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The Legal Framework – and the Proposals for Amendment

The Legal Framework – and the Proposals for Amendment

Photo: Adobe Stock / artjazz

In Europe, strict rules apply to research, development and approval of genetically modified plants. When these legal rules were created, genome editing techniques were not yet relevant. The present regulatory system does not do justice to the fact that these techniques are more precise than conventional genetic engineering and make it possible to breed varieties that could also be created by natural mutations or conventional methods. Scientists, therefore, see an urgent need for reform.

The main term used in the context of legal regulation of products created with the help of genetic engineering is “genetically modified organism” (GMO). This is how the European Union (EU) Directive on the deliberate release into the environment of genetically modified organisms, adopted in March 2001, defines the term: Plants, animals or microorganisms are considered genetically modified if their genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. The directive had to be transposed into German law, which therefore has a peculiarity in the choice of words. In the German legal texts, the abbreviation GVO is used and stands for “gentechnisch veränderter Organismus”.

The EU Directive contains regulations for the deliberate release of genetically modified organisms into the environment. With regard to green genetic engineering, the regulations thus become relevant once a plant developed in the laboratory is to be cultivated for field testing or when a company seeks marketing authorisation for a newly developed variety.

The current EU legal framework for GMOs is primarily designed to protect the environment and human health. It provides for a step-by-step approach. First, a GMO must be proven safe for the environment and human health in a closed system, such as in a laboratory or greenhouse. The next step is to allow field trials, first on a small scale and then on a larger scale. Only then may a genetically modified plant or its seeds be approved and subsequently marketed and used – the so-called placing on the market. Accordingly, the approval process is lengthy and cost-intensive because the extensive legal regulations for release and placing on the market must be complied with. An important principle of regulation is that a GMO product must be verifiably as safe as a conventional reference product.

European genetic engineering law is particularly strict by international standards. The regulations not only stipulate an elaborate approval process but in Germany, for example, they also entail liability risks for the farmers who cultivate such products. That is another reason why hardly any genetically modified crops are developed or cultivated in this country or other parts of Europe. This applies first of all to the products of conventional genetic engineering, which has so far mainly produced so-called transgenic plants – i.e. those to which the gene of an unrelated species has been transferred. A well-known example is transgenic maize (Bt maize), which, through the insertion of a bacterial gene, forms a substance that is lethal for insects.

Lawyer Professor Dr Hans-Georg Dederer on Genetic Engineering Law

Audio in German, English translation below

“The current genetic engineering law dates back to 1990. The decision was made then in favour of the process-related regulatory approach. However, this approach was already criticised at the time as being unscientific. The lack of a scientific basis is due to the fact that the regulation of genetic engineering is a risk regulation. It is about risks to the environment and human health. However, these risks do not arise per se from the procedure but only from the organism produced. That would be the plant bred in each case, the animal bred in each case, the microorganism created in each case, or in other words, from the organism produced, its traits and its application. This means that genetic or genomic modification procedures are not dangerous per se, in terms of themselves or by themselves. Essential for regulation from a scientific point of view is the link to the traits of organisms and the question for what purpose or how these organisms are to be used. The regulatory approach must therefore be linked to the product resulting from the process.”

Photo: Uni Passau

Furthermore, European genetic engineering law slows down the application of the newer genome editing methods. Compared to conventional genetic engineering, these methods have the advantage that they can precisely target the precise location in the genome where a modification is to take place. In particular, smaller gene modifications, such as deactivating a single gene, have become possible. This often results in minimal genetic changes (mutations), which could also occur by chance in nature or through traditional, non-genetic engineering breeding methods.

Genome editing can therefore be used to genetically modify plants without having to introduce genes from other, unrelated or cross-breeding species, as is the case with transgenic plants. Moreover, the technology known as genetic scissors uses the cells’ natural repair mechanisms and thus leaves no traces in the genetic material in most cases. If the genetic scissors are used to change individual building blocks of DNA (and not add a new gene), the result is usually genetically indistinguishable from conventionally bred plants.

European genetic engineering law is formulated in such a way that it primarily focuses on the process used and less on the product obtained. Therefore, genome edited plants – at least according to the current interpretation of the GMO definition by the ruling of the European Court of Justice (ECJ) from 2018 – are considered GMOs without exception and are thus subject to the same strict set of rules for risk assessment and approval.

The judgement of the European Court of Justice and its consequences

The case before the ECJ arose following a complaint by French agricultural and environmental associations. They had taken action against a regulation in effect in France, according to which herbicide-resistant plant varieties developed with a genome editing process do not fall under the GMO Directive because they were created by mutagenesis.

Mutagenesis is the artificial production of genetic changes (mutations) in the genetic material of living organisms. It can be done conventionally by irradiation or treatment with chemical substances. Since the development of genome editing techniques, mutagenesis is also possible in a targeted manner with CRISPR/Cas and similar technologies, such as the so-called oligonucleotide-directed mutagenesis, abbreviated ODM. When the EU’s GMO Directive was adopted in 2001, only conventional genetic engineering and conventional mutagenesis methods with decades of experience were being used. A specific exception for mutagenesis was therefore made in the Deliberate Release Directive. Organisms modified by mutagenesis, therefore, fall outside the scope of the directive.

The ECJ had to settle the question of whether this exception also applies to mutagenesis by genome editing. In their ruling, the judges ultimately upheld the plaintiffs’ position in the original case in France. They decided that organisms created by mutagenesis are in principle genetically modified organisms (GMOs), but that only GMOs modified by conventional mutagenesis methods (for example, with the help of radiation or chemicals) can be exempted from the obligations associated with the GMO Directive because such methods have been considered safe for a long time. However, since genome editing produces far fewer undesired mutations than traditional random mutagenesis, the ruling also revealed that current genetic engineering law is too undifferentiated and inconsistent with regard to the risks of the new processes and their products.

The criticism on the ECJ ruling and on genetic engineering law

The blanket legal classification of genome edited products as GMOs, as it ensues from the ECJ ruling, is not comprehensible from a scientific point of view. This is the conclusion of the German National Academy of Sciences Leopoldina, the German Research Foundation (DFG) and the Union of the German Academies of Sciences and Humanities. In their statement published in 2019, they argue that, with regard to genome editing, this neither takes into account which type of genetic modification was carried out, nor whether this change could also occur by chance or through traditional breeding methods. With the current legal regulation, organisms that carry one and the same genetic modification are regulated differently – depending on whether this modification has occurred naturally, through conventional mutagenesis or through genome editing.

The science academies and the DFG criticise that the primarily process-related regulatory approach in the EU is therefore not plausible. Potential risks can only arise from the modified properties of an organism – i.e. the final breeding product, and not from the process itself. The present approach to European GMO regulation does not correspond to the current state of research and leads to legal uncertainties regarding the use of new breeding techniques, the scientists emphasise.

The current regulation also raises the practical problem that analytical methods to distinguish in most cases between genetically modified plants resulting from random mutation, traditional breeding or genome editing do not exist. Agricultural imports cannot be analytically checked to determine whether they have EU-approval status or not. By contrast, detection methods are available for most products of conventional genetic engineering because they contain untypical gene sequences, for example from bacteria, which can be identified using analytical methods.

The fact that the ECJ ruling only exempts conventional mutagenesis methods from genetic engineering law is also inconclusive from a scientific point of view. Their precision is very poor compared to that of genome editing. The use of radiation or chemicals leads to far more undesirable effects – so-called off-target mutations – than genome editing.

Professor Dr Hans-Georg Dederer on Innovation and Genetic Engineering Law

Audio in German, English translation below

“Field trials have not been conducted for years in Germany and many other EU countries. It is also true that research and development, especially by the large seed companies, has shifted abroad, for example, to the USA. This is ultimately due to the product approval procedures, which are particularly time-consuming in the EU and therefore more costly than abroad. And why do these product approval procedures take so long? Because they are also highly politicised. In the end, the outcome is unpredictable. Accordingly, the risk of product development is far too grave if one might get stuck in the approval process in the final stretch. And that is the reason why European genetic engineering law ultimately hinders innovation and has also proven to be a hindrance to innovation.”

The statement by the science academies and the DFG points out that the current regulations on green genetic engineering hamper the transfer of findings from basic research into agricultural and horticultural practice and thus restrict scientific freedom. These research and development processes include, for example, field trials to research new traits such as stress or pest resistance in specific cultivation regions. There is a legal requirement to publish the testing location of field trials in a public site register. This makes vandalism by opponents of genetic engineering relatively easy to plan, as numerous wanton destructions of testing fields in the past have shown. Consequently, many scientists are reluctant to conduct field experiments with genome edited plants. In 2007, 78 applications for releases were submitted in Germany, in 2012 there were three, and there have not been any further applications since. Across the EU, the situation is similar: the number of releases registered with the competent body in Brussels/Belgium has fallen from 109 in 2009 to four in 2020. Field research with genome edited plants is increasingly moved to countries outside the EU.

Molecular Biologist Professor Dr Ralph Bock on the Consequences of Regulation

Audio in German, English translation below

“The primary victims of the regulation of genome edited plants as GMOs will be plant breeders in Europe, especially the small and medium-sized farms, which simply cannot afford to financially carry out a GMO approval procedure for genome edited plant varieties. It takes many years, costs millions of euros and only the few very large corporations can afford it like Bayer, Monsanto, BASF, Syngenta. And it is precisely the small and medium-sized breeding companies that will now be denied these revolutionary possibilities of the new technologies. They will have to accept a huge competitive disadvantage compared to foreign competitors.”

Photo: MPI-MP

Agronomist and Plant Geneticist Professor Dr Chris-Carolin Schön on Consequences for the Research

Audio in German, English translation below

“Field trials are indispensable for breeding. No candidate variety goes into marketing or production without being tested in the field. The tragedy of the current situation is that, on the one hand, we have very good new methods, but on the other hand, the legal framework is still so complex and complicated that it is hardly possible for us in the EU to test them in the field. This means we are doing very good research in a closed system, namely in the laboratory, and are also advancing promising new developments but cannot take them out into the field. So, under the current framework conditions, we cannot take the final research step into development and transfer.”

Proposals for an amendment of the genetic engineering law

In their statement, the science academies and the DFG conclude that it is urgently necessary to treat products created by the more precise genome editing methods different from transgenic products of conventional genetic engineering, to re-evaluate them and revise European genetic engineering law accordingly. As a first step, they recommend an amendment within a time frame of two to five years. In the longer term, they consider an entirely new legal framework to be necessary.

For a short-term amendment to the law, they suggest changing the GMO definition so that genome edited organisms no longer fall under genetic engineering law if no foreign genetic information has been introduced or their genetic material only contains changes that could also occur in nature or as a result of traditional breeding methods. In the long term, the scientists advocate a legal framework that provides for primarily product-related regulation. A starting point for regulation should be, for example, the novelty of modified traits.

Professor Dr Ralph Bock on the Need for Reform

Audio in German, English translation below

“The main issue at the moment is to lift the extreme burden of GMO regulation from simple mutations that have nothing to do with transgenes and are indistinguishable from the products of other mutagenesis techniques. Genome editing is a mutagenesis technique like many other conventional breeding techniques. Therefore, it makes therefore no sense at all to regulate it differently. And if this would be done, then genome edited plants would be exempted from the scope of the Genetic Engineering Act. This would be scientifically consistent because these plants do not contain transgenes. Many other countries have already decided to do the same thing. The USA, Canada, Argentina and other large agricultural nations have clearly stated that genome edited plants are not GMOs in the sense of the Genetic Engineering Act.”

The current status in the EU

In November 2019, against the background of the ECJ ruling on the classification of certain genome edited plants, the Council of the European Union requested the EU Commission to conduct a study to shed light on the status of new genomic techniques. This study was published in April 2021. It is based on contributions from experts as well as the competent authorities of the member states and so-called stakeholders at EU level. The study concludes that the current GMO legislation is no longer appropriate for genome editing techniques. At the same time, it highlights their potential to contribute to a more sustainable food system in the context of the objectives of the European Green Deal and the Farm to Fork Strategy.

The study does not directly lead to a proposal for legislative reform. It rather serves to prepare further political steps in which the options for regulating genome edited plants are examined. Against this background, the EU Commission initiated the amendment of the legal framework for genetically modified plants in September 2021 with a so-called preliminary impact assessment. It is the beginning of a multi-stage consultation process in which the advantages and disadvantages of potential political options are prepared to support the Commission in its planned legislative initiative. The entire process is designed to be transparent and enable citizens and stakeholders to comment on the Commission’s new approaches and contribute their own expertise.

In 2023, the Leopoldina and the German Research Foundation (DFG) published the ad hoc statements "Keeping Europe Up to Date – a Fit-for-Purpose Regulatory Environment for New Genomic Techniques" and “Für eine wissenschaftsbasierte Regulierung von mittels neuer genomischer Techniken gezüchteten Pflanzen in der EU”. These statements reaffirm their support for the draft regulation proposed by the EU Commission. They also emphasise in these papers that the planned ban on NGT-1 plants is inappropriate for organic farming. The organic farming sector could particularly benefit from NGT-1 plants due to the extensive avoidance of agrochemicals.

The EU member states must now position themselves on the draft regulation and, depending on the majority vote, clarify numerous details concerning its implementation. As it stands, the new regulation is expected to take effect at the beginning of 2026 at the earliest.

Regulations in other countries

There are already many countries where genome edited plants are regulated differently than products of conventional genetic engineering. Argentina was particularly early to take such a path. Meanwhile, other South and Central American countries, the USA, Canada, and Japan, followed suit.

Professor Dr Hans-Georg Dederer on Examples Outside the EU

Audio in German, English translation below

“The Argentinian regulatory authority understands the GMO definition to be more product-related, not primarily process-related like the European Union. Therefore, the national authorities ask whether the new combination of genetic material, as it results from a given process, is novel, truly new. They ask about the degree of modification of genetic material, in other words, how much the genetic material has been changed. This would actually be an exemplary approach for the handling of the GMO definition in the EU.”

Argentina introduced specific legal regulations for genome edited organisms in 2015. Since then, every new product has been subjected to a detailed examination to determine whether it is in fact a novel combination of genetic material and whether sequences of genetic material from other species have been introduced transiently or permanently. Here, only plants that actually contain a novel combination of genetic material fall within the scope of regular GMO regulation. Other South and Central American countries, such as Brazil, Chile, Ecuador, Guatemala, Honduras, Colombia and Paraguay, have also adopted this concept.

In the USA, the U.S. Department of Agriculture (USDA) decided in 2018 to take a particular approach to genome edited plants. Since then, at the request of plant breeders, the USDA has examined on a case-by-case basis whether a plant developed with the genetic scissors CRISPR/Cas or comparable technologies falls under the genetic engineering regulation of the Department of Agriculture. In principle, genome edited plants are not explicitly regulated as long as, for example, DNA sequences of plant pests have not been introduced into the plant genome. Therefore, changes to individual genetic building blocks are generally not regulated, as they are not seen as a potential risk. This regulatory practice was legally established in May 2020.

Professor Dr Hans-Georg Dederer on Regulation in Japan

Audio in German, English translation below

“Like the European Union, Japan regulates biotechnology comparatively strictly, and the public there is also very critical of it. In this respect, Japan is an interesting role model for the European Union. On the one hand, because regulation there is similarly strict, and on the other hand, the population there is similarly critical of genetic engineering. Nevertheless, Japan is currently moving in the direction of exempting certain genome edited organisms from regulation for the reasons already mentioned.”

Canada also takes a product-based approach to the legal regulation of genome edited plants. There, all plants that have a novel trait require approval for cultivation – regardless of the breeding method. A trait is considered novel, for example, if it is 25 to 30 per cent stronger or weaker than in a conventional reference variety. In Japan, genome edited products have been regulated separately since 2019. Here, such plants are subject to less strict rules if they do not contain foreign gene sequences produced outside their own cells.

Handling the labelling obligation

European genetic engineering law stipulates positive labelling: Food and food ingredients produced from or containing GMOs must be labelled accordingly. In addition, voluntary labelling for “GMO-free” food has existed in Germany since 2008. A green seal bearing the words “Ohne Gentechnik” (without genetic engineering) indicates that a product meets the relevant legal requirements for this labelling. Milk, for example, is considered free of genetic engineering if it comes from cows that are provided with GM-free feed.

Professor Dr Hans-Georg Dederer on Mandatory Identification

Audio in German, English translation below

“It is proposed to move from positive labelling to negative labelling. At the moment, the law stipulates positive labelling. This means that a product that consists of GMOs or has been produced from GMOs or contains GMOs must be labelled with the notice “contains GMOs” or “consists of GMOs”. This would be positive labelling. On the one hand, it has the purpose to inform the consumers and thus enabling them to exercise their freedom of choice. On the other hand, the mere fact that it is mentioned could give consumers the impression that the product might be risky in some way. And this can be avoided with negative labelling. At the same time, it would also take the freedom of choice into account. Negative labelling would mean that a product may be labelled “GMO-free” or “non-GMO product” on a voluntary basis if it meets certain criteria.”

This is also affected by the practical problem that it is often not possible to prove whether a product is genome edited or not. Therefore, the science academies and the DFG recommend that genome-edited products that do not contain any foreign genetic information or whose genetic material has only been modified in a way comparable to what could have occurred in nature or as a result of traditional breeding methods should be excluded from the labelling obligation. Companies which can prove that they do not use genetic engineering methods should still be able to label their products with the voluntary “without genetic engineering” label.

Are genome edited plants patentable?

Patents provide legal protection for technical inventions. Anyone who holds a patent has the exclusive right to use and exploit the invention for a limited period of time – usually 20 years. In return, the invention or innovation must be fully disclosed. Anyone who wants to use patented inventions commercially needs a corresponding licence from the patent holder. In principle, intellectual property rights can also be an incentive for innovation in plant breeding.

Professor Dr Hans-Georg Dederer on Patents on Genome Edited Plants

Audio in German, English translation below

“In principle, I would see patents as a good opportunity, because they promote innovation. After all, they are basically part of a deal, so to speak a reward for transparency. The invention is made public on the basis of the patent specification and thus further technical progress is made possible. In return, the inventor, the patent holder, receives an exclusive right, if only for a certain period of time and only concerning the commercial use of the invention. It is generally conceivable that a patent enables the monopolisation of an invention. But because the patent is only granted for a certain period of time, this is in principle less likely, as can be seen, for example, in the field of pharmaceuticals. There are no monopolies among research-based drug manufacturers. They are exposed to considerable pressure of competition from very successful generic drug manufacturers.”

According to the European Patent Office, plants that have been deliberately modified to show a new trait, such as improved resistance to pests or drought, are, in principle, patentable. Most of these are genetically modified plants. In the EU, the criteria for the novelty of plants are primarily regulated by the Biopatent Directive, which applies to biotechnological inventions. For an invention to be patentable, it must have sufficient inventive step and be industrially applicable.

New plant varieties created by biological breeding methods such as crossing and selection are not considered sufficiently technical from the legislator’s point of view and cannot be patented. Instead, plant variety protection exists in Europe and elsewhere, through which royalties can be charged for the commercial use of the propagating material of newly developed varieties for a period of mostly 25 years, exceptionally 30 years. However, other commercial breeders are usually allowed to continue breeding with a protected variety without needing permission. This regulation – called breeder’s privilege – is intended to ensure that continuously improving, novel varieties can be created without delay.

Professor Dr Hans-Georg Dederer on Patent Licences

Audio in German, English translation below

“Whether patents in the field of genome editing present more opportunities or risks cannot be said with certainty at the moment. The development here is ongoing. In principle, of course, if small and medium-sized enterprises want to make commercial use of an invention such as genome editing, and these inventions are patented, they have to acquire corresponding licences and pay the related licence fees. But this does not mean that monopolies are created. It only means that one may acquire an authorisation from the patent holder for a corresponding fee.”

Genome edited plants can be patentable inventions in the same way as plants bred using other genetic engineering techniques. One example of a potential patent in genome editing would be a specific process for producing herbicide tolerance in a plant. In this case, the process itself could be patented. However, it is also possible to patent a product, for example, a specific plant with a genetic sequence that produces herbicide tolerance.

There are legal pitfalls with patents on genome edited plants. It is conceivable that a seed company claims that a genetic sequence also present in a patented competitor’s product arose naturally in its variety. In patent infringement proceedings, it may not be possible to prove how the patented genetic sequence has evolved in the new variety.

If breeders want to develop new varieties using methods such as genetic scissors, patent protection for the genetic modification methods used must also be taken into account. In some cases, patent claims compete with each other. In the case of CRISPR/Cas9, a legal dispute between the University of California/USA and the Broad Institute in Cambridge/USA has been ongoing since 2014. The University of California claims the basic patent for the CRISPR/Cas9 method and the Broad Institute for its application to eukaryotes – i.e. living beings with a cell nucleus, including humans, animals, plants, algae and fungi.

In principle, patent protection is not a fundamental obstacle to research. However, licensing fees are due at the latest when varieties bred with the patented technology are to be marketed. It is expected that universities, as patent holders of genome editing methods, will be more generous in certain cases. The University of Wageningen/Netherlands, which also holds patents on CRISPR/Cas9, allows non-profit organisations to use the technology for non-commercial applications in the food and agricultural sectors free of charge.