Gene-editing: “Europe to make the most of the biotech revolution”

Gene-editing: “Europe to make the most of the biotech revolution”

Last year, I wrote calling for an end to the ideological bias that has driven the European debate around gene-edited plants , or New Genomic Techniques (NGTs). To this day, many policymakers and environmental groups continue to call for severe restrictions, if not outright bans, on their use.

Yet I am hopeful. Even if European countries have not yet embraced biotechnology in the way Kenya , Nigeria and most recently Thailand have – nations that recognize the potential of advanced plant-breeding techniques to improve food security and sustainability in agriculture – I am convinced that gene-edited plants will eventually be recognized in the EU to be as safe as conventional plants.

Yes, even in Europe.

As the European Union enters a new institutional cycle following the EU elections in June, I am encouraged by Commission President Ursula von der Leyen’s smooth re-election on 18 July for a second term in the European Parliament – a re-election that saw her take a strong majority. I am pleased that biotechnology has been given such a prominent place in her political guidelines for the next five years . President von der Leyen emphasizes that she wants “Europe to make the most of the biotech revolution”. She acknowledges that biotechnologies, supported by AI and digital tools, can help modernize entire parts of the economy, from farming and forestry, to energy and health.

For this to happen, a broad strategy for European life sciences and the necessary regulatory framework must finally be put in place. President von der Leyen intends to propose a European Biotechnology Act in 2025. We at Bayer will be happy to contribute to making the most of this for food security, healthy living and a successful Europe.

European Biotech Act creates new momentum for NGTs ???

The new push from Brussels to enable biotech in the EU more broadly will also create new momentum for EU governments to finally embrace NGTs, a precise form of gene-editing that targets specific genes, does not introduce genetic material from outside the original gene pool, and thus essentially offers an accelerated form of traditional plant breeding.

It was already a big step forward when von der Leyen’s outgoing Commission last year proposed to create new pathways for gene-edited plants to be placed on the market. The proposal was based on a more science-based approach – and, crucially, differentiated between NGTs and genetically modified organisms (GMOs).

Seeing the Commission aligned with many other countries worldwide in treating many NGTs similar to conventionally bred plants was already heartening. And I was again pleased in February, when the European Parliament in its vote on the draft law upheld many key science-based provisions in its position for the negotiations with the co-legislator, the EU Council (the EU member state governments).

Such developments seemed to me to resonate more strongly with Europe’s position at the heart of the Enlightenment – the movement that helped shape modern science as we know it.

Europe’s promising draft law is stuck with national governments – for now

But the NGT proposal’s arrival in the Council of ministers is where it has got stuck, at least for now. From its inception, the proposal faced a controversy about the issue of patents. And once in the hands of national governments, this topic proved a stumbling block, creating a preliminary deadlock in June.

The current Hungarian presidency of the EU has reopened the debate on several other fundamental elements of the draft proposal: most notably, it disputes the equivalence to conventional crops accorded to certain NGT crops, calls for mandatory labelling rules to be extended along the entire production chain, and seeks to significantly delay the legislation by awaiting the results of research projects that will take years to complete.

I called in my last 120 months article for “policy, not politics”. This call applies urgently to the field of NGTs: the ideological battle over the future of these vital products is still far from over.

However, at least this battle is now being transparently fought, as policymakers wrangle over paragraphs of a draft law in ministerial meetings and EU Council working groups. This is an improvement on fanning fears for political gain. Eventually, as is the case with most legislative battles in Europe, there will be a compromise, a result. I wish this could be done faster, but I am encouraged by the fact that there have been fewer fearmongering statements by politicians on NGTs in recent years than there were in the early days of GMOs.

Radical activism breeds vandalism

I call on European policymakers to not only avoid fearmongering, but to actively distance themselves from noisy and dogmatic activism in their countries. Radical activism feeds criminal vandalism. The most recent example of this is the deliberate destruction of a plantation in Italy where a gene-edited variant of Arborio rice was being trialled. This NGT rice trial, which aimed to develop a more fungus-resistant rice crop, would have been a landmark in sustainable agriculture by enabling farmers to reduce the amount of fungicide used in the fields.

A society tolerating such violent anti-science luddites will fall behind. Sabotaging the progress of sustainable agriculture is a senseless act of self-harm. Italy is one of the European countries whose farmers are suffering most acutely from the ravages of climate change.

Instead, consider the facts: crop yields are failing to keep up with population and demand growth, to a frightening extent (the last decade was the first in recent history where yield growth barely exceeded 1%); climate change is making agriculture increasingly challenging and unpredictable even in economically and technologically advanced countries; and the global population is forecast to continue rising considerably over the coming decades. The slow-down in yield correlates with a significant acceleration of annual temperature increases. Speed is one of the key benefits of the precision breeding enabled by NGT. To keep pace with climate change, we need to accelerate breeding efforts. Traditional approaches will fall short of enabling climate adaptation at scale.

Gene-edited plants offer “more crop per drop”

The need for speed is acute in Europe. To this day, at more than 30 million tons, the European Union is the leading global exporter of wheat. Through this, it helps feed 450 million people outside of Europe, predominantly in the Mediterranean region and countries like Bangladesh and Nigeria. While it is great to see food security higher on the agenda of the upcoming EU Commission, facts depicting the significant vulnerability of wheat to heat, and other climate excesses alone should motivate the EU member states to welcome new opportunities.

To this end, it is vital that farmers are equipped with all possible tools that can maximize their ability to feed the world – but are not wielded at the expense of the planet. Tools like NGTs, which have considerable promise in delivering crop varieties that require less water, fewer chemicals, provide more food security through increased yield and are more resilient to the conditions resulting from climate change. All this means that farmers get “more crop per drop” (in terms of both water use and chemicals) and higher crop yields per acre of land, resulting in savings for them, and healthier soils and a reduced rate of land-use change for our planet.

As a global leader in agriculture, Bayer for example has acquired a majority stake in the oilseed producer CoverCress . Field pennycress, an ordinary weed, was converted to a promising crop through breeding and gene editing tools. When incorporated into corn and soybean rotations during the winter, CoverCress can reduce nitrogen loss, sequester carbon in the soil, and enhance soil health.

Once commercialized, CoverCress will offer farmers in North America a lucrative cash cover crop with significant sustainability benefits. The oil derived from this crop is intended to serve as a new ultra-low carbon intensity fuel feedstock, especially for Sustainable Aviation Fuels (SAF), which is in short supply and urgently needed for the sustainable development of the aviation industry. CoverCress is cultivated over winter, when fields would otherwise lay idle. Thus, there is no competition between food and fuel. More so, CoverCress, as part of the crop rotation, further boosts food production. Imagine if European farmers and consumers could benefit from this innovation, too.

Pushed by the upcoming biotech initiatives of the next von der Leyen Commission, EU member states will have to face up to their clear responsibility: harnessing the power of science to solve the most pressing challenges of today. I am confident that rational voices in this debate will eventually succeed. ?

The issue of patents triggers disagreements

I recognize that the topic of patents triggers debate and that a balanced solution needs to be found. This discussion is as old as the concept of formal patents, first legally enshrined by 17th-century English and Venetian rulers and in the 18th-century US Constitution.

And still today, some critics of the patent system argue that patents are used to extract license fees and damage competitors, to the detriment of innovation and consumer choice. They often point to historical data suggesting that countries without patent laws have produced as many (quality) innovations as countries with patent laws.

But this is a flawed argument. This same historical data shows that innovation without some form of patent law can only flourish in an environment characterised by secrecy – i.e. when trade secrets are closely protected by a select few. Such a modus operandi is feasible in the modern world in some industries (packaged and processed food, for example), but not in all – and it certainly does not promote the transfer of knowledge, thus stifling further innovation and technological improvement.

As UCLA’s Kenneth Sokoloff and Yale’s Naomi Lamoreaux observed in a renowned 1997 paper , “[I]magine a world in which there was no patent system to guarantee inventors property rights to their discoveries. In such a world, inventors would have every incentive to be secretive and guard jealously their discoveries from competitors [because those discoveries] could, of course, be copied with impunity.” And, crucially, patents reassure investors – those funding the R&D programs that enable companies or research institutions to innovate – that there is value in innovation, thus ensuring the continued ability of R&D activities to flourish.

Plant variety rights are not the same as patents

Some EU legislators argue that NGT patents are already covered under the EU’s Community plant variety rights system, and thus no new legislation is necessary. This is not a viable solution, as current plant variety protections are relatively weak compared to patents, and only allow the entire plant – not individual traits nor technological processes in trait development – to be patented. Given the nature of NGTs, which make minute alterations to a plant’s DNA in order to yield subtle but powerful changes in its characteristics, such a blunt instrument is inappropriate as a standalone measure.

Without effective patent protection, product development and investment in R&D are not viable in the heavily-regulated life science sector. Acknowledging the global diversity of cropping systems, regulatory requirements and societal expectation, we collaborate with stakeholders all around the world to make sure they have access to the solutions they need.

Responsible application of patents is key

For example, we believe that small holder farmers and breeders should be exempt from paying licence fees to patent holders when using patented NGT materials and techniques. This is in line with our “health for all, hunger for none” mission that already guides our intellectual property position : Bayer does not file for or enforce patents in the Low-Income Countries (LICs) for human pharmaceutical products or vector control products, which are used to contain malaria transmission, nor do we enforce our IP rights for seeds against small holder subsistence farmers for private and non-commercial use.

We also offer small vegetable breeding companies in Europe access free of cost to our European patents on traits in vegetables which are in the Euroseeds PINTO database. and are working with other players in the sector to turn this into a sector wide initiative.

As with so many issues at the intersection of science and human interest, responsibility is key – be it policymakers’ responsibility to incentivize innovation, scientists’ responsibility to develop the solutions to global problems, or companies’ responsibility to wield their technologies and rights ethically and reasonably.

Unlocking Europe’s future: from Enlightenment to biotech leadership ?

Europe is not only facing major weather extremes, but also risks falling behind the US and China in the biotechnology sector. The EU must act faster to boost its competitiveness and climate resilience, as gene editing can help increase food security and sustainability, adapt to weather extremes, and bring tangible economic benefits to farmers, as the European Commission has long recognized.

EU governments must not waste more time and speed up its process – following the science for people and the planet.

Europe is seen by people and institutions around the world as the birthplace of the Enlightenment – and European governments and companies must live up to this legacy and drive science forward to the benefit of the future, rather than clinging to ideologies that shackle us hopelessly to the past.

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Juergen Eckhardt

Head of Leaps by Bayer and Head of Pharmaceuticals Business Development and Licensing. Executive Vice President, MD, MBA

3 个月

Great article, Matthias. CoverCress Inc. is an excellent example to mention here. I am truly impressed by its multifunctional approach—acting as 1) a cover crop, 2) a new low-carbon oil source, and 3) providing sustainability benefits by enhancing soil health.

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Bernhard L. Kiep

Managing Director at Bermad Brazil I Board Member at METOS Pessl Instruments, Christal, InstaAgro, InLida, Presidente MAIZALL

3 个月

Matthias Berninger hopefully Europe awakens and embraces biotechnology and help Farmers to evolve and perform a again in real sustainable way... including science and economics!

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Otávio Can?ado

Founder at De Lassus - Agribusiness Consulting Boutique | Consultoria em Agronegócio

3 个月

Send this issue to BR team. They can solve it. They do miracle.

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