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PAPERS PRESENTED AT THE EXPERT CONSULTATION (Contd.)

E. LEGAL AND REGULATORY ISSUES FOR THE MANAGEMENT OF GLOBAL ANIMAL GENETIC RESOURCES AND THE APPLICATION OF RELEVANT BIOTECHNOLOGIES

A preliminary review1

1 Background

From its early days FAO has been active in the field of animal genetic resources. Animal genetic resources have been subject to various conservation and management programmes since 1973. Appropriate methods for characterizing breeds and for storing germplasm have been developed and, in 1983, a joint FAO/UNEP Panel of Experts on Animal Genetic Resources Conservation and Management was established in order to coordinate and further the efforts in this field. Due to lack of funding, the Panel of Experts met only once in 1983 and again once in 1986.

In 1987, FAO embarked on the establishment of Regional Animal Gene Banks which are to become regional focal points for the cryogenic storage of semen and embryos in Africa, Asia and the Pacific, Latin America and the Caribbean. The action plan for the programme provides that two centres are to be established in each region for the storage of semen and/or embryos of threatened breeds. Once training has been provided, participating countries in each region will contribute to the gene banks free of charge.

FAO has also worked together with the European Association of Animal Production (EAAP) to establish in 1988 the EAAP/FAO Global Animal Genetic Data Bank in Hannover, Germany, for the purpose of storing genetic characterizations and population census data2. The data bank will be used to produce a World Watch List of Threatened Breeds and to provide an Early Warning System to governments.

2 Recent decisions of FAO governing bodies on the animal genetic resources programme

In April 1989, the Tenth Session of the FAO Committee on Agriculture (COAG) reviewed the FAO programme of animal genetic resources3. The COAG recommended its expansion into a globally effective system in order to offer support to all member countries wishing to take part.

1 FAO Legal Office.

2 Animal Genetic Resources, A Decade of Progress 1980–1990, Annex V, p.35. FAO, Rome, June 1990.

3 Report of the Tenth Session of the Committee on Agriculture (COAG), CL 95/9, June 1989, paragraphs 121–140, p. 14–16.

The FAO Council, at its 95th meeting in June 1989, recognized that animal genetic resources were part of the larger topic of biological diversity and called for the programme to be expanded and further developed4. Consequently, an Expert Consultation on animal genetic resources was held in September 19895. The Working Group of the Commission on Plant Genetic Resources, at its October 1989 meeting, considered the same subject.

The FAO Council, at its Ninety-eighth Session in November 1990, recommended that FAO prepare a detailed programme for the sustainable development of animal genetic resources on a global level6. The FAO Council, at its Ninety-Ninth Session in June 1991, endorsed the plans for the preservation and improvement of animal genetic resources, and supported the COAG's recommendation to hold an Expert Consultation to consider an action programme and necessary legal instruments to protect animal biodiversity7.

3 Integration of institutional infrastructures for animal and plant genetic resources within one system

During its 95th Session, in June 1989, the FAO Council requested the Director General to examine the possibilities of integrating the institutional infrastructures for animal and plant genetic resources within one system, while at the same time taking account of the relationships and needs of fisheries and wildlife8. The Expert Consultation on FAO programmes for the preservation of animal genetic resources, held in Rome in September 1989, recommended that animal genetic resources should not be incorporated into the FAO Undertaking on Plant Genetic Resources due to issues (for example ownership, access and rights) specific to animals and clearly different from those affecting plants9.

4 Report of the Council of FAO, Ninety-fifth Session, June 1989, CL 95/REP, Paragraphs 60–63.

5 Animal genetic resources: a global programme for sustainable development. FAO Animal Production and Health Paper No.80, 1990. Recommendations and Proceedings of the FAO Expert Consultation, September 1989.

6 Report of the Council of FAO, Ninety-eighth Session, November 1990, CL98/REP, Paragraph 84. See also: A Programme for the Sustainable Development of Animal Genetic Resources, CL 98/16-Sup. 1, November 1990, paragraphs 14–23.

7 Report of the Council of FAO, Ninety-ninth Session, June 1991, CL 99/REP, Paragraph 47.

8 Report of the Council of FAO, Ninety-fifth Session, June 1989, CL 95/REP, Paragraphs 62.

9 Animal genetic resources: a global programme for sustainable development. FAO Animal Production and Health Paper, No. 80, 1990. p.viii, para 8.

At its Ninety-eighth session, November 1990, the FAO Council discussed the widening of the mandate of the Commission on Plant Genetic Resources to become a commission on biological diversity for food and agriculture, which would include plant and animal genetic resources. The Council agreed that the subject needed to be further discussed by both the Commission on Plant Genetic Resources and the Committee on Agriculture (COAG), taking into consideration technical, legal, institutional and financial implications10.

At its Ninety-ninth Session in June 1991, the FAO Council noted that COAG had examined the question of widening the mandate of the Commission on Plant Genetic Resources to include inter alia animal genetic resources, but did not agree to broaden the mandate at this time. The Council recommended calling an Expert Consultation to assist in making a more informed judgement about the desirability of establishing a separate forum for animal genetic resources. Such an Expert Consultation would also assess the proposed programme on animal genetic resources11.

10 Report of the Council of FAO, Ninety-eighth Session, November 1990, CL 98/REP, Paragraphs 85.

11 Report of the Council of FAO, Ninety-ninth Session, June 1991, CL 99/REP, Paragraph 58.

4 The precedent of the plant genetic resources system

In terms of institutional structure, the FAO Global System on Plant Genetic Resources developed since 1983 is relatively advanced. The objectives of the Global System are to ensure the safe conservation, and promote the unrestricted availability and sustainable utilization of plant genetic resources for present and future generations, by providing a flexible framework for sharing the benefits and burdens. The System covers the conservation (ex situ and in situ) and utilization of plant genetic resources at molecular, population, species and ecosystem level.

The basic institutional components of the system are:

  1. A flexible framework, the International Undertaking on Plant Genetic Resources.

  2. An intergovernmental forum, the Commission.

  3. A financial mechanism, the International Fund for Plant Genetic Resources.

To date, some 130 countries are formally part of the Global System, through becoming members of the Commission, or adhering to the International Undertaking, or taking both steps.

5 The relevance of the plant genetic resources system

It is widely recognized that there are important differences in the biology, technology and methodology, and social and economic orientation between animal and plant genetic resources. Animal genetic resources are, in practical terms, more subject to private ownership than plant genetic resources. In fact, most species or breeds of animals of economic importance seem to be already in private ownership. This means that access to and rights on animal genetic resources present specific problems.

Nevertheless, a number of important lessons which could be of some relevance to the institutional and regulatory aspects for the management of global animal genetic resources can be drawn.

  1. Financial resources required to support an effective programme are not likely to be forthcoming on a sustainable basis. Inactive collections of un-utilized materials do not attract conscientious capable curators and the quality of information about the materials, if not the material itself, declines.

  2. Information on environmental, as well as genetic background of preserved materials, is critical to efficient utilization for scientific and economic purposes.

  3. The development of an international institutional support for animal genetic resources has to cope with political and economic concerns as well as with possible activities of other institutions. In this respect the mandates and objectives of the FAO programme should be precisely defined.

  4. An important lesson from experiences with Plant Genetic Resources gene banks is that good documentation and good organization are essential elements in order for these banks not to remain under-utilized. In addition, design and management of data banks should be done in concert with gene banks to ensure that essential data are available, possibly under the umbrella of the same institutional structure.

6 The definition of genetic material in the context of animal genetic resources

Discussions are currently underway within the Intergovernmental Negotiating Committee for a Convention on Biological Diversity on a definition of genetic material or genetic resources. On a provisional basis, “genetic material means hereditary material found in living organisms or parts thereof. The characteristics of an organism are derived from this material”.

In addition, a provisional definition of “animal genetic resources” is under discussion at the FAO Secretariat level in connection with the preparation of an International Undertaking on Animal Genetic Resources which is being prepared:

"Animal genetic resources means: the animals themselves as well as all somatic or germinal cellular lines belonging to:

  1. species, subspecies and breeds currently exploited or newly created;

  2. outmoded species or breeds;

  3. feral or related wild species;

  4. special genetic lines."

From a legal point of view, the effectiveness of any global management of animal genetic resources will be dependent upon a clear technical definition of its objectives. It will also be necessary to define the kind of animals to be included into the International Undertaking on Animal Genetic Resources.

7 Institutional structures

The global system for Animal Genetic Resources could be built on the model of the instruments which already form the FAO global system on Plant Genetic Resources. They would be as follows:

  1. The International Undertaking on Animal Genetic Resources:

    This could be an international legally non-binding agreement that would provide for identifying potentially valuable animal genetic resources that are in danger of becoming extinct as well as other animal genetic resources in the country which may be useful for development and for taking appropriate legal and other measures for their conservation and sustainable use. It should be based on the principle that animal genetic resources are subject to the sovereign rights of states.

    FAO's technical divisions and the legal office are currently working on a draft International Undertaking on Animal Genetic Resources which could provide a solid and equitable system, taking into account the rights and obligations of donors and recipients of germplasm.

  2. The Commission on Animal Genetic Resources:

    A Commission on Animal Genetic Resources could be the intergovernmental global forum to monitor the operation of the Undertaking and to recommend measures that are necessary or desirable in order to ensure the comprehensiveness of the Global System and the efficiency of its operation in line with the Undertaking.

    The Commission should review, in particular, all matters relating to the policy, programmes and activities of FAO in the field of animal genetic resources, and to give advice to the Committee of Agriculture.

  3. The International Fund for Animal Genetic Resources:

    An International Fund for Animal Genetic Resources could provide a channel for countries, inter-governmental and non-governmental organizations, private industry, and individuals to support the conservation, and promote the use of animal genetic resources on a sustainable basis, at world level. In the long term, the International Fund should become a critical element in ensuring the equitability of the Global System.

A number of other international agreements or arrangements may prove necessary to facilitate the conservation and the use of animal genetic resources.

8 Regulatory aspects of animal biotechnology

There seems to be a great potential for biotechnology in the conservation and use of animal genetic resources.

A draft Code of Conduct on Biotechnology is being prepared on an issue-by-issue basis, in close collaboration with the appropriate organizations, taking into account the equitable sharing of the benefits of biotechnology between the developers of that technology and the donors of the germplasm it uses.

Emphasis should be put on training scientists and technicians of the developing countries in the use of appropriate technologies, especially biotechnologies, so as to ensure the effective transfer and utilization of such knowledge.

9 Legal aspects of animal patenting

The subject of animals is perhaps the most complex class of products to which patent protection is to be extended. The complexity stems from the legal issues associated with anything as individual as a multicellular animal: from the complexity of the science involved with such sophisticated life forms, and from the mammoth size of the potentially affected industries12.

Regarding the patenting of animals, various approaches have been followed in national legislation.

  1. Concerning United States, the US Patent and Trademark Office (PTO) has issued in April 1987 a formal pronouncement of the patentability, in principle, of “non-human” multicellular organisms, be it plant or animal, that were not “naturally occurring”13.

  2. Concerning Europe, the Commission of the European Communities presented a “Proposal for a Council Directive on the Legal Protection of Biotechnological Inventions” on October 17, 1988.

    As regards the patentability of products of animal biotechnology, the draft directive ensures the patentability of living matter in general and clarifies the point that any exclusion of animal varieties shall not extend to the patenting of parts of animal varieties. Finally, the draft directive clarifies that surgical or diagnostic methods practised on an animal body are excluded from patent protection only if practised for a therapeutic purpose.

    Thus such methods as embryo recovery and transfer employed for animal production should be patentable in European Community member states in the future. The eventual adoption of the European Community draft directive would make the legal status of European law comparable to that of the USA.

12 See Animal Patents, the Legal, Economic and Social Issues, Stockton Press 1989, p.xi.

13 See the “Ex parte Allen” decision, Board of Patent Appeals and Interferences, April 3, 1987.

10 Impact on national and regional levels

It is expected that country level activities should greatly facilitate the establishment of national animal genetic resource programmes. The basic activities at national level would consist of the preparation of an inventory of available animal genetic resources. The establishment of appropriate national infrastructures providing support for national programmes and reviewing the situation of animal genetic resources should be recommended.

Assistance could be also provided to developing countries in order to carry out a wide range of activities including census studies, genetic characterization, preservation in situ and ex situ, documentation, genetic improvement, comparative evaluation and exchange of germplasm.

Regional level activities will be focused on the existing Regional Animal Gene Banks. An important contribution of the regional centres will be also to provide technical and, where necessary, material assistance to national governments cooperating in the Regional Animal Gene Bank. With regard to the legal status of the germplasm collections of the regional centres, a review of establishments and headquarters agreements of centres holding and maintaining germplasm collections should be carried out.


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