The Commission E Monographs |
THE COMPLETE GERMAN COMMISSION E MONOGRAPHS
THERAPEUTIC GUIDE TO HERBAL MEDICINES
Copyright © 1999 American Botanical Council
Part One Introduction
<< Previous | Table Of Contents | Next >>
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 European Union - 1996
||Annual Retail Sales
in millions (US $)
Therapeutic Categories of Phytomedicine Sales in the European Union
|Source: Gruenwald, 1995.
Cooperative on Phytotherapy (ESCOP)
The European market for herbs and phytomedicines is characterized by the
availability of a fairly large number of products. A report conducted in 1991 of
the Member States (nations) indicated that about 1,400 herbal drugs were
available in the EEC. When this study focused on herbs used in five of the 10
Member States, 145 herbal drugs were noted (Keller, 1996). According to Dr.
Konstantin Keller of the German Federal Institute for Drugs and Medical Devices
(BfArM), "this shows that herbal drugs are indeed a major problem for
harmonization in the EU." (Keller, 1996).
One important initiative in the development of herbal monographs in Western
Europe is ESCOP (European Scientific Cooperative on Phytotherapy), an
affiliation of 15 national associations of phytotherapy, mostly from Western
Europe, that formed in 1989 as a result of the European harmonization process.
Since June 1997 ESCOP has produced a series of 50 herbal monographs to respond
to the increasing integration of the European Union (EU). The need for
harmonized drug monographs for herbs was recognized so that there could be
standards for botanicals popularly used in medicine and pharmacy in Europe.
The ESCOP monographs were published in volumes ("fascicules") of 10
monographs each. They were published in the form of standardized drug dossiers
of European drug licensing, known as specific product characteristics (SPCs).
Unlike a pharmacopeial monograph that focuses on standards for identity and
quality, ESCOP monographs, like those of Commission E, deal with therapeutic
aspects of each phytomedicine. Thus, ESCOP monographs include approved
therapeutic uses and contain the format much like recent Commission E
monographs, including recommended dosage, side effects and contraindications (if
any), and other specific instructions for health professionals, industry,
regulators, and patients (Blumenthal, 1997).
ESCOP monographs do not deal directly with qualitative standards for herbal
drugs; this area is covered in other pharmacopeial monographs. For example, the
European Pharmacopoeia includes 60 monographs on herbal drugs. An additional 45
draft monographs have been published for comments. According to Keller,
"This cooperative approach will greatly facilitate harmonization of herbal
remedies." (Keller, 1996).
<< Previous | Table Of Contents | Next >>