Thomas Brendler*, Josef A. Brinckmann, Ulrich Feiter, Nigel Gericke, Lucy Lang, Olga N. Pozharitskaya, Alexander N. Shikov, Michael Smith and Ben-Erik Van Wyk Pages 1384 - 1400 ( 17 )
Modern-day regulatory systems governing conditions for how health products enter national markets constitute a barrier of access for traditional herbal medicines on an international level. Regulatory intentions are focused on ensuring that consumers are being provided with safe, efficacious and high-quality products that, however, collaterally limit opportunities for traditional herbal medicinal products, especially those that do not already have a long-standing tradition of use established in the respective national marketplaces. This case study investigates and compares how a Southern African herbal medicine with great potential as an anxiolytic and mild antidepressant - Mesembryanthemum tortuosum L. [syn. Sceletium tortuosum (L.) N.E.Br.] aerial parts - fares internationally in today’s regulatory environments. It is argued that inadvertent regulatory favoritism combined with the lack of means for adequate protection of intellectual property may obstruct innovation by creating an almost insurmountable economical hurdle for successful product development and introduction of botanicals from developing countries into most of the world’s health product markets.
Mesembryanthemum tortuosum, sceletium, anxiety, depression, regulations.
Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, Traditional Medicinals Inc., Rohnert Park CA, Parceval (Pty) Ltd., Wellington, Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, Complementary Medicines Australia, PO Box 450 Mawson ACT 2607, Murmansk Marine Biological Institute of the Russian Academy of Sciences (MMBI RAS), Murmansk, Saint-Petersburg State Chemical Pharmaceutical University, 14a, Prof. Popov, Saint-Petersburg, National Center for Natural Products Research, University of Mississippi, Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg