Department of Botany and Plant Biotechnology, University of Johannesburg, Johannesburg, South Africa.
Traditional Medicinals Inc., Rohnert Park CA, United States.
Curr Neuropharmacol. 2021;19(9):1384-1400. doi: 10.2174/1570159X19666210215124737.
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.
现代监管系统管理着健康产品进入国家市场的条件，这在国际层面上构成了传统草药进入市场的障碍。监管意图侧重于确保消费者获得安全、有效和高质量的产品，但这也限制了传统草药产品的机会，特别是那些在各自的国家市场中没有长期使用传统的产品。本案例研究调查并比较了一种具有很大作为抗焦虑和轻度抗抑郁作用的南非草药——扭蒴苣苔（Mesembryanthemum tortuosum L. [syn. Sceletium tortuosum (L.) N.E.Br.] 地上部分）——在当今监管环境下的国际情况。有人认为，监管上的无意偏袒加上缺乏充分保护知识产权的手段，可能会通过为成功开发产品和将发展中国家的植物药引入世界上大多数健康产品市场设置几乎不可逾越的经济障碍来阻碍创新。
