Plant Innovation in Europe: Patents and GMO Regulation

Recently three key areas have attracted special EU attention: sustainability, biodiversity, and food supply and security. Sustainability is a key overarching priority, with the agenda requiring the reduction of agrochemicals and chemical fertilizers without compromising on yield.

It is imperative that adequate measures are put in place to mitigate the repercussions of climate change, including but not limited to drought and heat, with a view to ensuring food security.

The EU Biodiversity Strategy constitutes an extensive, ambitious and long-term plan with the aim of protecting nature as well as reversing the degradation of ecosystems. Another aspiration in regard to food supply and security is the promotion of healthier and more nutritious food options. This raises the question: How can these complex yet paramount goals be achieved?

The Potential of New Genomic Techniques

New Genomic Techniques (NGTs) are technology for altering the genetic material of an organism that have emerged or developed since the adoption of the 2001 genetically modified organism (GMO) legislation in Europe. One such NGT is CRISPR/Cas9, which has the potential to be applied across a broad spectrum of fields. It holds great promise for the realization of plant innovation. CRISPR/Cas9 employs artificially engineered enzymes, known as nucleases, that function as molecular scissors, effectively cutting the double-stranded DNA helix. This method allows for high-precision gene editing. Furthermore, CRISPR/Cas9 has been shown to reduce the innovation timeframe and enhance the efficiency of plant innovation to a significant degree. As a result, less time is spent for R&D to create a new plant innovation compared to both conventional breeding as well as older genome modification techniques.

By improving plant genomes, NGT-derived plants can have reduced need for pesticides and fertilizers. It is possible to enhance their resilience to climate change and diseases. They can also reduce food waste. Furthermore, NGT-derived plants have the potential to exhibit enhanced nutritional quality and increased yield productivity. NGTs have the potential to release agriculture from its dependency on external circumstances such as soil fertility or weather conditions which can make it a risky undertaking.

The Shift in Europe’s Traditional Stance Towards Genetically Modified Organisms

Europe’s regulatory framework reveals its traditional reluctance to embrace GMO, focusing on the risks and precautionary principles. However, the potential benefits of genetic engineering technology for the plant sector lately have been duly recognized. Indeed, there has been a shift in the European attitude towards NGT-derived plants, supported by the sustainability and food security agenda, and by the benefits of the NGT itself.

Although the use of NGTs alters the plant’s genetic markup, CRISPR/Cas9 is a type of NGT that does not introduce genes of foreign organisms (transgenic modifications); rather, it makes precise genome improvements within an organism itself. Therefore, some plants obtained through certain NGTs pose no greater risk than those improved using conventional breeding techniques. NGTs result in fewer unintended modifications than conventional breeding methods.

The Legislative Efforts of the EU

In Europe, three EU institutions are involved in the legislative process: the European Commission proposes legislation, followed by the European Parliament and the Council of the EU working together to adopt it. The European Commission is the executive body of the EU, which has the sole right to propose new EU laws while the European Parliament is the EU`s directly elected legislative body, that acts as a co-legislator, sharing with the Council the power to adopt and amend legislative proposals. The Council is made up of the heads of state or government of each EU member.

Marketing and release into environment regulation

Evidence of the change in the European stance reached a turning point with the European Commission’s proposal, supported by the European Parliament, which aims to enhance the regulatory framework for plants that have been modified using new genomic techniques. The proposal categorizes NGT plants as either Category 1 (those that could occur naturally or through conventional breeding methods) or Category 2 (those that cannot).

Category 1 plants would be regarded as equivalent to plants that have been obtained via conventional breeding methods, and thus would be exempted from the GMO legislation, and not be subject to labeling (except for seeds).

Should the proposal be enacted into legislation, it would significantly incentivize investment in Category I plants. Under the current stringent requirements for genetically modified plant marketing, such incentives are lacking.

Patent regulation

However, while the European Commission appears to be adopting a less stringent regulatory approach for NGT plants, the European Parliament has taken a contrasting position by proposing amendments to the Commission’s legislative proposal that would ban the patenting of gene-edited plants.

The rationale behind the drastic initiative to ban patents of NGT plants, plant material, genes used in these and process features is the concern that the relaxation of regulatory obligations mentioned above will potentially result in an escalation in patenting activity within the NGT agriculture sector. The latest circulated compromise text no longer contains a ban on patentability. Instead, it introduces provisions on patent transparency. As per the proposal, breeders who are applying for Category 1 NGT plant status would be required to report information on patents for the designated plant. Information on patents would be included in the public database.

Although the patent ban is no longer under consideration, it may already have conveyed certain signals to the agricultural industry. Nevertheless, the debate on NGT plants is essential, given its significance not only to the EU’s policy objectives but also to long-term sustainability. Indeed, the discourse following these legislative efforts analyses the potential future ramifications and the possibilities of implementing mitigating mechanisms to IP right web caused issues.

It is becoming evident that the IP rights landscape in the field of plant innovation is becoming increasingly complex, with implications for various stakeholders, including plant breeders and farmers. These complexities may hinder rather than facilitate innovation and access. Nevertheless, the abolition of patent protection for NGT plants is an excessive measure, with potentially deleterious consequences for innovation incentives. In scenarios where the patent and plant variety right landscape has become so complex, enhancing transparency with regard to rights and IP right ownership, and improving licensing mechanisms, may prove a more efficacious course of action. Furthermore, an advanced compulsory licensing regime could be an effective way of addressing licensing issues. Acting in the shadow of compulsory licenses can encourage market actors to reach voluntary licensing agreements more readily.

It is imperative that further steps be taken to adjust exceptions to patent rights and exceptions to plant variety rights and reassess whether the existing access mechanisms, such as compulsory license, farmer’s privilege and breeder’s exemption, are up to date and fulfill their intended function.

This post is part of a digital symposium called Innovation, Law, and Ethics in International Bioscience. To read the related posts, click here.

Acknowledgment: The research for this blogpost received support by the Novo Nordisk Foundation (NNF) through a grant for the scientifically independent Collaborative Research Program in Bioscience Innovation Law (Inter-CeBIL Program – Grant No. NNF23SA0087056).