Regulatory Approval Asynchrony, LLP, and Implications for Biotech R&D and Innovation

Abstract

Progress toward sustainable and profitable farming systems using a full technology toolbox is needed to accelerate agricultural productivity globally. Increasing agricultural productivity is one of the keys to ensuring global food security. Food security is a serious issue for many countries that are dependent on commodity markets to meet their needs or supplement domestic agricultural productivity. High dependence on imports places countries at risk of production shortfalls, supply constraints, and price volatility due to growing global demand and competition for grain commodities. Prolonged regulatory timelines due to asynchronous approvals coupled with a lack of harmonized policies on low-level presence of unapproved events contribute to uncertainty that directly impacts product launches and indirectly affects the pace of research, development, commercialization, and import of innovative products. The public and private sector technology pipelines are producing new discoveries and developing innovations that promise to increase the pace of crop genetic improvement. While the opportunities for delivering more productive, pest resistant crops that use less water and inputs per unit production are real, success will depend on establishing efficient, predictable, and rational evidence-based regulatory frameworks.