HERBS AND PHYTOMEDICINES IN THE EUROPEAN COMMUNITY
In Western Europe, the professional use of herbs and phytomedicines enjoys relatively strong integration with conventional medicine. In the countries of the European Union (formerly European Economic Community, EEC), herbal medicines are generally sold in pharmacies as licensed nonprescription or prescription medicines. According to EU directive 65/65/EEC, all phytomedicines are treated as drugs. Registrations based on quality, safety, and efficacy are required (Keller, 1994; Schilcher, 1991). Exceptions include the Netherlands and the United Kingdom, where botanicals are still sold as food supplements or dietary supplements (Gruenwald, 1998).
According to European Union definitions, herbal medicinal products (medicines) are "medicinal products containing as active ingredients exclusively plant material and/or vegetable drug preparations." Vegetable drugs are "plant material used for a medicinal purpose. An herbal drug or a preparation thereof is regarded as one active ingredient in its entirety whether or not the constituents with therapeutic activity are known." Herbal medicinal preparations are "comminuted or powdered vegetable drugs, extracts, tinctures, fatty or essential oils, expressed plant juices, etc. prepared from herbal drugs, and preparations whose production involves a purification or concentration process. However, chemically defined isolated constituents or their mixtures are not considered herbal medicinal products. Other substances such as solvents, diluents, preservatives [or] may form part of vegetable drug preparations. These substances must be indicated." Constituents with known therapeutic activity "are chemically defined substances or groups of substances which are known to contribute to the therapeutic activity of a vegetable drug or of a preparation." (Commission of European Communities, 1989.) (This definition formerly contained the term "vegetable drug" when first published; .however, this term was replaced by "herbal medicinal product" by EU in November 1997 [Busse, 1997c]). Some scientists consider isolated plant substances used as conventional drugs in pharmacy and medicine (e.g., digitoxin, atropine, escin, etc.) as phytomedicines, but these are not regulated as phytomedicines under German or EU drug laws (Schilcher, 1997b). Table 3: Sales of OTC Herbal Remedies in the Euronean Union - 1996
Estimation based on Institute for Medical Statistics (IMS) market analysis of 1994 plus average growth rates. Source: PhytoPharm Consulting Berlin (Gruenwald 1998).
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