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Off-Patent Transgenic Events: Challenges and Opportunities for New Actors and Markets in Agriculture

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      Abstract

      More than 20 years ago, the first genetically modified (GM) plants entered the seed market. The patents covering the first GM plants have begun to expire and these can now be considered as Off-Patent Events. Here we describe the challenges that will be faced by a Secondary Party by further use and development of these Off-Patent Events. Indeed, the conditions for Off-Patent Events are not available yet to form the basis for a new viable industry similar to the generic manufacturers of agrochemicals or pharmaceutical products, primarily because of (i) unharmonized global regulatory requirements for GM organisms, (ii) inaccessibility of regulatory submissions and data, and (iii) potential difficulties to obtain seeds and genetic material of the unique genotypes used to generate regulatory data. We propose certain adaptations by comparing what has been done in the agrochemical and pharmaceutical markets to facilitate the development of generics. Finally, we present opportunities that still exist for further development of Off-Patent Events in collaboration with Proprietary Regulatory Property Holders in emerging markets, provided (i) various countries approve these events without additional regulatory burdens (i.e., acceptance of the concept of data transportability), and (ii) local breeders agree to meet product stewardship requirements.

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      A chimaeric antibiotic resistance gene as a selectable marker for plant cell transformation

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        Expression of chimaeric genes transferred into plant cells using a Ti-plasmid-derived vector

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          Definition and Classification of Generic Drugs Across the World

          Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30 % of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.
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            Author and article information

            Affiliations
            1Perseus BVBA , Sint-Martens-Latem, Belgium
            2Association Française des Biotechnologies Végétales , Paris, France
            3Bio-EZ , Saint Cyr au Mont d'Or, France
            4Department of Plant Biotechnology and Bioinformatics, Ghent University , Gent, Belgium
            5International Plant Biotechnology Outreach, Vlaams Instituut voor Biotechnologie (VIB) , Gent, Belgium
            Author notes

            Edited by: Karen Hokanson, University of Minnesota Twin Cities, United States

            Reviewed by: Gerald Epstein, U.S. Department of Homeland Security, United States; Zohre Kurt, Middle East Technical University, Turkey

            *Correspondence: Marc Heijde marc.heijde@ 123456vib-ugent.be

            †Present Address: Ine Pertry, Inagro, Roeselare, Belgium

            This article was submitted to Biosafety and Biosecurity, a section of the journal Frontiers in Bioengineering and Biotechnology

            Contributors
            Journal
            Front Bioeng Biotechnol
            Front Bioeng Biotechnol
            Front. Bioeng. Biotechnol.
            Frontiers in Bioengineering and Biotechnology
            Frontiers Media S.A.
            2296-4185
            04 June 2018
            2018
            : 6
            5994546
            10.3389/fbioe.2018.00071
            Copyright © 2018 Rüdelsheim, Dumont, Freyssinet, Pertry and Heijde.

            This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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            Figures: 0, Tables: 0, Equations: 0, References: 18, Pages: 8, Words: 6292
            Categories
            Bioengineering and Biotechnology
            Policy and Practice Reviews

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