The European Commission recently published a report on “new genomic techniques,” including CRISPR gene editing, which was expected to have major implications for their regulation in the European Union (EU). As of today, the EU is blocking the introduction of next generation crops, regulating them as GMOs, which means they’ve been all but banned under the continent’s ‘precautionary principle’-infused regulatory system.
Developers and supporters of gene editing technologies thought the report would accelerate the introduction of these products in the European market. However, far from introducing a strategy to end the European deadlock on these new biotechnologies, this report only announced further discussions. Further, EU political inaction may well comfort the leaders of China and the United States on these biotechnologies, two countries that are rushing to exploit these cutting edge tools.
New gene technologies hold promise in agriculture, industry and medicine, and the European Commission report recognizes this. In fact, the pioneering scientists involved with the most popular “gene editing” techniques (termed CRISPR-Cas), Emmanuelle Charpentier and Jennifer Doudna, were awarded with the 2020 Nobel Prize in Chemistry.
It cannot have escaped the attention of the Europe Commission that the continent is trailing far behind the US and China in all applied areas of these technologies. It is also obvious that the EU regulation of “GMOs” (a legal concept, often denounced by scientists as having no scientific or technical basis) has contributed to the backlash on these “GMOs”, which mainly are transgenic plants. There is at least one consensus in this dossier: if these “new genomic techniques” are regulated as “GMOs”, it will not be possible to develop them for commercial purposes in Europe, and costly obstacles will have to be overcome before import is authorized.
A previous European official report (in 2011) already stated that “The legislative framework as it operates today is not meeting needs or expectations, or its own objectives”. But nothing has been done to solve the problem at the EU political level. What happened was actually quite the opposite: the regulatory burden increased further, while leaving uncertainties about the future of new biotechnologies. Inevitably, when politicians are inactive, the power of judges increases, and this happened in the EU. In 2018, the Court of Justice of the European Union (CJEU) concluded that a broad category of biotechnologies known as “mutagenesis … are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.”
This means that these “new genomic techniques”, which often are “mutagenesis” techniques (they ‘surgically’ modify genetic traits), fall within the scope of the EU “GMO” legislation. The current report by the European Commission was expected to provide answers on how to overcome this major difficulty. It has not.
The pro-biotech side may be satisfied in the short term, because this report explicitly recognizes that products of new genomic techniques
… have the potential to contribute to the objectives of the EU’s Green Deal and in particular to the ‘farm to fork’ and biodiversity strategies and the United Nations’ sustainable development goals.
The EU’s proposed Green Deal has the ambitious aim to make Europe “the first climate neutral” continent. Reactions from supporters of organic and regenerative agriculture, who are unequivocally opposed to biotechnology, were negative. According to IFOAM Organics Europe:
A weakening of the rules on the use of genetic engineering in agriculture and food is worrying news and could leave organic food systems unprotected – including their ability to trace GMOs throughout the food chain to avoid contaminations that lead to economic losses and to live up to organic quality standards and consumer expectations. Organic producers urge the Commission and the Member States to maintain the existing regulatory framework and seriously consider the impact of the proposed regulatory scenario on organic food & farming, consumer choice and access to agrobiodiversity.
Slow food groups claimed that the “European Commission backtracks and opens the door to the deregulation of new GMOs, putting citizens and farmers’ freedom of choice at risk.” Comments like these confirm the interpretation that these new genomic techniques have scored points at the level of the European Commission.
However, nothing is settled by this report, and after more high–level European discussions the final outcome may be quite different, since the present balance of forces between Member States of the EU is apparently not in favor of biotechnologies, especially after the ‘Brexit’ of the United Kingdom (which is more pro-biotech) and the rise of the German Greens (who confirmed their opposition to biotechnology).
It is likely that these discussions will go on for a while. During the European Council meeting in Brussels on May 26 and 27, agriculture ministers from member states “held a debate on the conclusions of the Commission’s study on new genomic techniques and explored possible future policy actions”. The official summary of this debate is vague: “In general, they agreed with the findings of the study, notably the need to address legal uncertainty and to adapt the existing legislation to take into account scientific and technological progress”.
The continuing debate in the European Parliament will likely be plagued by ideological views, as shown by the first comments of Green MEPs criticizing herbicide-tolerant crops, ignoring the fact that these crops can be used in soil conservation agricultural systems.
The reason Europe is often at the origin of restrictions regarding biotechnologies and other technologies is deeply embedded. Much of these restrictions lie in the current framework behind EU members laws; called the precautionary approach. Europe relies on its “Big Principles” (democracy, rule of law, human rights, etc.) to avoid the repetition of the tragedies of the past (world wars, totalitarianism, genocide, etc.) and believes it has been successful on the continent. Similarly, following the same logic to avoid technological tragedies, Europe has invented other “Big Principles”: the participation of ‘citizens’, the Precautionary Principle (at the top of the hierarchy of norms) and a restrictive set of environmental laws.
It was thus unavoidable that these “Big Principles” found themselves at the center of the recent Commission’s report and it is unlikely that a majority of Member States will distance themselves from these views.
If some do so, it will be at a national level and this could well be a new step in a kind of European ‘deconstruction’. Actually, European GMO Directive (EU)2015/412 was already a first step in this direction in 2015. After 15 years of attempts at a common market and regulatory approach of biotechnology, Directive 2015/412 offers “the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory,” even when the organisms have been authorized at the EU level.
It also remains to be seen whether China, the US and other countries will benefit from such a more national approach, for example through bilateral agreements on biotechnologies with some European states.
Marcel Kuntz is a research director at the National Center for Scientific Research in Grenoble, France. This article is adapted from an essay published in Frontiers in Bioengineering and Biotechnology. This viewpoint does not reflect an official opinion of NCSR. Find Marcel on Twitter @marcel_kuntz
