The EU’s Gene Editing Regulatory Dilemma

Scientists, grad students and fiscal research investments are all fleeing Europe

As consumers, we all want to be reassured that the products we purchase are safe for us to use and this is nowhere more important than in terms of the food products we buy. Consumers typically have a high level of trust in their food safety systems, but often fail to appreciate the costs that regulatory burdens bring to innovation and the supply of new and improved products. Recent research has shown that consumers that have low levels of trust in food safety systems also have low trust in innovative food products. Between 1992 and 2019, over 4,300 science-based risk assessments had been conducted on genetically modified food products, none of which have identified a risk level that differs from that of conventional food products. These risk assessments have been conducted by 70 different countries, 26 that grow GM crops and 44 that import them as feed/food. The nations of the EU have exhibited just that, having adopted an uber-precautious approach to the development of new food products, which is driving their brightest and best scientists and grad students to leave Europe for countries that support innovation.

In a recent article of mine published in the journal, Global Food Security, I highlight the EU’s reluctance to move away from its precaution-based regulatory system. Their reluctance to accept science is affecting not only in terms of the development of innovative crop varieties that will be better equipped to adapt to changing climates but also their ability to develop Covid-19 vaccines and have them approved.

Process-based regulatory systems are so 20^th century

In recognition of just how significant an innovation gene editing is, the two women that first discovered CRISPR/cas9, Jennifer Doudna and Emmanuelle Charpentier, won the 2020 Nobel Prize in Chemistry. Gene editing holds tremendous promise in the development of new crop varieties that can be more nutritious, higher yielding and better able to adapt to climatic changes. A recent survey of regulators and plant breeders found that only 6% believed that process-based regulatory systems are effective. In various parts of the world, gene editing is being applied to crops to improve yield, increase disease resistance, provide herbicide tolerance and improved oil and nutrient composition, including soybeans (drought tolerance, salt tolerance, high oleic acid, low trans-fatty acids), corn (increased starch), potatoes (lower acrylamide) and wheat (mildew resistance, higher fiber). Gene editing is a new breeding technique that changes specific genes by a precise level and doesn’t involve inserting DNA from another plant or species. Yet, the EU has decided to regulate gene editing as equivalent to breeding technologies that do insert DNA from other plants and species. Scientists have been frustrated by this decision, resulting in 117 research institutions within the EU signing a petition for modern regulations for gene editing technology. The current EU regulatory system for GM crops has only approved one variety for planting in the past 15 years, which was never commercialized due to the length of time it took to be approved, resulting in scientists being rightly concerned about the inability to get a new crop, fruit and vegetable varieties approved for production and consumption, given the existing failures.

By determining that gene-edited plants must be regulated as equivalent to GM plants and the broken regulatory system, this has set a precedent that all gene edited products will need to be considered within the GM regulation framework. This is where the EU has a real problem, in April The Economist reported that virtually all of the Covid-19 vaccines being developed in the EU are based on technologies that will make them GM products. It presently takes the EU regulatory system nearly 5 years to make an approval decision just to allow a GM variety to be imported for use as animal feed. The EU systems take far longer to assess risk, due to the precautionary basis, compared to other countries. For example, in Canada, a GM crop can be approved in 1-2 years of risk assessment. Science-based risk assessments assess the risk of a new GM product and if the risk of the GM product is comparable to the risk of an equivalent non-GM product, then it is approved. The EU lacks the ability to use this same equivalence as a rationale for approving GM products as safe. If the EU applies its process-based GMO regulatory framework to the risk assessment of GM-derived vaccines and drugs, it would be expected to have similar time requirements as GM crops to complete the process-based risk assessments. It is very doubtful the EU public would be willing to wait until 2025 to have access to a Covid-19 vaccine. In an admission that the EU regulatory system is a failure, the European Parliament announced it would ‘derogate’ some of the regulatory requirements that would be required of gene-edited developed Covid-19 vaccines to speed their development.

One technology – two regulatory systems

The EU is facing a situation where it may soon have two regulatory systems for gene editing. One that is science-based for the development of drugs and vaccines and one that is politically-based for plants. Should the EU move in this direction, it will demonstrate that if gene editing technology is applied to vaccines and drugs, the science is safe and the products can be approved. Yet if gene editing is applied to plants, the technology is unsafe and products should not be approved. Not only is this inefficient, but it also exposes the EU regulatory system to political manipulation from activist organizations. Scientists, graduate students and investment capital has been fleeing Europe for the past 20 years and the pace has increased in the past 2 years following the decision on the regulation of gene editing as equivalent to GMO regulations. The EU has been provided with a rare and unique opportunity to establish a product-based regulatory system that uses science, not politics, to make approval decisions. If the EU fails to take the appropriate actions and fix their broken regulatory system, the best and brightest of Europe’s scientists will continue to leave, agricultural innovation will be reduced and ultimately, food prices will increase.