The Polish Presidency has prepared a compromise proposal for the Council's position on the Commission proposal concerning plants obtained using certain new genomic techniques (NGT). They have stated that addressing the concerns linked to existence of patents on plants obtained by NGTs was a way to reach to qualified majority, which aim to strike a balance between safeguarding patent protections and ensuring breeders’ access to plant material, the proposal includes clearer definitions on what a “category 1 NGT plant” is, and drawing sharp lines between product patents (covering plant traits) and process patents (covering the enabling technologies).
It recommends distinguishing two cases of patented NGT plants. If the patent relates only to the use of “basic technologies” for genetic modification, the variety may be placed on the market following the simplified procedure applicable to NGT plants “similar to conventional” (Category 1). If the patent concerns the final product, i.e. the genetically modified variety, or the introduction of specific characteristics, for example drought resistance, the seed will be subject to additional rules, such as a labelling indicating “patent protected”. In addition, Member States would have the possibility of restricting or prohibiting the cultivation of such a variety on their territory (opt-out). It also proposes the creation of a procedure to verify the existence of patents on NGT plants.
The amendments suggested consist notably in:
- Add definitions of patents, product patents and process patents and introduce a procedure for verifying the existence of patents for Cat 1 NGT plant reproductive material.
- Differentiate between process patents protecting basic technologies and process patents that result in a specific characteristic (trait) for the marketing of Cat 1 NGT plant reproductive material.
- The reproductive material of Cat 1 NGT plant may only be placed on the market without any restriction if not protected by products patents or process patents.
- The reproductive material of Cat 1 NGT plant if protected by patents might be subjected to restriction or prohibition (opt-out) by a MS for its cultivation, on the basis of socio-economic impacts or agricultural policy objectives.
- Introduce a procedure for verifying the existence of patents on Cat 1 NGT plant reproductive material: anyone wishing to place reproductive material from a Cat 1 NGT plant on the market must submit a request to the Commission, which will have to provide a verification report and then a formal decision concerning the non-existence of patent protection (or patent application) on the products or processes relating to the plant in question.
- A label requirement is introduced of patented Cat 1 NGT protected by patents – remaining limited to reproductive material.
- The Commission may launch the revocation of the patent decision.
Furthermore:
- With regard to the status of Cat 1 NGT plants (Article 5), the Polish Presidency is proposing to maintain the ban for organic production.
- With regard to the procedure for verifying the status of a Cat 1 NGT plant (Articles 6 and 7), the Polish Presidency wishes to make the declaration of Cat 1 NGT status conditional
- In addition, the Polish Presidency confirms that the development and use of NGT plants that include tolerance to herbicides among the intended traits conveyed by the genetic modification should be followed up and these plants should remain subject to authorization, traceability, and monitoring requirements. Therefore, NGT plants that include tolerance to herbicides among the intended traits conveyed by the genetic modification should be subject to the provisions for Cat 2 NGT plants.
- With regard to the opt-out clause (Article 25), the Polish Presidency proposes deleting Article 25, which states that the opt-out clause (provided for in Article 26b of the GMO Directive) does not apply to Cat 2 NGT plants, opening therefore the possibility for MSs to opt-out for Cat 2 NGT.
Background:
On 5 July 2023, the European Commission adopted a proposal for a new Regulation on plants produced by certain new genomic techniques (NGTs) which include advanced methods of gene editing, such as CRISPR-Cas9. These techniques hold promise for advancing agriculture, improving food security, and addressing environmental challenges. The EU's proposal aims to update existing biotechnology regulations to provide a more streamlined framework for their application, while ensuring safety and transparency.
The key elements of the proposal include:
Risk Assessment: Any organism produced using NGTs will undergo a comprehensive risk assessment to evaluate potential impacts on health, the environment, and biodiversity. This would ensure that the modified organisms are safe for release and consumption.
Traceability and Labeling: The proposal emphasises the need for clear traceability and labeling of food and feed products derived from NGTs. This is intended to maintain transparency and enable consumers to make informed choices.
Sustainability Goals: The EU recognises the potential of NGTs to contribute to sustainability in agriculture, including improving crop resilience to climate change, reducing the use of pesticides, and enhancing food security.
Scientific Oversight: A robust scientific framework is proposed for monitoring and evaluating the use of NGTs, ensuring that research and applications align with EU values and safety
The proposal is accompanied by an impact assessment, supported by an external study, JRC case studies on several applications of NGTs and the scientific work of EFSA in the area of new genomic techniques.
Organic:
NGT plants will be prohibited in organic production. For NGT plants subject to authorisation, the legislative proposal maintains the traceability and labelling requirements of the GMO legislation. Today, GMOs are banned in organic production by the EU Organic Production Regulation. In addition, the proposal makes the adoption of coexistence measures at national level mandatory. Member States must adopt measures so that different types of cultivation can exist side by side, e.g., distances between the fields.
To exclude NGT plants from organic production, even those that have been verified to be comparable to conventional plants, organic and GM-free farmers can consult a public register of all NGT products and seed labelling in common catalogues of varieties.