「マニラ宣言における」バイオ探索研究の契約ガイド

MANILA DECLARATION
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Introduction
Scientists in the Asian region have long recognized that exploitation of their biological resources, notably medicinal plants, has rarely been of direct benefit to either Asian　scientists or the economic development of the region.
　
One of the resolutions of the Symposium on the Development of Drugs from Plants, 26-28 October 1989, in Manila, was that the natural plant heritage of each country should be respected and explored for the benefit of that country. In addition, it was resolved that collaboration with foreign scientists should be conducted on a mutually acceptable basis and where possible, training of local scientists should be included.
　
The Seventh Meeting of the Asian Coordinating Group for Chemistry [ACGC VII] held in Xiamen, People’s Republic of China, 5-7 February 1990, discussed Asian concerns over the exploitation of biological materials. This theme, concerning the collection of plant specimens and the role of Herbaria, was further discussed at the UNESCO-sponsored Botany 2000 Herbarium Curation Workshop held in Perth, Australia, 15-19 October in the same year. A code of Ethics for Foreign Plant Collectors developed at the meeting has now been modified to cover all biological materials, including marine organisms.
　
The exploitation of biological resources has also been dealt with in the Summary of the Workshop on Drug Development, Biological Diversity, and Economic Growth by J. Schweitzer et al. (1991) in Journal of the National Cancer Institute, Vol. 83;1294-98.
　
The Seventh Asian Symposium on Medical Plants, Spices and Other Natural Products (ASOMPS VII) held in Manila, Philippines 2-7 February 1992, concluded with an Open Forum on the Ethical Utilization of Biological Resources.

The open Forum has resulted in the following Manila Declaration, together with its appended Code of Ethics for Foreign Collectors of Biological Samples and Contract Guidelines.

Concerning
The Ethical Utilization of Asian biological resources

Developed at the Seventh Asian Symposium on Medicinal Plants, Spices and Other Natural Products (ASOMPS VII) which was held in Manila, Philippines from 2 to 7 February 1992 and was attended by 283 scientists from 31 countries.
　
Given that:

1. the maintenance of biological and cultural diversity is of global concern
2. developing countries are major centers of biological and cultural diversity
3. there is increased interest in biological material with medicinal and/or other economic value
4. indigenous peoples frequently possess knowledge that provides a key to natural products of economic value.

Recognizing that:

5. all national governments have sovereignty over their biological resources.
6. current practices of exploitation of biological resources and indigenous knowledge are frequently inequitable, favoring technologically advanced organizations and/or developed countries, to the disadvantage of both conservation and development in the country or region of origin.
7. there is need for further investment in training and technology in developing countries and for equitable partnerships with developed countries in order to obtain new products from biological material.
8. there has been insufficient acknowledgement of the essential role that indigenous knowledge (i.e. intellectual property) plays in identifying important natural products.

Thus, it is recommended that:

9. national governments, with advice from appropriate professional organizations within the region, develop adequate legislation to exercise control over the collection and export of biological material
10. as a high priority, governments, international agencies, multinational corporations and academic institutions, through training, laboratory construction and technology transfer, should support the development of human and material resources needed for all aspects of local biological evaluation of indigenous materials for conservation and for managed development
11. for all collecting, the authorizing agreement(s) should include provision for any subsequent commercial development that may eventually arise
12. internationally recognized professional societies develop a code of ethics that facilitates the formation of equitable partnerships in the development of new products from biological material.
13. mandatory royalty or license agreements be established to ensure fair and equitable distribution of benefits to the region of origin
14. supply agreements should only be made by the appropriate country organization and not with individuals in that country
15. in order to avoid over exploitation of promising species, the country organization should adopt methods to protect the identity and provenance of its biological material
16. specific regulations be established to ensure that the collection and export of biological material is adequately monitored and controlled in the interest of the country supplying the material. These should include the requirements that;

　16.1 collections are made together with local counterparts appointed by the country organization involved
　16 2 adequately annotated, preserved voucher specimens of biological material are lodged in appropriate national institutions
　16.3 sufficient funds are provided by the external organization to cover the support costs which may be incurred
　16.4 if there is a threat of destructive harvesting, provision must be made for sustainable harvesting or development of alternative supplies
　16.5 the traditional knowledge of local participants contributing to development of new natural products must be recognized as significant intellectual property.
　
Code of Ethics for Foreign Collectors of Biological Samples
[ Appendix 1 ]
　
The reference document was developed at the Botany 2000 Herbarium Curation Workshop held in Perth, Western Australia, 15 to 19 October 1990. It was modified in April 1992 to cover other biological material.
　
The foreign collector should:
・　arrange to work with a local scientist(s) and institute(s) respect regulations of the country visited; for example, by entering on a research/collecting visitor visa, not a tourist visa, and by observing regulations for export of biological specimens, quarantine, CITES, etc.
・　obtain official permission for all collections in National Parks or protected areas.
・　ascertain whether items used in scientific work and which are difficult to obtain can be contributed.
・　when applying for a travel study grant, include equal travel expenses for local counterpart(s) and an amount to cover the cost of processing museum specimens or other costs of the visit to the host institute
・　leave a complete set of adequately labelled duplicates with the institute before departing the country.
・　ensure that Types of species described as a result of the research are deposited in the National Museum or Herbarium of the country of origin.
・　inform the institute in the country of origin where duplicate specimens are to be deposited.
・　not exploit the natural resources of the host country by removing high value biological products through collecting wild specimens, for example plants with potential horticultural, medicinal, cultural or other economic value, without prior permission.
・　obtain a list of rare and endangered species of the country visited and not collect these species without permission.
・　collect no more material than is strictly necessary; for live plant specimens, collect cuttings or seeds rather than uprooting whole plants; for marine specimens, wherever possible, collect subsections rather than whole organisms.
・　leave copies of photographs/slides for the host institute(s)
・　inform the host institute/appropriate organization of new localities of rare/ endangered species found
・　remember to send copies of research reports and publications to collaborator(s) and host institute(s)
・　acknowledge collaborator(s) and host institute(s) in research reports and publications
・　collect identified reference voucher specimens for all biological products to be exported.

CONTRACT GUIDELINES
[ APPENDIX 2 ]

ASOMPS s VII recognizes that there is considerable variation in the levels of technical expertise for the development of new natural products in the region. There is also recognition that every effort should be made to reduce dependency by developing countries on technology held by developed countries. However, in the short-term, efficient development of new natural products may involve sharing of biological resources and technology between developed countries and the countries of origin.

In order to avoid contracts which do not achieve equity in partnerships between developed countries and the country of origin, there are suggested minimum standards which should be used:
　
・　The amount of material collected for initial screening should not normally exceed 100-500 grams (dry weight) unless specific permission is obtained.
・　Payment should include all handling expenses and infrastructure costs.
・　Where screening of extracts is carried out with the aid of a partner organization in the developed world, a minimum of 60% of any income arising from the supply of extracts to commercial organizations should be returned to the appropriate country organization.
・　The country organization should receive a minimum of 51% of any royalties arising from external collaboration that results in marketable products. Since a fair royalty would be of the order of 3-5%, the appropriate country organization should receive a minimum royalty of 1.5-2.5%.
・　The country organization should not sign agreements that give indefinite exclusive rights to any external party. Exclusivity should be limited to no more than a two-year period.
・　Complete evaluation of results of any screening should be reported to the supplying country organization within a reasonable specified period.
・　If there is a threat of destructive harvesting, costs of sustainable harvesting or development of alternative supplies must be borne by the external organization.
・　The contribution of research participants should be recognized through co-authorship of publications.
・　Initial preparation of extracts and screening should be done in the country of origin and assistance to develop this expertise should be provided wherever practicable.

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