Genetically Modification Organisms (GMOs) is one of the most hotly debated topics in the news today. Resistance to GMOs has in the past been huge and strict regulations have followed. In July this year, the topic made headlines yet again when the European Court of Justice ruled that organisms obtained using modern forms of mutagenesis, such as CRISPR-based genome editing, are subject to pre-existing GMO legislation. At BioVox, we wanted to know how this scenario has come about; how an innovative and beneficial technology has become hamstringed by conservative legislation. Most of all, we wanted to know: what can we do now?
To answer our questions on GMO regulations, BioVox contacted three experts: René Custers is the Manager of Regulatory and Responsible Research at VIB. Roel Sterken is a biotech entrepreneur, active in both the biopharmaceutical and agricultural sector, and Willem Broekaert lectures at KU Leuven’s Centre of Microbial and Plant Genetics as a Professor of Biotechnology.
What happened in July?
All scientists and technology experts I have spoken to agree unanimously that gene editing is a useful option for the future. - Willem Broekaert
This July, after years of uncertainty about the regulatory status of genome edited organisms, the Court of Justice of the European Union (CJEU) finally came to a decision. They ruled that organisms obtained using mutagenesis are GMOs and that modern forms of mutagenesis, such as CRISPR techniques, are not exempted from the extant European GMO legislation. Experts have generally concluded that, as a result of this ruling, genome edited organisms, like CRISPR crops, are subject to onerous pre-existing GMO restrictions. Willem Broekaert explains the leadup to the decision:
“In 2001 the EU issued a legislation on GMOs called Directive 2001/18/EC. Only traditional GMO methods like transgenesis were included, with exceptions were made for some techniques, such as random mutagenesis. The directive was issued before modern techniques for directed mutagenesis (such as CRISPR) were even discovered.”
“The CRISPR system was selected by Science as 2015 Breakthrough of the Year. Around that time, nine French NGOs (hostile to all things biotech) initiated a court case in France to ascertain how new directed mutagenesis techniques, such as CRISPR, should be handled under 2001/18/EC. The French Council of State submitted the case to the Court of Justice of the European Union (CJEU) in October 2016. From that moment on, the whole matter became a pure legal issue: the only question was whether or not CRISPR falls under the definition of a GMO used in 2001/18/EC.”
From a scientific point of view, this makes no sense. It creates a regulatory situation that is disproportionate and discriminatory. - René Custers
René Custers agrees:
“The Court is not a policy body that can make political decisions: it is an independent legal body that rules on how EU legislation should be interpreted. The Court cannot study the biology of CRISPR and perform a risk assessment. It can only look at regulatory texts and provide its legal opinion on how that text should be read.”
Where to from here?
The July ruling means that CRISPR crop production and research is now tightly restricted in the entire European Union. Meanwhile, genome edited organisms continue to be used and developed in the rest of the world, while EU biotech falls further and further behind. So, what can be done about the situation?
“The CJEU ruling means that modern, directed forms of mutagenesis (such as CRISPR) are more heavily regulated than conventional forms of random mutagenesis, where the effects are far more uncertain. From a scientific point of view, this makes no sense. It creates a regulatory situation that is disproportionate and discriminatory. Most current applications of CRISPR generate small alterations that can also occur naturally. Additional problems are that (1) there are no technical means that can distinguish between a man-made alteration and a spontaneous one, and (2) that there is now regulatory disharmonization with other parts of the world, where genome edited organisms are not a regulated article. This calls for action. We cannot change the ruling, so if we want things to change, then we need to change the legislation itself. We should perform a more thorough evaluation of the EU GMO legislation and agree to something that is more science-based.”
Something has to be done to update the laws affecting the use of biotechnology in agriculture. The stakes are too high, and the true impact... will only be felt in another decade or two. - Roel Sterken
Willem Broekaert also feels that the legislation must change. But how?:
“All scientists and technology experts I have spoken to agree unanimously that gene editing is a useful option for the future. It has potential to contribute to more sustainable agriculture; experts all feel it is a real pity that CRISPR crop technology will be curtailed by the CJEU decision to classify it under the 2001/18/EC regulatory framework. However, there is less unanimity as to what to do next. Given where we now stand in Europe, there are currently two main options for moving forwards. Option one is to discuss an adaptation of the current 2001/18/EC regulation with the regulatory bodies, aiming to add CRISPR to Annex 1B which lists the exempted technologies (such as random mutagenesis). Option two is to go tabula rasa and draft a new, specific regulation for genome editing.”
Roel Sterken supports the consensus wholeheartedly:
“Something has to be done to update the laws affecting the use of biotechnology in agriculture. The stakes are too high, and the true impact of this CJEU ruling will only be felt in another decade or two. Political and legislative authorities need to show the courage and visionary leadership to listen to the scientific consensus when it comes to laws affecting use of science and technology in our society. Our political leaders have to realize the enormous impact the CRISPR ruling can have on our environment, society and economy, not just in Europe but on a global scale. Innovative projects to CRISPR-breed a new generation of crops that need less pesticides, less fertilizers, or that can withstand global warming, have come to an abrupt standstill. With science evolving at never-before-seen speeds, politicians need to follow closely by frequently reviewing and challenging the legislature that regulates these scientific activities.”
With everyone in agreeance that something must be done about Europe’s restrictive GMO regulations, the question now becomes: who will try to convince the lawmakers? The path to good quality legislature is a long and winding one; Europe is already falling behind. In addition to standing up for good science, we must also ask ourselves; how were these regulations passed in the first place? How do we prevent this scenario from happening again?