PDF(Pubmed)
Abstract：
The regulation and use of herbal medicines is a topic of debate due to concerns about their quality, safety, and efficacy. EU Directive 2004/24/EC on Herbal Medicinal Products was a significant step towards establishing a regulatory framework for herbal medicinal products in the EU, and bridging the gap between conventional and herbal medicines. This Directive allows herbal medicinal products to be marketed in the EU through full marketing authorisation, well-established use, and traditional use of herbal medicinal products. The framework relies on the correlation between the therapeutic claims of herbal medicine and the scientific evidence backing them up: the greater the claims made regarding medicinal benefits, the more evidence is required to substantiate its efficacy and safety. This regulatory framework acknowledges and incorporates traditional knowledge when evaluating herbal medicines, showcasing a balanced approach that values cultural traditions while mandating monographs for traditional herbal medicinal products. Excluding herbal medicines completely limits access to affordable treatment, particularly when they serve as the only alternative for some, and protects consumer autonomy. This EU framework could therefore serve as a practical guidance for the use and regulation of herbal medicines, even outside the EU. In conclusion, it is argued that the same moral imagination and courage shown by regulators in the case of herbal medicines could perhaps be used in the regulatory frameworks of other healthcare products.
摘要：
由于对草药质量的担忧，草药的监管和使用是一个争论的话题，安全,和功效。欧盟关于草药产品的指令2004/24/EC是在欧盟建立草药产品监管框架的重要一步，弥合传统药物和草药之间的差距。该指令允许草药产品通过完整的营销授权在欧盟销售，良好的使用，和传统的草药产品的使用。该框架依赖于草药的治疗主张与支持它们的科学证据之间的相关性：关于药用益处的主张越大，需要更多的证据来证实其有效性和安全性。该监管框架在评估草药时承认并纳入传统知识，展示了一种平衡的方法，即重视文化传统，同时强制要求传统草药产品的专着。排除草药完全限制了人们获得负担得起的治疗，尤其是当它们作为某些人的唯一选择时，保护消费者自主权。因此，这一欧盟框架可以作为草药使用和监管的实际指导，甚至在欧盟之外。总之,有人认为，监管机构在草药方面表现出的同样的道德想象力和勇气也许可以用于其他医疗保健产品的监管框架。
