**5.2. An alternative approach to healthcare**

Plants are perceived to be healthier than conventional biosynthetic drugs. Reports on conventional drugs adverse effects has been found to be much higher compared to herbal toxicity reports [4]. Other reasons for the use of herbal medicine include: (i) several claims on the efficacy and safety of plant medicines [11], (ii) improvements in the quality of herbal medicines with the development of scientific evaluation [21], (iii) to relieve symptoms related to chronic or terminal illnesses [37], such as HIV/AIDS, malaria, diabetes and sickle-cell anemia [38]. A survey conducted in the USA showed that 78% of patients living with HIV/AIDS use some form of herbal medicine. In such cases, western medicine is perceived to have failed the public [4].

**6.4. Need for scientific and clinical evaluation of herbal medicine**

follow these guidelines to validate herbal products [1].

**7. National policies of herbal medicine**

cerning their products are precise [39, 44].

The concern surrounding safety of herbal medicinal products is increasing [8]. In order to allay these concerns and achieve public reliance on herbal medicine, manufacturers, researchers and regulatory authorities must follow inclusive clinical trials and vigorous scientific methodologies to ensure the quality and safety of herbal products [41]. The safety evaluation of any herbal drug considers two important factors; the nature and significance of the adversarial effect. Toxicity screening can disclose some of the risks related to the use of herbal medicine [43]. In 1991, WHO issued guidelines for the assessment of herbal medicine which include: (i) Quality assessment: crude plant material; plant preparation; finished product. (ii) Stability: shelf life. (iii) Safety assessment: documentation of safety based on experience or toxicology studies. (iv) Assessment of efficacy: documented evidence of traditional use or activity determination (animals, human) [6].The US Food and Drug Administration (FDA), the International Conference on Harmonization (ICH) and the United States Pharmacopeia (USPC, 1994–2001)

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A national policy on herbal medicine may include the following: a defining role of herbal medicine in the health care system, provision for the necessary regulations and laws, contemplation of intellectual property concerns [22]. National policies vary from country to country regarding herbal medicine. Herbal medicines are classified as either prescription or non-prescription medicines. The Working Party on Natural and Nutritional Supplements was established by the Australian Parliament to evaluate the safety, efficacy, quality and labeling of herbal products (Therapeutic Good Act, 1990). The act states "that traditional claims for herbal remedies be allowed, providing general advertising requirements are complied with and providing such claims are justified by literature references" [11]. Herbal medicine in Canada must meet the terms of the National Health Products Regulations. In accordance to these regulations, a product license is required for all herbal products to be sold in Canada. The recommended use, potency, comprehensive information on the medicinal constituents, source and nonmedicinal constituents need to be provided in order for a license to be granted. The companies that manufacture, pack, label and import herbal medicine also need a site license [3].

The Dietary Supplement Health and Education Act (DSHEA) of 1994, states that any herb, natural and botanical concentrate, constituent and metabolite of extract, is categorized as a dietary supplement. These supplementations do not need any sanction from the FDA. Herbal medicine which is categorized as dietary supplements under DSHEA, are alleged to be safe and the FDA does not have the authority to require them to be approved for efficacy and safety before they enter the market. However, manufacturers of these herbal products are required to provide purity and identification standards, and confirm that claims made con-

In Chile the Unidad de Medicina Tradicional was established in 1992, with the aim of incorporating herbal medicine with established efficacy into health programs (Law No. 19.253,
