Over many centuries, the safety and limitations of herbal medicines have been established by
their empirical use by the “healers” who also took a holistic approach. The “healers” are aware of
the infrequent adverse effects and know how to correct these when they occur. Consequently and
ideally, the pre-clinical and clinical studies of a herbal medicine need to be carried out with the
full cooperation of the traditional healer. The plant composition of the medicine, the stage of the
development of the plant material, when it is to be collected from the wild or when from cultivation,
its post-harvest treatment, the preparation of the medicine, the dosage and frequency, and much
other essential information is required. A consideration of the intellectual property rights and
appropriate models of benefit sharing may also be necessary