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Genome-Editing Products Line up for the Market: Will Europe Harvest the Benefits from Science and Innovation?

ABSTRACT: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technologies have revolutionized genome editing, significantly advancing the improvement of cultivated crop species. This review provides an overview of genome-edited crops that have either reached the market or received the necessary approvals but are not yet available to consumers. We analyze various genome-editing studies to understand the distribution of different genome-editing systems, the types of site-directed nucleases employed, and the geographical spread of these studies, with a specific focus on global and European contexts. Additionally, we examine the target crops involved. The review also outlines the multiple steps required for the legal acceptance of genome-edited crops within European jurisdictions. We conclude with suggestions for the future prospects of genome-editing research in Europe, aiming to streamline the approval process and enhance the development and adoption of genome-edited crops.

SUBMITTER: Polidoros A

PROVIDER: S-EPMC11353485 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Genome-Editing Products Line up for the Market: Will Europe Harvest the Benefits from Science and Innovation?

Polidoros Alexios A Nianiou-Obeidat Irini I Tsakirpaloglou Nikolaos N Petrou Nestor N Deligiannidou Eleftheria E Makri Nefeli-Maria NM

Genes 20240801 8

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technologies have revolutionized genome editing, significantly advancing the improvement of cultivated crop species. This review provides an overview of genome-edited crops that have either reached the market or received the necessary approvals but are not yet available to consumers. We analyze various genome-editing studies to understand the distribution of different genome-editing systems, the types of site-directed nucleases e ...[more]

PMID: 39202374

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Project description:Background: Many established products (EPs - marketed for eight years or more) are widely used off-label despite little evidence on benefit-risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies. Methods: Targeted literature search and expert panel meetings. Results: Within the current European-level and national-level regulatory framework there are limited incentives for development of new indications with EPs. Extension of indication normally does not allow the price to be increased or maintained, the market protection period to be extended, or exclusion from a reference price system. New indication frequently triggers re-evaluation, resulting in price erosion, regardless of the level of added value with the new indication. In consequence, manufacturers are more prone to undertake R&D efforts at early to mid-stage of product life cycle rather than with EPs, or to invest in new chemical entities, even in therapeutic areas with broad off-label use. This represents a potentially missed opportunity as developing new indications for EPs offers an alternative to off-label use or lengthy and expensive R&D for new therapies, opens new opportunities for potentially cost-effective treatment alternatives, as well as greater equity in patients' access to treatment options. Conclusion: There are potential benefits from the development of new indications for EPs that are currently not being realized due to a lack of regulatory and pricing incentives in Europe. Incentives for orphan or paediatric drugs have proven to be effective in promoting R&D. Similarly, incentives to promote R&D in EPs should be developed, for the benefit of patients and healthcare systems.

Project description:The Lisbon Strategy was adopted by the Heads of State and Government of the European Union (EU) in 2000. By moving science into a central position for the development of a European knowledge-based economy and society, its adoption at political level seems to have been a powerful catalyst for the increased involvement of scientists in science policy in the EU. Recognising the need for scientists to act collectively in order to contribute to shape the future of science policy in Europe, a pioneering group of European science organisations leaders and representatives, as well as other scientists, initiated a European, interdisciplinary, inclusive movement leading to the creation of the European Research Council (ERC) to support basic research of the highest quality. Having scientists' campaign for the funding of bottom-up research by the EU Framework Programmes exclusively on scientific grounds, and for an ERC, was a unique event in the recent history of European science policy. For the first time, the scientific community acted collectively and across disciplinary or national boundaries as a political actor for the sake of a better science policy for Europe. As is often the case when first-hand experience is gained through the creation of a new organization, novel forms of collaboration arise. The European biomedical community has recently proposed the creation of a strategic action plan for health research (the European Council of Health Research; EuCHR), provisionally translated at present into a Scientific Panel for Health (SPH) research in Horizon 2020, the EU's research-funding programme for the period 2014-2020. The creation of such Scientific Panel should be viewed as an important contribution by the biomedical community as a major political agreement has been reached on the need for a comprehensive and long-term scientific strategy to accelerate research and facilitate innovation at EU level. It is our belief that describing and analyzing the process leading to the creation of the ERC and SPH (2002-2014) should be widely shared with the research community in general, as this may contribute to the understanding of the evolving relations between scientists and science-policy making.

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Genome-Editing Products Line up for the Market: Will Europe Harvest the Benefits from Science and Innovation?

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Genome-Editing Products Line up for the Market: Will Europe Harvest the Benefits from Science and Innovation?

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