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Application of herbal drugs to health care in Japan.

Kampo, derived from traditional Chinese medicine, has been adopted in Japan for centuries, and the demand for herbal drugs is increasing. At present herbal drugs are utilized in pharmaceutical forms such as granules of the extracts. A special commission has evaluated and selected traditional prescriptons for their efficacy and safety by clinical experience. The Kampo preparations are also accepted by the national health care insurance. About 80% of the plants used are imported. The Japanese Pharmacopoeia reports 116 herbal drugs, the majority of Chinese origin, under specifications established and reviewed by the Pharmacopoeia Committee. In Japan, high quality research, which has developed during the last century, has partly ascertained the active principles in the herbal drugs and pharmacological tests have also been adopted, although limitations exist in the modern pharmacological methods. The handling of herbal drugs is limited to licensed pharmacists in order to ensure their good management.

Education, Medical↗

Ethnopharmacology versus chemosystematics in the search for biologically active principles in plants.

The chemicals to which Brazilian angiosperms owe their use in the preparation of arrow poisons, hallucinogens, fish poisons, drugs, stimulants, spices, perfumes and pigments are correlated with the systematic position of the species in which they occur. Most compounds are produced either by the primitive Magnoliidae (sensu Cronquist) or by the advanced Asteridae. The Rosidae-Dilleniidae, precisely the group of subclasses of widest distribution over the country, have heretofore yielded relatively few useful compounds. This fact can be rationalized by the presence in their species of massive quantities of gallo- and ellagitannins, general defences which make the presence of specific alleochemics superfluous. The natural occurrence of specific biologically active compounds is thus ecologically and systematically conditioned and it should be possible to build a system capable of predicting the existence and the nature of useful chemicals in plant taxa.

Animals↗

A neglected Mayan galactagogue - ixbut (Euphorbia lancifolia).

A herbal tea, made of leaves of ixbut (Euphorbia lancifolia Schlecht.), has been used for several centuries by postpartum Mayan women in Guatemala to stimulate and increase the flow of mother's milk. Ixbut, when mixed with cattle fodder, is reputed to have increased milk yields in cows. To date, the active principle of ixbut has never been isolated. However, this medicinal herb, a natural galactagogue of Central American origin, would appear to be worthy of further chemical and pharmacological study. The following illustrated article describes the history and use of ixbut, and includes chromatographic analyses of dried ixbut leaves from Guatemala.

Adolescent↗

The pharmacological evaluation of natural products--general and specific approaches to screening ethnopharmaceuticals.

Natural product research is most efficiently conducted in a systematic fashion concentrating on ten critical questions which must be answered in sequential fashion by thoroughly trained professionals experienced in such research. The minimum ethnopharmacology research team should consist of a botanist, a chemist and a pharmacologist with each carrying the responsibility for answering certain of the critical questions. The screening procedures used for the evaluation of synthetic medicinals generally are not appropriate for guiding the extraction of active principles from crude drugs and establishing extraction efficiency; therefore, specialized techniques unique to ethnopharmacology must be used.

Chemical Phenomena↗

Inventory of plants used in traditional medicine in Somalia. I. Plants of the families Acanthaceae-Chenopodiaceae.

Thirty-eight plants are listed, which are used by traditional healers in the central and southern parts of Somalia. For each species are listed: the botanical name with synonyms, collection number, vernacular name, medicinal use, preparation of remedy and dosage. Results of a literature survey are also reported including medicinal use, substances isolated and pharmacological effects.

Animals↗

The tradition of medicinal plants in Zagori, Epirus (northwestern Greece).

Traditional herbal medicine in the Zagori region of Greece was studied by obtaining information from users and collecting herbs. In addition, traditional remedies found in old manuscripts and books were compared with those currently used in modern literature. The 36 medicinal plants used today are listed, including their common and scientific names, indications (some new) and recipes for preparations.

Greece↗

Biodiversity prospecting and benefit-sharing: perspectives from the field.

Searching for new biologically active compounds from natural sources starts, obviously, in the field. Plant, microbial or animal materials to be sought and investigated may be selected through a number of approaches. No matter what selection criterion(a) is (are) used, the first step in obtaining the organism concerned is to undertake field collecting work to search for and to collect the organism. Good knowledge on the ecogeographic distribution and precision in the taxonomic identification of the organism(s) sought are crucial if the field work involves the search for a pre-determined organism or set of organisms. Such knowledge and precision during field work are of secondary importance, however, if the search and collection are based on biodiversity or ethnomedical uses, since accurate taxonomic identification may be made at a later date, in a Museum or Herbarium environment. When an individual or institution from a biotechnologically developed country wishes to obtain indigenous raw biological material from a biotechnologically less developed country, an agreement for the procurement of such raw material may be negotiated. Since the effort to search and develop a biologically active compound(s) from natural sources is a long-term process that involves teamwork between field and laboratory scientists, the success of the endeavor will depend in large part on the continued flow of raw material from the field. Goodwill to maintain such a flow may be achieved through appropriate scientific and monetary compensations, both in real-time and in long-term sharing of the benefits of discovery. Only with the prospect of financial return to the supplying country will there be an incentive for the protection of the natural resources towards sustainable use and development, as well as to allow time for continuing explorations and discoveries.

Animals↗

The position of intellectual property rights in drug discovery and development from natural products.

Some practical working definitions and perspectives are offered here as to "intellectual property' (IP) and "intellectual property rights' (IPR), particularly as they may pertain to the essential contributions of the parties to an international cooperation or collaboration in drug discovery and development from natural products. Existing and new intellectual properties are examined particularly in respect to feasible ways in which they may be appropriately recognized and protected. It is further illustrated how such suitable recognition and protection may provide the basis to insure fair and appropriate compensation for contributions of existing intellectual property essential for the creation of new intellectual property. The importance of an adequate mutual understanding, and shared realistic perspective, of the overall process and probability of outcome of any given drug discovery and development venture, is emphasized.

Conservation of Natural Resources↗

Natural products research: perspectives from a major pharmaceutical company.

Natural products research continues to provide a tremendous variety of lead structures which are used as templates for the development of new drugs by the pharmaceutical industry. Advances in bioassay technology and in chemical methodology have combined to make natural products a cost effective source for new leads. While microbial products have been the mainstay of industrial natural products discovery, in recent years phytochemistry has again become a field of active interest. Drug discovery programs based on microbial products and phytochemicals are discussed and contrasted.

Animals↗

Natural product source material use in the pharmaceutical industry: the Glaxo experience.

Glaxo PLC has had a significant involvement with Natural Product Source Materials for all of its commercial history and, most recently, has pursued this interest by use of such materials as templates for new lead discovery. Through the expertise and facilities in its Natural Products Discovery Department, Glaxo extracts relatively small quantities of plant material (typically 200-250 g dry weight) and cultures microorganisms from environmental samples (typically 10-50 g). Extracts and fermentation broths are screened in order to detect bioactive principles (BPs). If the potency, selectivity and specificity of the BP is acceptable, isolation, purification and structural elucidation follows. It is most unlikely, in our experience, that the BP itself will become a drug; it is much more likely that we shall need to initiate a medicinal chemistry synthesis program in order to try to produce a molecule that has both the essential biological and desirable chemical properties to become a drug development candidate. This synthetic process is often a long one and our confidence that such a process is worth undertaking is greatly improved if the BP is novel. An essential component of any medicinal chemistry strategy is that it allows us to obtain secure intellectual property rights through patents. Acquisition of product claim protection, the strongest form of patent protection, is of great importance. Safety testing and clinical development of the candidate drug can take 7-10 years, and often more, during which patent protection is constantly eroding. Recognizing that acquisition of Natural Products Source Materials is an issue of growing concern, Glaxo Research and Development Ltd. (GRD), in the early part of 1992, implemented a policy for plant supply. This policy was subsequently modified to embrace source materials such as environmental, soil and marine samples from which fungi, micro- and microorganisms may be obtained. As a direct consequence of this policy, Natural Product Source Materials supply agreements are only concluded with national and international organizations who possess the expertise to identify and collect the samples. It is equally important that our suppliers have the authority, which must be provided to GRD in writing, to collect such materials and to provide them to GRD for extraction and screening purposes. Such materials must be from sustainable and accessible sources. We will not seek to collect any endangered species. Though ethnomedical information can be helpful, it is not essential. Plants must be taxonomically classified. We reimburse the supplying institute for their efforts and their expertise, and recognize an obligation to offer a royalty to the institute in the event that drug discovery, with subsequent commercialization, owes its origin, however indirectly, to a material that it provided. In discussions with the institute, we insist that "a fair proportion' (>40%) of that royalty be used for the direct benefit of the people in the collection source area. In this context, GRD recognizes the importance of local training and education.

Drug Evaluation, Preclinical↗

Biological diversity, indigenous knowledge, drug discovery and intellectual property rights: creating reciprocity and maintaining relationships.

When new plant-derived therapeutics based on indigenous knowledge are being explored, it is important that the pharmaceutical companies return benefits to the native populations and the local governments from which the research material was obtained. When a potentially marketable plant product is being developed, it is essential that equitable agreements have already been established between the pharmaceutical companies and the people and/or countries from which this indigenous knowledge was acquired. Equally important is the commitment to provide immediate reciprocity that will enhance the welfare, the biocultural diversity and the well-being of the forest peoples. These measures should commence when a research project begins and continue during its duration. The development of these measures must be based upon the expressed needs of the indigenous communities. The relationship between the stability of the rain forest biocultural diversity, the creation and development of agro-forest resources and the long term benefits to the forest people is highlighted. Examples of initiatives taken by Shaman Pharmaceuticals Inc. and the Healing Forest Conservancy are described and discussed in the context of exploring appropriate use of intellectual property law to address the ethical issues facing all business and research groups working in the tropics.

Awards and Prizes↗

Academic research: policies and practice.

The Bayh-Dole Act of 1980 allowed universities in the US to own and manage inventions obtained using federal funds. This Act laid the foundation for university technology transfer activities in most major research universities of the country. Consequently, the interaction between universities and industry has increased, and so has the sophistication in university intellectual property management. UIC's model for managing its intellectual property is efficient and successful, and is the one increasingly used by university technology transfer offices. The model deals with all aspects of UIC's intellectual property: disclosure, protection, marketing, negotiating and licensing, as well as intellectual property provisions in UIC's research agreements, material transfer agreements, option agreements, licensing agreements and others. In a pioneer effort, UIC has developed a policy on contracts for collecting natural product samples for drug discovery which includes royalty sharing and other important provisions. Accompanying this policy we have also drafted a standard contractual agreement for collectors.

Authorship↗

Legal issues in sharing the benefits of biodiversity prospecting.

The National Cancer Institute (NCI) is the US Government's principal agency for research on the prevention, diagnosis and treatment of cancer. A critical component of the Institute's mission is the identification and development of new and promising treatments for cancer and AIDS. For many years these efforts have included a program to investigate natural products for potential new therapeutic agents. In 1986, with the advent of new screening techniques, the National Cancer Institute stepped up its exploration of natural products and began world-wide collections of plants in tropical and subtropical regions. In recognition of the principles of the Biodiversity Treaty, NCI appreciates that continued access to the natural products of these countries depends on the Institute's ability to recognize the contributions of these source countries and their indigenous peoples, and to provide them adequate incentives to conserve their natural resources for the purposes of drug discovery. Accomplishing this goal presented several legal issues for the National Cancer Institute. As an agency of the US government, the NCI has an adjunct statutory mission to facilitate the transfer of technology developed through the Institute's programs into the private sector for further development and commercialization, and NCI operates under a national policy to use the patent system to transfer Federally supported research to the private domestic sector. Reliance on patent law may limit the Institute's ability to recognize the rights of source countries and their indigenous people and provide compensation for their contributions. However, other legal instruments, such as contracts, can serve as interim measures to provide compensation to source countries and indigenous populations. The National Cancer Institute's Letter of Collection agreement (LOC, formerly the "Letter of Intent'), is an example of an alternative means that "fills-in the gaps' created by patent law and through which source countries may share in the benefits of natural product development.

Conservation of Natural Resources↗

Medicinal plant genetic resources and international cooperation: the Brazilian perspective.

Brazil is a gene rich country, host to 24% of known primate species, between 10 and 15 million species of insects, and 22% of the world's higher plant species. The debate over how and by whom these resources should be protected has intensified over the last few years due to a growing awareness of the links between sustainable utilization of natural resources, conservation of biodiversity, and economic development. Within this context the pharmaceutical exploitation of natural products for drug development has a prominent place. For a significant portion of Brazilian society, fair cooperation is welcome and can facilitate drug discovery. Nevertheless, the complexity of the consequences of patenting and utilization of natural resources calls for a thorough cost/benefit analysis in order to promote policies that can ensure significant and long term benefits for the country.

Brazil↗

Rules and regulations on the collection in Cameroon of biological materials for biological testing and drug discovery.

Regulations on the exploitation of Cameroon's rich biodiversity have tended to emphasize timber exploitation at the expense of non-timber uses. Materials for scientific research have been marginalized. However, in-service instructions usually provide practical guidelines such as specific charges that researchers must pay for the collection of samples. Even though the current law and text of application are silent on regulations addressing the scientific "prospecting' or exploitation of the forests, it is hoped that a particular text in conformity with the current regulations will provide more specific rules governing the collection, testing and exportation of biological materials for drug testing and discovery.

Animals↗