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~ Regulatory Status of Herbal Medicine Worldwide

The World Health Organization (WHO) estimates that 4 billion people--80 percent of the world population--use herbal medicine for some aspect of primary health care (Farnsworth et al., 1985). Herbal medicine is a major component in all indigenous peoples' traditional medicine and is a common element in Ayurvedic, homeopathic, naturopathic, traditional oriental, and Native American Indian medicine (see the "Alternative Systems of Medical Practice" chapter).

The sophistication of herbal remedies used around the world varies with the technological advancement of countries that produce and use them. These remedies range from medicinal teas and crude tablets used in traditional medicine to concentrated, standardized extracts produced in modern pharmaceutical facilities and used in modern medical systems under a physician's supervision.

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Europe~Drug approval considerations for phytomedicines (medicines from plants) in Europe are the same as those for new drugs in the United States, where drugs are documented for safety, effectiveness, and quality. But two features of European drug regulation make that market more hospitable to natural remedies. First, in Europe it costs less and takes less time to approve medicines as safe and effective. This is especially true of substances that have a long history of use and can be approved under the "doctrine of reasonable certainty." According to this principle, once a remedy is shown to be safe, regulatory officials use a standard of evidence to decide with reasonable certainty that the drug will be effective. This procedure dramatically reduces the cost of approving drugs without compromising safety. Second, Europeans have no inherent prejudice against molecularly complex plant substances; rather, they regard them as single substances.

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The European Economic Community (EEC), recognizing the need to standardize approval of herbal medicines, developed a series of guidelines, The Quality of Herbal Remedies (EEC Directive, undated). These guidelines outline standards for quality, quantity, and production of herbal remedies and provide labeling requirements that member countries must meet. The ~EEC guidelines are based on the principles of the WHO's Guidelines for the Assessment of Herbal Medicines (1991). According to these guidelines, a substance's historical use is a valid way to document safety and efficacy in the absence of scientific evidence to the contrary. (App. C contains the complete WHO guidelines.) The guidelines suggest the following as a basis for determining product safety:

A guiding principle should be that if the product has been traditionally used without demonstrated harm, no specific restrictive regulatory action should be undertaken unless new evidence demands a revised risk-benefit assessment. . . . Prolonged and apparently uneventful use of a substance usually offers testimony of its safety.

With regard to efficacy, the guidelines state the following:

For treatment of minor disorders and for nonspecific indications, some relaxation is justified in the requirements for proof of efficacy, taking into account the extent of traditional use; the same considerations may apply to prophylactic use (WHO, 1991).~The WHO guidelines give further advice for basing approval on existing monographs:

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If a pharmacopoeia monograph exists it should be sufficient to make reference to this monograph. If no such monograph is available, a monograph must be supplied and should be set out in the same way as in an official pharmacopoeia.

To further the standardization effort and to increase European scientific support, the phytotherapy societies of Belgium, France, Germany, Switzerland, and the United Kingdom founded the European Societies' Cooperative of Phytotherapy (ESCOP). ESCOP's approach to eliminating problems of differing quality and therapeutic use within EEC is to build on the German scientific monograph system (below) to create "European" monographs.

In Europe, herbal remedies fall into three categories. The most rigorously controlled are prescription drugs, which include injectable forms of phytomedicines and those used to treat life-threatening diseases. The second category is OTC phytomedicines, similar to American ~OTC drugs. The third category is traditional herbal remedies, products that typically have not undergone extensive clinical testing but are judged safe on the basis of generations of use without serious incident.

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The following brief overviews of phytomedicine's regulatory status in France, Germany, and England are representative of the regulatory status of herbal medicine in Europe.

France, where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. These products are distinguished from approved pharmaceutical drugs by labels stating "Traditionally used for . . ." Consumers understand this to mean that indications are based on historical evidence and have not necessarily been confirmed by modern scientific experimentation (Artiges, 1991).

Germany considers whole herbal products as a single active ingredient; this makes it simpler to define and approve the product. The German Federal Health Office regulates such ~products as ginkgo and milk thistle extracts by using a monograph system that results in products whose potency and manufacturing processes are standardized. The monographs are compiled from scientific literature on a particular herb in a single report and are produced under the auspices of the Ministry of Health Committee for Herbal Remedies (Kommission E). Approval of such remedies requires more scientific documentation than traditional remedies, but less than new pharmaceutical drug approvals (Keller, 1991).

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In Germany there is a further distinction between "prescription-only drugs" and "normal prescription drugs." The former are available only by prescription. The latter are covered by national health insurance if prescribed by a physician, but they can be purchased over the counter without a prescription if consumers want to pay the cost themselves (Keller, 1991). OTC phytomedicines--used for self-diagnosed, self-limiting conditions such as the common cold, or for simple symptomatic relief of chronic conditions--are not covered by the national health insurance plan.

England generally follows the rule of prior use, which says that hundreds of years of use with ~apparent positive effects and no evidence of detrimental side effects are enough evidence--in lieu of other scientific data--that the product is safe. To promote the safe use of herbal remedies, the Ministry of Agriculture, Fisheries, and Food and the Department of Health jointly established a database of adverse effects of nonconventional medicines at the National Poisons Unit.

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Asia

In more developed Asian countries such as Japan, China, and India, "patent" herbal remedies are composed of dried and powdered whole herbs or herb extracts in liquid or tablet form. Liquid herb extracts are used directly in the form of medicinal syrups, tinctures, cordials, and wines.

In China, traditional herbal remedies are still the backbone of medicine. Use varies with region, but most herbs are available throughout China. Until 1984 there was virtually no regulation of pharmaceuticals or herbal preparations. In 1984, the People's Republic ~implemented the Drug Administration Law, which said that traditional herbal preparations were generally considered "old drugs" and, except for new uses, were exempt from testing for efficacy or side effects. The Chinese Ministry of Public Health would oversee the administration of new herbal products (Gilhooley, 1989).

Traditional Japanese medicine, called kampo, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese folklore. Kampo declined when Western medicine was introduced between 1868 and 1912, but by 1928 it had begun to revive. Today 42.7 percent of Japan's Western-trained medical practitioners prescribe kampo medicines (Tsumura, 1991), and Japanese national health insurance pays for these medicines. In 1988, the Japanese herbal medicine industry established regulations to manufacture and control the quality of extract products in kampo medicine. Those regulations comply with the Japanese government's Regulations for Manufacturing Control and Quality Control of Drugs.

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Developing Countries~Herbal medicines are the staple of medical treatment in many developing countries. Herbal preparations are used for virtually all minor ailments. Visits to Western-trained doctors or prescription pharmacists are reserved for life-threatening or hard-to-treat disorders.

Individual herbal medicines in developing regions vary considerably; healers in each region have learned over centuries which local herbs have medicinal worth. Although trade brings a few important herbs from other regions, these healers rely mainly on indigenous herbs. Some have extensive herbal materia medica. A few regions, such as Southeast Asia, import large amounts of Chinese herbal preparations. But the method and form of herb use are common to developing regions.

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In the developing world, herbs used for medicinal purposes are "crude drugs." These are unprocessed herbs--plants or plant parts, dried and used in whole or cut form. Herbs are prepared as teas (sometimes as pills or capsules) for internal use and as salves and poultices for external use. Most developing countries have minimal regulation and oversight.

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