Comparative Analysis of the Regulations for the Marketing and Quality Control of Herbal Products Used for Health in France, Peru and West Africa

Abstract

Traditional medicine is increasingly promoted worldwide as a tool to achieve universal access to healthcare. Herbal medicines have formed the basis of healthcare throughout the world and are still widely used, playing a major role in the international health market. However, several factors influence the potential quality of phytotherapy. The diversity of herbal medicines, their various uses and preparation methods, the pluralism in access to these treatments, and the variability in the chemical composition of raw materials depending on their environment are all critical elements. This study compares the regulatory frameworks and quality control practices for plant-based health products in six countries: Benin, Burkina Faso, Guinea, Mali, Peru and France. It also provides an overview of the market in these countries. To do so, we compiled and highlighted key information from WHO guidelines, national legal documents, public databases on product registration and markets, and conducted interviews with health organisation experts. The main findings indicate that West African countries face challenges related to regulatory enforcement and limited industrial and research capacity. In contrast, Peru experienced an initial surge in production following regulation in 1997 and gained international recognition for Amazonian plants, but saw a decline after the 2009 U.S.-Peru Free Trade Agreement due to more stringent standards. France, while notable for its pharmacopoeia, struggles to implement quality control given the high volume of dietary supplements available. Based on these comparative insights, the paper recommends a multidimensional approach: promoting stakeholder training in good practices, developing robust pharmacopoeias, facilitating dialogue between traditional and allopathic medicines, and building shared infrastructures for research and quality control. These strategies, informed by successful practices across countries, aim to support the safe and equitable development of herbal health products worldwide.