The use of genetically modified organisms (GMOs) in Europe has been a controversial topic for decades. Now more than ever, the place of GMOs in a world increasingly committed to sustainability is being acknowledged, and with a changing environment comes changing regulations. Considering the European Union’s (EU) recent proposals for looser restrictions on gene-edited crops, we contemplate the broad implications of this change and the significance of patent protection in this discourse.
What are GMOs? A brief introduction
Genetically modified organisms (GMOs), are classed as a category of microorganisms, plants, or animals whose DNA has been modified using genetic engineering techniques. Genetic modification itself is not as new a concept as you might think. Since the first agricultural revolution, over 10,000 years ago, humans have been modifying the genomes of plants and animals through a process called selective breeding or artificial selection. Selective breeding refers to the genetic modification of a population without the addition of foreign DNA, by selecting individuals with desired traits (determined by their genetics) and breeding them with other individuals possessing the same desired trait.
This technique uses naturally occurring gene variants within a species and is therefore limited to what exists in nature already. Recent advancements in genetic engineering have enabled us to produce GMOs through methods once only read about in science fiction. Agricultural GMOs have been a hot topic of late, due to the rapid climate change we are witnessing. Now, laboratory-based techniques of gene-editing can be used to introduce new characteristics to an organism in a precisely targeted and specific way. Some practical examples of such characteristics include disease-resistance, herbicide-tolerance, improving a food’s nutritional value, and increasing crop yields.
The regulation of GMOs in the EU
The European Union is known for having some of the most stringent GMO regulations in the world. Currently, the EU has five approved GMO species: cotton, maize, oilseed rape, soybean, and sugar beet; a small number compared to the United States where many more GMOs are approved. The EU defines a GMO as “…an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” in Article 2 of Directive 2001/18/EC on the deliberate release of GMOs into the environment (European Commission, 2001).
A two-step risk analysis is the procedure used in the EU’s regulation of GMOs. First, there is a risk assessment conducted by the European Food Safety Authority (EFSA). Second comes the risk management step, performed by the European Commission (EC) and EU Member States. The competent authority in one of the Member States receives and assesses applications for the approval of GMOs for cultivation, import and processing. This is then submitted to EFSA where the application is assessed, and EFSA presents a recommendation to the EC. Based on this recommendation, the EC sends a proposal to the relevant EC Standing Committee consisting of representatives from all EU Member States. Here, the EC proposal is discussed, and a decision is reached by qualified majority voting. The original proposal may be resubmitted or sent to the Appeal Committee if no qualified majority for or against the proposal is reached. If the Appeal Committee also fails to reach a qualified majority, the EC will make the final decision.
On average, it takes six years from the time of submission until the final authorisation of GM crops for import. EFSA’s risk assessment phase is mostly responsible for this duration, as it typically takes almost 5 years for new products. Even so, if the GMO crops are approved, each Member State has the freedom to restrict or prohibit GMO cultivation in their territory. Initial GMO authorisations for cultivation are valid for 10 years maximum and are renewable.
Lifting some GMO restrictions on gene-editing?
A draft EU regulation put forward by the EC on the 5th of July has proposed the establishment of a category for plants genetically engineered to create new varieties expressing traits that could otherwise have been achieved via traditional breeding techniques. This is in a bid to support farmers in coping with climate change, and to forego the existing arduous and expensive GMO approval process. EU officials explain that plants produced by gene-editing techniques, such as drought-tolerant wheat and fungus-resistant tomatoes, are crucial in maintaining crop yields considering constantly changing weather patterns.
The deregulation of certain types of gene-editing is being proposed because genetic modifications resulting from the use of these techniques do not differ from changes that can occur without human intervention or by selective breeding. Once these gene-edited crops are released into the public realm, without prior knowledge of their genetic engineering, their lack of traceability through internal markets and across borders may pose a challenge. Distinguishing GM and non-GM supply chains from each other, while maintaining traceability, is difficult as detection technologies are currently either non-existent, unproven, unreliable, and/or expensive. The establishment of a mandatory international registry of GM products has been suggested, to provide comprehensive and authoritative information that would serve as a reference for systematic testing and detection.
Relaxing the regulatory grip on gene-edited crops may expedite their introduction to the market, thereby helping, for example, to reduce the use of fertilisers and pesticides which can have devastating environmental effects.
GMOs: a breeding ground for patents and licensing agreements
The legal systems governing the law surrounding both GMOs and patents are indispensable for the regulation and development of genetic engineering technology, and the commercialisation of genetically modified (GM) crops. Though both are important, they adopt significantly different approaches with separate goals in mind. GMO law is typically more restrictive, whereas patent law for GMOs operates more liberally in comparison, favouring the benefits of innovation. The two systems showcase the push and pull of attempting to exploit the advantages of genetic engineering techniques, while also safeguarding human health and environmental welfare.
GMOs are patentable under Directive 98/44/EC (1998) and the European Patent Convention (EPC). Gene sequences engineered for traits like herbicide tolerance or disease resistance in crops may in principle be patented and licensed for commercial use, allowing the patent holder to earn royalties on their invention by permitting its use by another party.
To relax or restrict: the polarising landscape of GMOs and patent law
The recently announced European Union regulation draft has revived conversations regarding how much EU member states may be willing to endorse the fast-developing gene-editing technology, and the subsequent effects of looser regulation on GMOs. Added to this is the hope that by solidifying the place of GMOs in the agricultural industry, farmers can be supported through climate change, thereby helping to quell rising food insecurity. The discussion around GMO restrictions and patent law raises questions as to what a positive outcome would look like between the two legal systems, and who may benefit the most.
There is the possibility that fewer GMO restrictions could increase the rate of patent acquisition for biotechnology companies as their genetic inventions may be allowed to be traded in the EU and therefore licensed to agricultural businesses for cultivation. This may afford such biotech companies more freedom to develop their inventions in Europe while publicly sharing technical information about it and inspiring further innovation in the field.
Relaxed restrictions on GMOs could also accelerate the authorisation of gene-edited crops for cultivation, import, and distribution.
Conclusion
The proposal for the new categorisation of GMOs may represent a vital step in the journey towards more widespread and varied cultivation of gene-edited crops in Europe. Relaxing GMO restrictions may present a steppingstone to a future of more sustainable and resilient agricultural systems. Although technologies of gene-editing are developing quickly whilst legal regulatory systems are following at their own pace, public perception and acceptance of GMOs in Europe remains a hurdle yet to be overcome. Yet, with softer rules authorising the cultivation of more GMOs under patent protection, more information will be publicly available and monitoring the effects of GMOs over time can fairly educate scientists, farmers, and consumers on these products. Given the circumstances, the proposal still requires approval from the European Parliament and EU member states and is subject to revision, but there is scope for extraordinary work to be realised – certainly, food for thought.
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