On 7 January 2025, the Polish EU presidency published a new compromise proposal on the deregulation of plants genetically engineered through gene-editing techniques like CRISPR/Cas (“NGTs”). The goal is to break the deadlock in the Council on the Commission’s proposal, which dates from June 2023.
The new proposal mainly seeks to find a compromise on patents. However, the Polish presidency wants to avoid a change in patent law, which would be absolutely necessary to restrict the ongoing concentration process in the seed market.
Instead, Poland suggests companies shall not file patents if they want their plants to enjoy NGT1 status. Alternatively, patented seeds of NGT1 plants still may be placed on the market if they are labelled (“patent protected” or “patent pending”). Member States may then take “opt-out” measures to restrict or prohibit the use of patented NGT1 seeds for cultivation (but not the marketing of food and feed products).
The proposal seems to be in conflict with basic principles of non-discrimination: Poland does not seem to be aware that patents are also being granted on plants derived from random mutagenesis processes. Those plants still could be circulated without any restrictions (no opt-out), thus the Polish proposal would create unjustified discrimination of patented NGTs vs. patented conventional crops.
In any case, this is a weak proposal. In the previous version by the Belgian Presidency (from 2024), NGT1 status would only be granted if no patent was filed. Now, NGT1 plants can be patented and the burden is put onto MS to prohibit their cultivation. This is no solution to the ongoing concentration / monopolisation in the seed market. Opt-out & labelling would not be a threat to companies, they will go on with the patenting. This proposal will raise many legal and political problems for MS and gives no legal certainty since the opt-outs can be revised any time by a (new) national government. The effects of this regulation onto the ongoing concentration of the seed market would be minor or zero.
A real solution on patents would entail 1) ensuring only genetically engineered plants can be patented, by clarifying the EU patent Directive 98/44; and 2) starting an initiative for a diplomatic conference to generally prohibit patents on plants and animals under international law (European Patent Directive).
The proposal from Poland does not solve other problems either: on risk assessment and the equivalence criteria of NGT1 plants (annex 1), there are some attempts to amend the Commission proposal. However, the Polish Presidency is still following the wrong idea that there might be a general threshold for effects caused by NGT processes, that would not go along with substantial risks. Meanwhile, many publications show there is no such threshold. Therefore, decisions on market access for NGT1 plants must only be taken upon case-by-case risk assessment.
Contact:
Christoph Then, info@testbiotech.org, Tel + 49 151 54638040
Further information:
The future regulation of NGT plants: Questions that still need to be answered