Regulatory Frameworks for Biopesticides and Biostimulants: A Comparative Analysis of the EU, US, India and Japan

Dr. Abhijit A. Pujari

Volume 7, Issue 4 2023

Page: 12-17

Abstract

In the EU, the last months have seen significant changes in regard to the current as well as the future regulations for biopesticides and biostimulants. One of the key issues of course is the step from national biostimulant regulations to EU harmonised rules under a fertiliser framework. Entry into force of the new EU fertiliser Regulation 2019/1009 has brought on several changes. For one, the new regulation will significantly simplify market entry for biostimulant products from its applicability in 2022 onwards, provided that they are compliant to the new regulation, as there will be harmonised rules and procedures applicable for all EU Member States. However, by including biostimulant products and explicitly excluding them from EU plant protection products Regulation 1107/2009, the new fertiliser regulation not only closes a regulatory gap through bringing biostimulants under harmonised rules from June 2022 onwards, but opens up another one. This is mainly due to the fact that the official definition of biostimulants, eligible for registration under the EU framework in future, is mainly a legal and regulatory, not a scientific one. According to Regulation 2019/1009 biostimulants are defined as products ‘stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: (a) nutrient use efficiency, (b) tolerance to abiotic stress, (c) quality traits, [or] d) availability of confined nutrients in soil or rhizosphere’. However, plants normally do not adhere to regulatory definition and thus do not differentiate between abiotic and biotic stress

Back Download



References

  • European Commission (2018) A sustainable bioeconomy for Europe: strengthening the connection between economy, society and the environment.
  • German Bioeconomy Council (2015) Bioeconomy policy (Part I) Synopsis and analysis of Strategies in the G7.
  • Ostrom E (2009) A general framework for analyzing sustainability of social-ecological systems. Science 325(5939):419.
  • Aaken AV (2008) Effectuating public international law through market mechanisms? Comparative Research in Law & Economy, Research Paper 34/2008, 04(07)
  • Abbott F (2017) Excessive pharmaceutical prices and competition law: doctrinal development to protect public health. UC Irvine Law Rev 6(3)
  • Ashford N, Hall R (2011) The importance of regulation-induced innovation for sustainable development. Sustainability:270–292
  • Cadillo Chandler D (2016) The never ending story of access to medicines. WIPO J: Anal Intellect Prop 8(1):42–51
  • Capp DA (2003) A Propiedade Intelectual Na Constitução. In: Fabris S (ed) Límites Jurídicos da Regulação e Defensa da Concorrência (p.52). Porto Alegre
  • Curley D, Horst MH (2012) Patents and regulatory data exclusivity for medicinal products. In: Wilkof N, Basheer S (eds) Overlapping intellectual property rights. Oxford University Press, Oxford, pp119–136
  • EXPH– Expert Panel on Effective Ways to Investing in Health (2018) Opinion on Innovative payment models for high-cost innovative medicines. Publications Office of the European Union, Luxemburg
  • Grosse Ruse-Khan H (2010) Sustainable development in international intellectual property law– new approaches from EU economic partnership agreements? ICTSD programme on IPRs and sustainable development (Paper N 29)
  • Kremer M (2002) Pharmaceuticals and the developing world. J Econ Perspect 16(4):67–90Love J, Hubbard T (2007) The big idea: prizes to stimulate R&D for new medicines. Chicago Kent Law Rev 82(3):1519– 1554.
  • Manley M i, Vickers M (2015) Supplementary protection certicates. In: Manley M i, Vickers M (eds) Navigating European pharmaceutical law. Oxford University Press, Oxford, pp 277–299.
  • Mejer M (2017) 25 years of SPC protection for medicinal products in Europe: insights and challenges.

Looking for Paper Publication??

Come to us.