German E Commission
The German E Commission monographs represent the most accurate information available in the world today on the safety and efficacy of herbs and phytomedicines.
The therapeutic use of herbs and herb-based medicines (phytomedicines) has always been very popular in Germany. About 70 percent of the physicians in general practice prescribe herbal remedies, a significant portion of which is paid for by government health insurance. Because of the wide use of herbal remedies, which includes essential oils, the German government developed a way to assure product standardization and safe use.
In 1976, the Federal Republic of Germany began defining herbal remedies in the same manner as other drugs. Two years later, the “Commission E” was established, an expert committee of physicians, pharmacists, pharmacologists, toxicologists, representatives of the pharmaceutical industry and lay persons, to evaluate the safety and efficacy of phytomedicines.
The Commission E checks bibliographic and research data on each phytomedicine independent of the manufacturer. Such data includes information obtained from clinical trials, field studies, collections of single cases, scientific literature including facts published in the standard reference works, and expertise of medical associations. This process leads to the establishment of “reasonable certainty” of the uses and safety of the herb being evaluated. See Note below.
After completing its research into an herb, the Commission E prepares a draft monograph regarding the herb's suitability for medicinal use, allows a period for comments, then publishes the monograph in the German equivalent of the Federal Register. The monographs normally include nomenclature, plant part used, chemical constituents, range of application, contraindications, side effects, incompatibilities with other medications, dosage, use, and action of the herb.
By 1993, approximately 380 monographs had been prepared and published on individual herbs. 254 herbs were approved for medicinal use. The remaining 126 of the herbs researched were found to be ineffective or risky.
Note
It is important to note that
"reasonable certainty" is not the same as U.S. Federal Drug
Administration requirements, which involve "absolute certainty" of the
efficacy of a new drug based on clinical trials. This FDA requirement costs on
the average of $350 million per new drug. The drug is patented by the
manufacturer, who can recover their research costs in sales profits. Patent
protection for herbs is not usually available, so high research costs are not
recoverable by the herb manufacturer. This is a significant reason why herbs do
not have drug status in the U.S.
Before herbs can be approved as medicines by the FDA, a different mechanism of assuring safety and efficacy will need to be created in the U.S. that is appropriate and economically feasible. The German model has shown us that "reasonable certainty" of safety and efficacy is adequate for well-known herbal remedies.