to make Europe’s food system more sustainable and resilient by, for example, wider accessibility to crops which require fewer fertilisers. It also cites concerns over climate change and developing pest-resistant crops as further impetus to relax regulations around NGT plants.

By June 2025, the commission should also present a report to the European Parliament, the European Council, the European Economic and Social Committee, and the Committee of the Regions. This should pertain to “the role and impact of patents on breeders’ and farmers’ access to varied plant reproductive material… on innovation and… opportunities for SMEs”.

The proposal also suggests amendments to the Biotech Directive (98/44/EC), which would ban patent rights for all plants obtained by classical mutagenesis or cell fusion. New genomic techniques are ways of altering the genetic material of an organism, such as with CRISPR/Cas, in order to allow rapid development imbued with specific desirable characteristics.

Biotechnology changes

Generally, in Europe’s patent offices, inventions relating to biological material are eligible for patent protection. With regard to the current proposals, observers are concerned that a ban on patenting NGT plants could disincentivise product development, bringing a loss of innovation and lack of investment into NGT products in the EU.

However, those in favour speculate that it will reconcile the interests of agricultural stakeholders in Europe. For example, the commission suggests that the changes will give farmers and breeders greater access to the required technology, with fewer economic barriers.

In summary, the commission lays out its proposal aims as: maintaining a high level of protection of human, animal, and environmental health; enabling the development and marketing of plants and plant products contributing to the innovation and sustainability objectives of the European Green Deal and of the Farm to Fork and Biodiversity strategies; ensuring the effective functioning of the internal market in NGT plants and products and food and feed; enhancing the competitiveness of the union agri-food sector, including a level-playing field for operators.

Plants in two categories

Also proposed by the commission is the introduction of two categories of NGT plants. NGT 1 plants, which are considered equivalent to conventional plants, would be exempt from GMO legislation requirements. MEPs proposed rules on the size and number of modifications needed for an NGT 1 plant to be considered a conventional plant equivalent, as well as suggesting clearer labelling for NGT seeds. They also proposed publishing an online public list for all plants in the NGT 1 category.

For NGT 2 plants, MEPs agreed to maintain existing GMO legislation and agreed to an accelerated risk-assessment procedure.

According to the proposal, a study delivered by the European Commission in 2021 concluded that the EU’s current GMO legislation is not fit to cover regular NGT plants as obtained by targeted mutagensis or cisgenesis. These two techniques bring higher precision and speed in introducing desired genetic modifications. They concern the insertion of genetic material from a crossable, rather than non-crossable, species.