Intellectual Property and New Genomic Techniques: Webinar Highlights

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Exploring the intricate domain of Intellectual Property (IP) regulations and their impact on crop breeding in Europe, the webinar ‘Impact of the IP System on New Genomic Techniques’ ignited engaging discussions among participants on 6 March 2024. 

At the heart of the webinar was the presentation of the recent ALLEA statement ‘Measures to Ease the Impact of the IP System on New Genomic Techniques for Crop Development‘. This publication outlines potential measures aimed at alleviating the challenges imposed by the prevailing IP system on NGTs. Following this presentation, two stimulating impulses further enriched the discussion, paving the way for an engaging exchange of ideas subsequently. The recording of the statement’s introduction, as well as the two impulses, is available below. 

The webinar served as a forum for an inclusive exchange of perspectives, with stakeholders from diverse sectors —including breeders, farmers, researchers, and policymakers— actively engaging in the dialogue.  

The participants explored the practicalities and possible consequences of implementing the diverse measures outlined in the ALLEA Statement, aiming to strike a balance between fostering innovation and ensuring equitable access to these technologies and their products. Various voluntary and legislative solutions were evaluated within the broader context of patent systems in place in other parts of the world and compared to the experiences gained in other fields of technology. 

Highlighting the importance of a nuanced approach, participants underscored the necessity of first conducting more thorough analyses regarding the possible positive and negative impacts of potential measures, especially also in the light of ongoing European endeavours to develop a new regulatory framework for NGTs.

ALLEA Holds Workshop to Depolarise the Debate on Sustainable Agriculture

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On 31 January, ALLEA and Re-Imagine Europa (RIE), its partner in the Task Force on Sustainable Food Systems and Innovation, jointly organised an invite-only workshop to discuss the increasingly polarised nature of the current debates on need for, and transition to, sustainable food systems in Europe.  

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ALLEA Releases Statement Addressing IP Challenges for Developing Crops Using New Genomic Techniques

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Today, ALLEA released a statement addressing concerns surrounding the impact of the current intellectual property (IP) system on the adoption and development of New Genomic Techniques (NGTs) for crop breeding. The outcomes will be further discussed during an open webinar on Wednesday, 6 March, 14:00 (CET).

The statement entitled, ‘Measures to Ease the Impact of the IP System on New Genomic Techniques for Crop Development’, examines how the current IP system affects the operations of European breeders and farmers, especially small ones. It provides a range of short-, medium-, and long-term recommendations to overcome possible obstacles posed by the current IP system.

Due to their potential to contribute to sustainable crop development, environmental safety, and food security, the enhanced precision and speed offered by NGTs, such as genome editing through the use of CRISPR-Cas, are considered to offer promising advancements in crop breeding  (see ALLEA’s work on NGTs for more information). However, the current IP landscape, which is governed through the European Union (EU) Biotechnology Directive 98/44/EC and the special Plant Breeders’ Rights, presents various challenges for breeders and farmers, including concerns about unintentional patent infringement, monopolisation of these technologies and the resulting plant varieties, and licensing complexities.

This statement highlights the increasing complexity of the patent landscape for NGT plants and products, which would arise primarily due to the increased speed in which new varieties can be produced, as well as the fact that plant varieties developed with NGTs may not be easily distinguishable from those generated by traditional breeding techniques. It also draws attention to the uncertainty arising from legal disputes surrounding patents on CRISPR-Cas9 technology. In addition, the lack of transparency and clarity in licensing agreements pose substantial obstacles to innovation and equitable access to these technologies.

In response to some of the challenges resulting from the current IP system, measures proposed in this statement provide a toolbox for multi-faceted solutions.

“The proposed short- and medium-term measures could be implemented relatively quickly and should help to alleviate some of the challenges for breeders and farmers by increasing transparency and access to these technologies. At the same time, however, it may be necessary to explore a more fundamental redesign of our IP system for food plants and related technologies in order to provide a more structural and future-proof solution.”

– Heinz Müller, Task Force Chair

This comprehensive statement on IP for New Genomic Techniques underscores the urgency of a nuanced approach. To arrive at these recommendations, a dedicated task force, consisting of leading experts on the topic, consulted with stakeholders representing a variety of perspectives, including patent holders, small breeders, academic researchers, and NGOs.

“With the increasing pressures on our food systems arising from climate change and geopolitical developments, collaboration among diverse stakeholders is paramount to securing the availability of sufficient and high-quality food. The proposed measures aim at supporting future European food systems that are more sustainable and serve the needs of our society.”

– Antonio Loprieno, ALLEA President

On Wednesday, 6 March, 14:00 (CET) a webinar will take place to discuss the outcomes of this statement, and further explore the implications of its recommendations as well as their potential impact in this field.

Read the full statement here

BRIDGING THE DIVIDE: Depolarising the Conversation on Sustainable Agriculture

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ALLEA Launches New Task Force to Investigate the Intellectual Property System for New Genomic Techniques

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When considering the potential of New Genomic Techniques (NGTs)  for crop improvement, such as genome editing using the CRISPR-Cas technology, (see ALLEA’s work on New Genomic Techniques), the protection of intellectual property (IP) rights is a critical concern. To address these issues in support of a more equitable system, ALLEA has established a dedicated Task Force consisting of some of Europe’s leading experts on the topic. 

At present, academic researchers and small breeders are concerned they are unable to fully benefit from these powerful technologies as they are typically being patented and monopolized by a number of big multinational companies. In addition, because the changes introduced by NGTs can often not be distinguished from those created by conventional methods, traditional breeders are concerned they might unwilfully infringe a patent that protects a variety they were developing over many years by traditional breeding techniques.  

In summary, the current EU patent and licensing system can be considered a clear competitive disadvantage for academic researchers and smaller breeders, and its complexity creates uncertainty for those willing to use NGTs and their products. The new ALLEA Task Force will therefore explore the central question:

How can we ensure that European researchers, small/traditional breeders, and farmers can avoid the unwilful infringement of patents and fully benefit from New Genomic Techniques and their products?

The Task Force met online for the first time on Tuesday 15 November 2022, and intends to present its findings and recommendations in an ALLEA Statement aimed at breeders, researchers, and national and EU policymakers. Several potential solutions will be explored, ranging from promoting increased transparency and skills to navigate existing patents and licences to possible recommendations for reforming the European patent system. The Task Force will listen to a variety of perspectives, including those from patent holders, small breeders, and NGOs, in their search for solutions that support a more equitable and balanced system. 

For detailed information on the Task Force’s composition, see the dedicated webpage.

ALLEA Provides Expert Advice to the European Commission’s Public Consultation on Plants Produced by New Genomic Techniques

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Today ALLEA, the European Federation of Academies of Sciences and Humanities, responded to the European Commission’s public consultation on plants produced by certain new genomic techniques (NGTs).

After providing feedback on the Commission’s roadmap in October 2021, ALLEA welcomes the opportunity to share more detailed input from the scientific community on the challenges related to the current regulatory system, as well as our vision for possible ways forward.

In its response, ALLEA stresses that the 2018 European Court of Justice decision “is a major setback for the development of useful new crops, including those with optimised traits to mitigate climate change and provide high-quality food for a growing population. The length and cost of the current authorisation process for NGTs is disproportional to the potential risks and makes it, except for major industrial players, de facto impossible to bring NGT seeds to our farmers”.

ALLEA states that “any future risk assessment framework should be science-based, considering not only potential risks but also the full spectrum of expected benefits to environment and society” and shares the Commission’s view that plants obtained by NGTs have the potential to contribute to the objectives of the European Green Deal and in particular to the Farm to Fork and Biodiversity Strategies. 

“We must take into account the unique challenges farmers are faced with in different regions and different sectors, as well as how our food systems continue to be affected by societal and geopolitical developments. Ultimately, farmers are best positioned to respond to these challenges, and they should be provided with broadest possible spectrum of technologies and seeds to support them”.

ALLEA also acknowledges the importance of providing clarity on when seeds and products are created using NGTs. “[…] farmers, producers and consumers should have a free choice to decide if they use or buy seeds and products created using NGTs. Transparent documentation will be important to guarantee autonomy and trust throughout our food systems.”

The response to the European Commission’s consultation reemphasizes key elements from the 2020 ALLEA report Genome Editing for Crop Improvement, which is based on expert discussions during the joint ALLEA and Royal Flemish Academy of Belgium for Science and the Arts (KVAB) symposium on the topic, as well as further work together with Re-Imagine Europa.

ALLEA Responds to European Commission Consultation on New Genomic Techniques

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On 21 October 2021, ALLEA, the European Federation of Academies of Sciences and Humanities, responded to the European Commission’s public consultation on ‘legislation for plants produced by certain new genomic techniques (NGTs)’. 

 

ALLEA has a long-standing interest in providing independent scientific advice to European policymakers and society. In this context, it has engaged in several activities that explore the potential applications and risks of genome editing for crop improvement. In its statement, ALLEA stresses that maintaining the status quo is not an option and welcomes the European Commission’s request for feedback on its initiative to develop new legislation for plants produced by NGTs, such as the CRISPR-Cas technology for genome editing. 

“[T]he increasing global demands (both in quality and quantity) on our food systems, as well as the challenges imposed on the agriculture sector by climate change, are huge and it seems unreasonable to exclude possible solutions that may allow opposing these challenges.” 

The response to the European Commission’s consultation summarises key elements from the ALLEA report “Genome Editing for Crop Improvement”, which is based on expert discussions during the joint ALLEA and Royal Flemish Academy of Belgium for Science and the Arts (KVAB) symposium on the topic in November 2019. Building on this report, ALLEA is currently participating as a knowledge partner in the cross-disciplinary Task Force on “Sustainable Agriculture and Innovation“, led by the European think-tank Re-Imagine Europa. The consultation response lists the desired attributes of an ideal regulatory system together with possible directions for future legislation, as described in detail in the task force’s recent White Paper on the Regulation of Genome Editing in Agriculture.  

ALLEA urges “NGTs to be considered an important tool for delivering on the goals of the European Green Deal and Farm to Fork strategy, whilst maintaining high health and environmental standards”, and emphasises the need to engage in constructive dialogue with stakeholders and European citizens on this contested topic. 

ALLEA’s full response to the European Commission’s consultation can be found here.

Genome Editing Beyond the EU: A Global Conversation

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On Tuesday 5 October, ALLEA participated in an online Expert Committee meeting of the Re-Imagine Europa-led Task Force on “Sustainable Agriculture and Innovation” to exchange international perspectives on regulatory systems for the application of new genomic techniques in agriculture.

 

Since the European Commission published its study on new genomic techniques in April 2021, it has become clear that a policy action on plants produced by targeted mutagenesis and cisgenesis is both necessary and forthcoming. Given this shift in stance from “if” to “how” the legislative framework should be changed, Europe must now consider how high health, safety, and environmental standards can be maintained whilst delivering on the goals of the European Green Deal and Farm to Fork strategy. 

In shaping Europe’s future regulatory approach, it is more important than ever that we learn from developments in other parts of the world. Therefore, the main objective of the meeting was to provide inspiration for policy directions that can provide proportionate, future-proof and resilient regulatory oversight, as understood in the Task Force’s White Paper on the Regulation of Genome Editing in Agriculture and in a manner that addresses the concerns identified as part of the narrative analysis detailed in the Task Force’s recent report Beyond the Apple of Discord: Existing Narratives and Ways Forward. 

The meeting was chaired by Dr Peter Kearns, Special Adviser to Re-Imagine Europa, and started with a keynote presentation from Prof Jennifer Doudna, Professor in the Departments of Chemistry and of Molecular and Cell Biology at the University of California, Berkeley and 2020 Nobel Laureate in Chemistry. In her presentation, Prof Doudna explained the role genome editing can play in counteracting the local consequences of climate change on our food systems, which comprise increased disease severity, lower crop yields, and decreased nutritive quality of food: 

“CRISPR-based solutions will allow farmers to adapt to a changing climate and sequester more carbon while preserving prized regional varieties. There is an incredibly important role for CRISPR in the protection of small farmers.”

On the other hand, Prof Doudna emphasized the importance of developing a robust ethical framework for CRISPR-based applications: 

“It will be crucial to create international standards and secure equitable access to the technology – for the immense benefits of CRISPR-based solutions to be realized, public acceptance is imperative, as is access to innovations.”

 

The keynote lecture was proceeded by six short interventions by international experts that shed their light on the different regulatory systems for genome editing in agriculture in key regions of the world: 

  • Dr Martin Lema: The Argentinean regulatory system and developments in the Latin American region
  • Dr Vibha Ahuja: Emerging regulations/policies for genome editing in plants in India  
  • Dr Peter Thygesen: Genome editing and regulatory developments in Australia  
  • Prof Masashi Tachikawa, Nagoya University: Genome editing in Japan: regulation and applications  
  • Dr Olalekan Akinbo, African Union Development Agency, Biosafety Network of Expertise: The status of genome editing in Africa.  
  • Prof Joyce Tait, UK Regulatory Horizons Commission and Dr Louise Ball, UK Department for Environment, Food and Rural Affairs: Genome editing and regulatory developments in the UK. 

During the open discussion that followed, the invited speakers and Expert Committee members exchanged their views and experiences on a wide range of topics, including: the challenges in finding the appropriate balance between innovation and precaution, how public opinion and stakeholder perception have shaped new legislation, how new regulatory systems can be designed to be future proof, and how differences between local regulatory systems might affect international trade.

The Task Force will continue to closely monitor the European Commission’s timeline for the development of a new regulatory system for new genomic techniques in agriculture and will continue to foster constructive dialogue on this contentious topic. For a complete overview of ALLEA’s work on genome editing for crop improvement, please visit our dedicated webpage.

The full programme of this meeting can be accessed here.

 

New Reports on EU Genome Editing Policy for Agriculture Presented

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On 22 July 2021, Re-Imagine Europa (RIE), together with knowledge partners ALLEA and EU-SAGE, presented two reports on innovation in agriculture in a virtual event. The publications look into existing narratives concerning the role of genome editing for crop improvement and potential ramifications for European policy.

 

At the event, titled ‘Beyond the Apple of Discord: Changing our Agri Culture’, science-policy stakeholders discussed the future of new breeding techniques, such as genome editing in crops, in moving towards sustainable European agriculture systems and in addressing climate and environmental-related challenges. Keynote speakers of the event included  Janusz Wojciechowski, European Commissioner for Agriculture; Norbert Lins, Member of the European Parliament; and Urs Niggli, President of agroecology.science. The event was chaired by Professor Louise Fresco, President of the Wageningen University.

 

Invited speakers: Professor Louise Fresco, Wageningen University (top left); MEP Norbert Lins, Chair of the Committee on Agriculture and Rural Development (top right); EU Commissioner for Agriculture Janusz Wojciechowski (bottom left); Urs Niggli, President of agroecology.science (bottom right).

 

The RIE-led Task Force on Sustainable Agriculture and Innovation aims to better understand the emotions and values behind different perspectives and to see if, with ambitious European climate, sustainability, and biodiversity goals as clear priorities, it is possible to find positive pathways forward.

During the event, the task force presented two reports that look at what we can learn from existing narratives and the potential implications for policy actions. For a short description of the task force and a summary of the reports, see “Overview of the Reports on Sustainable Agriculture and Innovation”. 

In the first report, “Beyond the Apple of Discord: Existing Narratives and Ways Forward”, the task force focuses on how different stories, symbols, images, and metaphors are used to inform the debate on the future of European agriculture. The report specifically describes the role of these emotions and narratives in framing the way we think about using genome editing for crop improvement. 

As stated by Prof. Louise Fresco, “Rather than focusing on the ‘apple of discord’ we should address the ‘apples of confusion’; there is a lot of common ground, but we must identify and address where the confusion lies.” 

 

 

The second report, “White Paper on the Regulation of Genome Editing in Agriculture” aims to describe the attributes of an ideal regulatory system that balances the need for embracing innovation in agriculture, such as new genomic techniques, whilst ensuring protection of human health, the environment, and biodiversity. The report also presents five policy options to be considered in the upcoming debate on genome editing between the Council, the European Parliament, and relevant stakeholders.  

In his opening remarks, Janusz Wojciechowski, European Commissioner for Agriculture, reassured that “For us it is crystal clear that any policy decision should protect human and environmental health. Making European Food Systems sustainable and resilient is one of our key objectives.” 

 

 

The task force is currently planning a follow-up meeting to be held in the European Parliament in Brussels in October/November 2021 (date and time to be announced and depending on Covid restrictions). This meeting will consider, amongst other things, how to further develop a shared vision for sustainable European agriculture systems and which policy options should be further pursued to achieve these goals.

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Call for Membership – European Group on Ethics in Science and New Technologies

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The European Commission has opened the public Call for Membership of the European Group on Ethics in Science and New Technologies, the independent advisory body established by the President of the Commission.  It is tasked with addressing all aspects of Commission policies and legislation where ethical, societal and fundamental rights dimensions intersect with the development of science and new technologies.

Since its inception in 1991, the EGE has provided the Commission with high quality and independent advice on manifold ethical issues. In the last three years, advice was provided on topics such as artificial intelligence (2018), the future of work (2018), COVID-19 and health crises (2020) and genome editing (forthcoming).

In addition to professional expertise, members should have a high motivation to serve the mandate of the EGE, be able and willing to provide wisdom, foresight and vision, to take the time to engage in in-depth collective ethical discussion in regular meetings in Brussels and online, to devise and draft analyses and recommendations, to build working relationships of trust and collaboration and to serve independently of other interests. They should offer a broad understanding of current and emerging ethical developments, including an understanding of the role and future of ethics in the EU context, combined with the capacity to engage with inter-, trans- and multi-disciplinary perspectives when addressing contemporary ethical dilemmas.

Interested individuals are invited to submit their application by 22 March 2021 (12:00 noon CET).

Read the full call