Years of wrangling come to a (positive) conclusion
Following several years of deliberations, the European Parliament has adopted new regulations on new genomic techniques (NGT), which, however, still require the approval of EU Member States. This is currently regarded as a mere formality, meaning that the new EU regulation is expected to come into force in the course of 2028.
Cyprus’s Minister for Agriculture, Maria Panayotou, is therefore full of praise for the EU’s hard-fought decision:
“Our farmers need practical solutions to adapt to climate change and remain competitive. The new regulations give them access to innovation; at the same time, they ensure clarity, fairness and high standards across the EU.”
New genomic techniques
Behind this rather unwieldy title lie modern techniques for developing new plant varieties that no longer rely solely on traditional breeding methods – namely cross-breeding and propagation – but instead accelerate the natural mutation process in nature many times over through the additional use of CRISPR technology. Essentially, this involves cutting out individual gene sequences from conventional seed and modifying them in a targeted manner. The new EU regulation distinguishes between two groups:
– Category 1 (NGT-1)
These plants are regarded as equivalent to conventional varieties. National authorities verify their status; however, offspring of these plants do not require further testing. Category 1 NGT plants and products do not need to be labelled, provided they are not seeds or other plant propagating material. This allows businesses wishing to maintain NGT-free supply chains to do so. Certain traits, such as herbicide tolerance or the production of known insecticidal substances, are excluded from this category.
– Category 2 (NGT-2)
Plants with more complex genetic modifications. They remain subject to EU legislation applicable to genetically modified organisms (GMOs), including provisions on authorisation, traceability and mandatory labelling. Member States are free to decide against the cultivation of Category 2 NGT plants and to introduce coexistence measures to prevent them from inadvertently appearing in other products. In this case, the full labelling requirement remains in place.
Are the risks being underestimated?
When assessing the risks, it must be borne in mind that the varieties in the new NGT-1 category are ones that would also arise naturally, albeit over much longer periods of time. In this case, technology is merely mimicking nature. It quickly becomes clear that time is an immensely important factor when one considers how much humanity depends on plants that adapt to climate change, require less water and are more resistant to pests. Using natural breeding methods, their development would take decades. With the possibilities offered by gene editing, it is expected that the process can be shortened to just a few years.
The question remains as to whether the new varieties could pose risks to humans, as critics of the EU decision claim. Germany, in particular, stands out globally when it comes to hostility towards technology in general and genetic engineering in particular. It is not without reason that a lack of innovative drive and declining economic prosperity go hand in hand. However, whilst fully recognising the high standards of due care that can and must be demanded of legislation, it must be noted that, to date, no health problems attributable to the consumption of genetically modified food have arisen. Anyone who now believes that NGT-1 foods must be labelled as genetically modified must, by the same token, also demand this for products produced using fertilisers or pesticides. After all, these too interfere with a plant’s natural ripening process; the difference is that, in this case, the risks posed by residues have actually been proven and are, in some instances, significant.
What about patent protection?
This blog is dedicated to issues of intellectual property. So, what is the situation regarding patent protection for the new plant varieties soon to be developed?
It is, of course, incorrect to suggest that the EU is allegedly considering granting patents in this field for the first time, as is currently being reported in some print media. This is evidenced by the more than 1,000 intellectual property rights relating to CRISPR alone. The correct position is rather that the restrictions set out in the EU Biotechnology Directive and Article 53(c) of the EPC apply to patent protection. However, neither of these has ever excluded genetically modified plants from patent protection. It is possible, however, that this is simply a matter of misunderstanding: plant varieties are now (and will remain in future) excluded from patent protection if they have been produced exclusively through conventional breeding. Plant variety rights under the UPOV treaty from 1961 then applies. However, if the development of a new plant involves even a single microbiological step – this is where gene scissors come into play – it automatically falls within the scope of patent protection.
Yet the EU does not seem to have complete faith in market forces after all. The NGT Regulation introduces new transparency measures. Developers of Category 1 NGT plants must provide information on relevant patents in a publicly accessible database; furthermore, they may voluntarily indicate whether they are prepared to grant licences on fair terms. A point of contention here will certainly be whether farmers who purchase patent-protected NGT-1-modified seed are also permitted to propagate it without infringing the patent.
A new expert group is also to be set up to examine the impact of patents on NGT plants. Within one year of the regulation coming into force, the Commission will publish a study on the impact of patents on innovation, seed availability and the sector’s competitiveness, and propose follow-up measures if necessary.