Herbal Medicinal Products: The Need for Regulation

Herbal medicines have been used extensively to treat a broad range of medical conditions. Recent years have witnessed an increase in their use, but questions remain concerning their quality, safety and efficacy (QSE). From a quality point of view, there must be an assurance that the herbal product is what it claims to be. It may be more difficult to characterise a herbal product – usually a variable and complex mixture of chemical components – than a conventional pharmaceutical drug. With respect to safety, the potential side effects, as well as any possible interactions with other drugs, must be fully understood. Finally, it is important to establish the efficacy of the herbal medicine when used to treat a given condition. Equipped with this knowledge, it becomes easier to identify how herbal medicines can be used with minimal adverse effects on the patient. Selected regulatory agencies in Europe and the US have already implemented measures to accommodate the requirements for establishing the QSE of herbal medicinal products, distinct from QSE requirements for conventional pharmaceutical drugs.

Herbal medicines have been developed and used by man for thousands of years (1). Plants have formed the basis of sophisticated traditional medicine systems, among which are Ayurvedic (2), Arabic (3) and Chinese (4). Many of the pharmaceuticals available to Western physicians today have a long history of use as herbal remedies, such as opium, aspirin, digitalis and quinine.

The use of herbs to treat disease is almost universal among nonindustrialised societies. In developing countries, as much as 80 per cent of the indigenous populations depend on medicinal plants and traditional systems of medicine as their primary source of healthcare. Within the European Community, herbal medicines account for an important share of the pharmaceutical market, with annual sales in the range of US$7 billion. In the US alone, the sale of herbal medicines exceeded $3.3 billion in 1997 (5). The accurate scientific assessment of herbal medicine is a prerequisite for global harmonisation of herbal health claims. In a recent World Health Organization (WHO) report (6), the following was highlighted: