A year after the European Parliament voted to ban patents, EU countries still seek a compromise on NGT regulation
The revision of the regulatory framework for genetically modified plants currently underway in Europe aims to keep pace with technological advances and support the development of sustainable agriculture. The scientific community, the seed industry, and major farmers’ associations view the overall framework positively, but the devil is still in the details.
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While the number of studies on this topic is limited, they generally align in indicating that genome-edited plants are more appealing to the public than GMOs. Supporting this assertion is an analysis set to be published in the June issue of Current Opinion in Biotechnology. Hans De Steur and his colleagues at the University of Ghent in Belgium conducted a review of data collected from various countries worldwide, including Europe, Asia, and the Americas.
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There is no doubt that this is good news: on February 7, the European Parliament approved the Commission’s regulatory proposal on New Genomic Techniques, covering also CRISPR plants. Some of the approved amendments (particularly the one on genetic modification of polyploid plants) have the effect of improving the text, others risk being a problem and should be reconsidered during the trilogue with member states (particularly the requirement to label all final products, even if they do not contain foreign genes). The European Parliament also brought in the issue of non-patentability of NGT plants, which would deserve to be addressed elsewhere. For more information, this is the position expressed on February 14 by European Plant Science Organisation (EPSO).
Dear Members of the European Parliament,
In these times of climate crisis, biodiversity loss and renewed food insecurity, a scientific and evidence-based approach is essential in every respect. Now more than ever, we must rise above ideology and dogmatism. That is why we the undersigned turn to you and urge you to carefully consider the benefits of embracing New Genomic Techniques (NGTs) in your upcoming parliamentary decisions. As concerned citizens who believe in the power of science to improve our lives and our relationship with the planet, we implore you to vote in favour of NGTs, aligning your decisions with the advancements in scientific understanding. Conventional breeding for climate resilient crops (with cross-breeding of certain traits, subsequent selection and then backcrossing to remove undesirable traits) is too time-consuming. It takes years, decades even. We do not have this time in an era of climate emergency.
[Here you can read the full text of the letter and subscribe to it]
The news of the week is definitely this: the first clinical trial with base editing (the CRISPR platform used to chemically change single DNA letters without double-strand breaks) hit the goal of lowering cholesterol in patients but raised questions about the risks (with two serious adverse events, including one death), as Nature reports.
But we also recommend reading two other articles. Nature Biotechnology takes a look at experiments using CRISPR to eliminate viruses that manage to hide from the immune system, such as HIV and hepatitis. While Genetic Literacy Project publishes an analysis of the problems that could cripple the new regulation on edited plants proposed by the European Commission and delay (even until 2030) the arrival of the first products on the EU market.
The scientific community has warmly welcomed the proposal for partial deregulation of new genomic techniques put forward by the European Commission last July. Unfortunately, the legislative process will not be able to make significant progress before the next parliamentary term, which opens with the European elections in June 2024. However, this time will not be wasted if it serves to address a few problematic points and to finalise a few clarifying amendments. The devil is in the details: from the 20-nucleotide threshold proposed to delimit permissible interventions on the genome to the unknowns regarding coexistence with organic farming, not forgetting the stigma against herbicides. This article published in Nature Biotechnology by Belgian and German researchers is useful for going through the still unresolved issues.
The European Commission is collecting comments on the proposed regulation on New Genomic Techniques (NGTs) presented on 5 July. On this page you will find all the documents you need to form an opinion: from the criteria for establishing when a NGT plant is comparable to a conventional plant, to calculations on the costs of coexistence for organic producers (see in particular the Impact assessment report). The feedback received during the consultation period (8 weeks, extendable) will be summarised by the European Commission and presented to the European Parliament and the Council to feed into the legislative debate. In general, CRISPeR Frenzy appreciates the proposed regulation, especially for its focus on the promised benefits of NGTs in terms of environmental sustainability.
There is great disorder under the heavens of new biotechnology. Judging by the Italian debate on genetic innovation in agriculture, it seems that we no longer know what to call what. We are waiting for the European Commission to present its proposal to regulate ‘new genomic techniques’ (NGTs) on 5 July (see the leaked draft here). But in the meantime, on 9 June, the Italian Parliament approved a regulation in favour of experimentation with ‘assisted evolution techniques’ (TEAs), which are the same thing. However, if you read the official wording (9 bis, drought decree law) this expression is missing: instead, it refers to the deliberate release into the environment for experimental purposes of ‘organisms produced by genome editing techniques through site-directed mutagenesis or by cisgenesis’.
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On April 29, the European Commission launched an online public consultation on whether the EU regulatory framework should be reformed to keep pace with scientific and technological advances. The results, released on the consultation website, show a clear majority in favor of rethinking the current rules, which were approved when New Genomic Techniques (NGTs) such as targeted mutagenesis (i.e., CRISPR) did not yet exist. Here are the highlights:
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CRISPeR FRENZY 