The impact of the recent ECJ ruling on plant breeding innovation.
Many members of the plant breeding sector in Europe are voicing their opposition against the July 25 ruling which states that crops obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.
The ruling of the European Court of Justice (ECJ) subjecting some of the most promising of the latest breeding methods to the EU’s rules and regulations for GMOs is the talk of the town amongst the plant breeding and even wider agricultural community. Seed World sat down with Garlich von Essen, Secretary General of the European Seed Association (ESA), to discuss its consequences and impact.
Seed World (SW): Looking at the international media reactions and published statements, it seems the ECJ’s ruling apparently has come as a big surprise to most observers.
Garlich von Essen (GVE): That is true. I think it is fair to say that many expected the Court to follow the opinion of its Advocate General Bobeck who had taken a very different approach in his interpretation of the relevant EU Directive. In most of the cases, that is what the Court does: follow the Advocate General and add further details. And of course, the intervening Member States like the UK or Sweden as well as three EU institutions, foremost the EU Commission, basically all argued that a differentiated view should be taken. In the end, the Court opted for a very static interpretation of the letter of the law rather than a forward looking, more dynamic one as suggested by the Advocate General and others. It took an extremely conservative, legalistic approach. You could call it playing it safe.
SW: What direction of regulatory clarification was the industry hoping for?
GVE: The seed sector in Europe had hoped for a clarification that finally acknowledges that these technologies can be applied in different ways, leading to different results that may be treated differently by the regulator. While some lead to a regulated GMO, others do not. This differentiation can only be made when we do not solely look at technologies but also consider the final outcome of the process, i.e. the final plant product. It is the approach most other countries all over the world are now following as they realize that the rather simplistic approaches of the old GM rules are not fit for purpose for the next era of plant breeding innovation. Unfortunately, the judges overturned the opinion of Advocate General who had proposed exactly such a more differentiated, more end result-oriented interpretation of the EU legislation.
SW: So, this is it then – or are there any possibilities to appeal this ruling and get a different outcome?
GVE: There is no appeal procedure to an ECJ preliminary ruling; the ruling’s interpretation of the Directive on those four questions submitted by the French Court stands. And any similar or related potential cases would be interpreted on the base of the interpretation given in this one. The problem is that science, unfortunately, has been pretty much absent and widely disregarded in this case. That has led to a ruling that may make sense from a purely legal point of view but that doesn’t make sense if we look at the biological facts as well as the technological developments. Why would we consider it necessary to regulate the same product by two different sets of rules? And how do we practically enforce rules that will consistently be challenged; not by man but by nature itself. It seems that more and more people start to see that it is probably not the ruling itself that is the problem but what it is based on: scientifically outdated concepts determining legal rules that today prove to be too narrow to be able to keep pace with a changing reality.
SW: Will the ECJ’s ruling now stifle plant breeding innovation in Europe?
GVE: The commercial release of any new variety obtained by advanced mutagenesis breeding methods now requires the regular EU GMO risk assessment clearance which constructs an immense financial hurdle that effectively rules out applications for any smaller market or species. Today, no applications for cultivation of GMOs are pending in the EU. Not only is the authorization procedure notoriously cumbersome and slow; it also is completely politicized with Member States now having the right to ban the cultivation of GMOs on their own territory even following an EU level approval. Before this background, a wider introduction of new varieties developed with latest breeding methods is both financially as well as practically impossible.
And we should not forget the impact on further research! Field trials with plants classified as GMOs have basically ceased to exist in Europe. We must now expect that the same will be happening to research projects involving advanced mutagenesis breeding. With that, also public research into Plant Breeding Innovation (PBI) applications will largely come to an end as crucial industry co-funding will dry out and public-private partnerships lack the necessary economic basis. This will have dramatic consequences for product development for Europe.
SW: So, you expect Europe to lag behind other regions?
GVE: Yes. Europe will start to lag behind. The only question is at what point in time this will become fully evident. Companies will quickly concentrate PBI related R&I activities outside of Europe. It is likely that this will go hand-in-hand with a refocusing of overall elite germplasm and variety development to those regions that are already embracing the new breeding methods and are gearing their respective regulatory frameworks to support this. But what is worse is the fundamental message the ruling sends to anybody considering a career in plant sciences in Europe: you’re not welcome here! That may prove the most devastating effect in the long run.
SW: What impact do you think the decision will have on importers of GMO food and feed? And do you think the decision will have any impact on future trade negotiations (since agriculture usually is a sticking point in all such discussions)?
GVE: It is probably a bit too early to fully understand and predict the consequences. It is a fact that the EU approval system for GM food and feed imports already today is largely dysfunctional. Member States disregard the opinion of the EU’s competent scientific authority European Food Safety Authority (EFSA) and generally fail to approve any new product according to the applicable rules and procedure. Similarly, the European Parliament passes (non-binding) resolution after resolution asking the Commission NOT to apply the legislation and in the absence of a decision by Member States- approve the import authorisation based on the safety confirmation of EFSA. All of this tit-for-tat has resulted in a continuous backlog and undue delays — with the known negative consequences for the international trade.
With the new methods, things will be very different. First, most countries other than the EU do not consider them to result in regulated GMOs. This means we have a fundamental difference already at the starting point. And if the new breeding methods are therefore taken-up worldwide and at the pace and breadth we predict, this will quickly result in dozens and probably soon hundreds of new varieties in many, many different species. All of these will be considered conventional in the countries they will be grown in. Even if these countries would acknowledge the EU’s different interpretation: such a massive influx of import applications can never be handled by the current EU system. It simply lacks both the necessary resources and the political will.
SW: Bayer, BASF and probably some others, already announced that they will not pursue advanced genetic plant breeding any more in the EU. Are you seeing more companies/inventors saying this too?
GVE: I would expect that this position will become the rule, not be an exception. It also needs to be said that such relocation of PBI related R&I activities (and consequent product development and marketing) will be easier for those entities that already possess respective facilities outside the EU. The smaller and more regionally or even locally focused European companies are the ones that will suffer most. It is sad to see that history seems to repeat itself. We already observed this effect with the classical GM technology and products. Those now applauding the ruling as preserving a diverse European plant breeding sector will in the end see that quite the contrary will become true. Only larger companies would be capable of crossing the high regulatory and financial bars of the EU’s GM authorization system. Smaller and medium sized companies will effectively be prevented from accessing these advanced breeding methods.
SW: What next steps will ESA now be taking?
GVE: Of course, we are still in the process to fully analyze the ruling and all foreseeable consequences. And we will discuss these also with our colleagues in public research, our customers, the European farmers and vegetable growers, as well as our partners along the EU agri-food chain. The very clear and unusually outspoken reactions of many of them show that there is a wide agreement amongst us that this ruling now has to be accepted from a purely juridical point of view; but that its wider socio-economic consequences are unacceptable not only for us but for Europe as a whole. To turn an old saying around: If it’s broken, fix it! How it can be fixed to me is still uncertain and will still require long and difficult discussions. But that we will try to fix it, that much is for certain.
What is equally clear is that Europe in the first place needs to have a political debate, not a legal one, on the future of its agriculture, its related sectors in general and specifically on plant breeding innovation. Maybe the start of discussions about the new European Common Agricultural Policy and related budget provides an opportunity for that; and maybe the severe drought problems in vast parts of Europe underline the importance and the urgency to set Europe’s plant breeding sector free from rules that prevent instead of stimulating innovations that could help us to more successfully address climate change, healthy diets, environmental sustainability and food security.
It is not yet too late to have this debate; but it is high time. 150 years after Mendel’s discoveries revolutionized the understanding of the development of plants, we will do all we can to assure that Europe not only has a history of plant breeding to be proud of, but that it also will have a future.