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Review
. 2020 Apr 15:8:303.
doi: 10.3389/fbioe.2020.00303. eCollection 2020.

Gene Editing Regulation and Innovation Economics

Agustina I Whelan  1   2 , Patricia Gutti  1   3 , Martin A Lema  2   3
Affiliations
Review

Gene Editing Regulation and Innovation Economics

Agustina I Whelan et al. Front Bioeng Biotechnol. .

Abstract

Argentina was the first country that enacted regulatory criteria to assess if organisms resulting from new breeding techniques (NBTs) are to be regarded as genetically modified organisms (GMOs) or not. The country has now accumulated 4 year of experience applying such criteria, reaching a considerable number of cases, composed mostly of gene-edited plants, animals, and microorganisms of agricultural use. This article explores the effects on economic innovation of such regulatory experience. This is done by comparing the cases of products derived from gene editing and other NBTs that have been presented to the regulatory system, against the cases of GMOs that have been deregulated in the country. Albeit preliminary, this analysis suggests that products from gene editing will have different profiles and market release rates compared with the first wave of products from the so called "modern biotechnology." Gene editing products seems to follow a much faster development rate from bench to market. Such development is driven by a more diverse group of developers, and led mostly by small and medium enterprises (SMEs) and public research institutions. In addition, product profiles are also more diversified in terms of traits and organisms. The inferences of these findings for the agricultural and biotechnology sectors, particularly in developing countries, are discussed.

Keywords: CRISPR-CAS; bioeconomy; biotechnology indicators; biotechnology regulation; gene editing; genome editing; innovation economy; new breeding techniques.

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Figures

FIGURE 1
FIGURE 1
The timeline of GMO approvals in Argentina and the determination of conventional or GMO status for products obtained using different NBTs. The horizontal axis represents the year of the regulatory decision, and the vertical axis represents the number of products. See text for details.
FIGURE 2
FIGURE 2
GMO products by developer profiles. See text for details.
FIGURE 3
FIGURE 3
NBT (non-GMO) products by developer profiles. See text for details.
FIGURE 4
FIGURE 4
Numbers of each type of developers of GMOs approved. See text for details.
FIGURE 5
FIGURE 5
Numbers of each type of developers of NBT (non-GMO) products. See text for details.
FIGURE 6
FIGURE 6
Introduced traits in GMO products. See text for details.
FIGURE 7
FIGURE 7
Introduced traits in NBT (non-GMO) products. See text for details.
FIGURE 8
FIGURE 8
Approved GMOs distributed by type of organism. See text for details.
FIGURE 9
FIGURE 9
NBT (non-GMO) products distributed by type of organism. See text for details.
FIGURE 10
FIGURE 10
Distribution of NBT (non-GMO) products, classified by state of development. See text for details.
FIGURE 11
FIGURE 11
Usage of Gene-editing within NBTs. See text for details.
See this image and copyright information in PMC

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