Future-proofing regulation for rapidly changing biotechnologies

Abstract

Our understanding of DNA structure and how it interacts with the environment to give form and function at the organism level is growing at an unprecedented pace which shows no sign of slowing. These developments have already led to many new products and will continue to underpin as yet unpredicted future developments in biotechnology. However, this potential will not be realised unless the mechanisms for risk assessment, regulatory approval, product claims and labelling etc. are fit for purpose, have the confidence of all stakeholders and are sufficiently agile to support this rapidly changing field. The sectors that are making particular advances in biotechnological processes include agriculture, pharmaceuticals, food, chemical and human diagnostics and therapeutics. In many of these areas the research, investment and innovation pipeline is operating well as evidenced by the many marketed products. However, developments in plant breeding methods have posed particular challenges for regulators which in turn is stifling R&D and innovation, particularly in the EU. In rapidly moving areas of research and development, it is imperative that regulatory frameworks are future-proofed by design.

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References

  1. EASAC (2017) Genome editing: scientific opportunities, public interests and policy options in the European Union. https://www.easac.eu/fileadmin/PDF_s/reports_statements/Genome_Editing/EASAC_Report_31_on_Genome_Editing.pdf. Accessed 28 Oct 2018

  2. EFSA (2012) Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function. EFSA J 10:2943

    Article  CAS  Google Scholar 

  3. ENA (2018) European Nucleotide Archive reads growth to 29th Oct 2018. https://www.ebi.ac.uk/ena/about/statistics. Accessed 30 Oct 2018

  4. EOP (2016) National strategy for modernizing the regulatory system for biotechnology products. [January 31, 2017]. https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf. Accessed 28 Oct 2018

  5. EOP (2017) Executive office of the President. modernizing the regulatory system for biotechnology products: an update to the coordinated framework for the regulation of biotechnology. [January 30, 2017]. https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf. Accessed 28 Oct 2018

  6. FAS.USDA (2018) USDA world production, markets and trade reports. https://www.fas.usda.gov/data/search?f%5B0%5D=field_report_type%3AWorld%20Production%2C%20Markets%2C%20and%20Trade%20Reports. Accessed 28 Oct 2018

  7. Grand View Research (2017) Biotechnology market analysis by application (Health, food & agriculture, natural resources & environment, industrial processing bioinformatics), by technology, and segment forecasts, 2018–2025. Report ID: 978-1-68038-134-4. https://www.grandviewresearch.com/industry-analysis/biotechnology-market. Accessed 28 Oct 2018

  8. Green ED, Rubin EM, Olson MV (2017) The future of DNA sequencing. Nature news. Oct 11, 2017. https://www.nature.com/news/the-future-of-dna-sequencing-1.22787#/ref-link-5. Accessed 28 Oct 2018

  9. NGSRI (2013) National Human Genome Research Institute. http://www.genome.gov/11006943. Accessed 28 Oct 2018

  10. Paxton A (2017) Cell-free DNA screening blooms in expansion to low-risk pregnancies. CAP Today (College of American Pathologists) March 2017. http://captodayonline.com/cell-free-dna-screening-blooms-expansion-low-risk-pregnancies/. Accessed 28 Oct 2018

  11. SAM (2017) Scientific Advice Mechanism of the EC. New techniques in agricultural biotechnology, explanatory note Feb 2017. https://ec.europa.eu/research/sam/pdf/topics/explanatory_note_new_techniques_agricultural_biotechnology.pdf. Accessed 28 Oct 2018

  12. Whelan AI, Lema MA (2015) Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina. GM Crops Food 6:253–265

    Article  PubMed Central  PubMed  Google Scholar 

Download references

Acknowledgements

The Institute of Biological, Environmental and Rural Sciences (IBERS) receives strategic funding from the Biotechnology and Biological Sciences Research Council (BBSRC) via Grant [BB/CSP1730/1].

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Correspondence to Huw D. Jones.

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Jones, H.D. Future-proofing regulation for rapidly changing biotechnologies. Transgenic Res 28, 107–110 (2019). https://doi.org/10.1007/s11248-019-00143-4

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