To establish efficacy of treatment for a named specific disease by herbs, the DHSS requires scientific data presented to the Regulatory authorities for consideration and approval.
A product is not considered a herbal remedy if its active principle(s) have been isolated and concentrated, as in the case of digitalis from the Foxglove. (MAL 2. Guidance notes)
A herbal product is one in which all active ingredients are of herbal origin. Products that contain both herbal and non-vegetable substances are not considered herbal remedies: i.e. Yellow Dock combined with Potassium Iodide.
The British Government supports freedom of the individual to make an informed choice of the type of therapy he or she wishes to use and has affirmed its policy not to restrict the general availability of herbal remedies. Provided products are safe and are not promoted by exaggerated claims, the future of herbal products is not at risk. A doctor with knowledge and experience of herbal medicine may prescribe them if he considers that they are a necessary part of treatment for his patient.
Herbalism is aimed at gently activating the body’s defence mechanisms so as to enable it to heal itself. There is a strong emphasis on preventative treatment. In the main, herbal remedies are used to relieve symptoms of self-limiting conditions. They are usually regarded as safe, effective, well-tolerated and with no toxicity from normal use. Some herbal medicines are not advised for children under 12 years except as advised by a manufacturer on a label or under the supervision of a qualified practitioner.
World Health Organisation Guidelines
The assessment of Herbal Medicines are regarded as:–
Finished, labelled medicinal products that contain as active ingredients aerial or underground parts of plants, or other plant material, or combinations thereof, whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this nature. Herbal medicines may contain excipients in addition to the active ingredients. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants, are not considered to be herbal medicines.
Exceptionally, in some countries herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin.
The past decade has seen a significant increase in the use of herbal medicines. As a result of WHO’s promotion of traditional medicine, countries have been seeking the assistance of WHO in identifying safe and effective herbal medicines for use in national health care systems. In 1989, one of the many resolutions adopted by the World Health Assembly in support of national traditional medicine programmes drew attention to herbal medicines as being of great importance to the health of individuals and communities (WHA 42.43). There was also an earlier resolution (WHA 22.54) on pharmaceutical production in developing countries; this called on the Director-General to provide assistance to the health authorities of Member States to ensure that the drugs used are those most appropriate to local circumstances, that they are rationally used, and that the requirements for their use are assessed as accurately as possible. Moreover, the Declaration of Alma-Ata in 1978 provided for inter alia, the accommodation of proven traditional remedies in national drug policies and regulatory measures. In developed countries, the resurgence of interest in herbal medicines has been due to the preference of many consumers for products of natural origin. In addition, manufactured herbal medicines from their countries of origin often follow in the wake of migrants from countries where traditional medicines play an important role.
In both developed and developing countries, consumers and health care providers need to be supplied with up-to-date and authoritative information on the beneficial properties, and possible harmful effects, of all herbal medicines.
The Fourth International Conference of Drug Regulatory Authorities, held in Tokyo in 1986, organised a workshop on the regulation of herbal medicines moving in international commerce. Another workshop on the same subject was held as part of the Fifth International Conference of Drug Regulatory Authorities, held in Paris in 1989. Both workshops confined their considerations to the commercial exploitation of traditional medicines through over-the-counter labelled products. The Paris meeting concluded that the World Health Organisation should consider preparing model guidelines containing basic elements of legislation designed to assist those countries who might wish to develop appropriate legislation and registration.
The objective of these guidelines, therefore, is to define basic criteria for the evaluation of quality, safety, and efficacy of herbal medicines and thereby to assist national regulatory authorities, scientific organisations, and manufacturers to undertake an assessment of the documentation/submission/dossiers in respect of such products. As a general rule in this assessment, traditional experience means that long-term use as well as the medical, historical and ethnological background of those products shall be taken into account. Depending on the history of the country the definition of long-term use may vary but would be at least several decades. Therefore the assessment shall take into account a description in the medical/pharmaceutical literature or similar sources, or a documentation of knowledge on the application of a herbal medicine without a clearly defined time limitation. Marketing authorisations for similar products should be taken into account. (Report of Consultation; draft Guidelines for the Assessment of Herbal Medicines. World Health Organisation (WHO) Munich, Germany, June 1991) ... herbal medicine
In the , such a document has no legal force, but doctors will normally respect patients’ wishes.... living will
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