WORLD FEDERATION FOR CULTURE COLLECTIONS (WFCC) WORKSHOP

THE ECONOMIC VALUE OF MICROBIAL GENETIC RESOURCES

At the Eighth International Symposium on Microbial Ecology

Halifax, Canada, August 12th 1998



Sponsored by:
European Union(DGXII),
Organisation of the American States,
Health-Canada






[1] SUMMARY



The WFCC Workshop on the economic value of microbial geneticresources brought together microbiologists, economists and culture collection experts to discuss the complex issues that need to be considered in trying to assess the economic value of microbial diversity. The objective of the workshop was to publish the presentations and the conclusions of those present as an aid to policy makers, environmental microbiologists and the curators of microbial resource centres who require an answer - for a variety of reasons- as to what price can be put on microorganisms and their value to society.

The programme included presentations covering the current state of knowledge of in situ microbial diversity, the costs of maintaining ex-situ resources and the specialist services they provide, the cost benefits associated with specific groups of microorganisms following research into the value of their activities, and different approaches that could be taken to assess economic value. Relevant on-going international initiatives were also described. Although figures were provided showing the estimated value of the use of microorganisms to the pharmaceutical industries, the food industries or as nitrogen fixers in agriculture, calculations of the value of in-situ microbial activity were considerably harder to achieve.In-situ microbial diversity could be considered as the world's natural culture collection that maintained itself, was largely unknown and was continually changing to meet new environmental conditions. Economists present asked if the survival of these microorganisms was threatened, since scarcity or impending loss would greatly affect their value, and did the microbial biosphere need conservation? Microbiologists considered that habitat loss could lead to extinction of certain species, but that for many species, ubiquity was the norm. What was undoubtedly missing was wider knowledge about interactions between microorganisms and other life forms and this was essential to gain a true understanding of 'biodiversity'. New technology was closing the knowledge gap, but a lack of resources for further research and a lack of taxonomic expertise hampered progress.

The situation with regard to ex-situ resources was clearer, sinceit is possible to calculate the cost of detecting, isolating, identifying, studying and preserving microorganisms ex-situ. Although it was suggested that a microorganism in-situ had no value and that value was only acquired through the transition from in-situ to ex- situ, it was generally held by participants that there was always an intrinsic value to microorganisms in-situ . The question was raised as to whether all isolates should be maintained even if they remain unused, and who should bear the cost of this. Examples were given of isolates that have remained unused for very many years yet subsequently became major production strains in new processes, or highly valuable research tools. It was asked whether unread books in a library have no value? Should they be destroyed? Who should pay for their preservation?

During the extended discussions that followed the presentations it became clear that the workshop was considered by participants to be a valuable first step towards developing aneconomic analysis of microbial diversity. It was a first meeting of the economic and microbiological minds and it emerged that there was a need for improved communication between the disciplines (definition of terms used, for example) in order to reach an informed analysis in the future. The workshop participants considered it was important to establish the value of microorganisms for a) supporting the implementation of the Convention on Biological Diversity, b) establishing access and benefit-sharing arrangements, c) providing policy makers with the evidence needed to justify greater resource al location to research inmicrobial diversity and d) supporting the infrastructure of ex-situ providers (research and service collections).

They felt that it was difficult to estimate in-situ values but recommended that more research effort, particularly where economists and microbiologists worked together,would provide better models on which to base estimates. It was considered that it was easier to establish the value of ex-situ resources and that this was a necessary and valuable exercise.

It was widely held that the public perception of the value of microorganisms to the maintenance of the biosphere was almost non-existent or often misplaced ('microorganisms cause disease') and that a public-awareness programme on the essential role and positive benefits of microorganisms to life on earth would be very valuable. This would have the added benefit of reinforcing the value of a nation's microbial resources for consideration in national accounting systems.

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[2] PROGRAMME



HALIFAX WORLD TRADE AND CONVENTION CENTER, August 12, 1998

08:30 REGISTRATION
09:00 WELCOME AND OVERVIEW
09:30 ECONOMIC VALUE OF BIOLOGICAL DIVERSITY

Chair : B Kirsop, (UK), Co-chair : D.K.Song, (China)

10:30 COFFEE
11:00 ECONOMIC VALUE OF EX-SITU COLLECTIONS

Chair : L. Sly, Australia; Co-chair : V. Canhos

12:00 DISCUSSION chaired by L.Sly, Australia
12:30 LUNCH
13:30 APPROACHES TO ASSESSING VALUE AND PROMOTING INCENTIVES

Chair: C. Takase, CBD Secretariat; Co-chair: J. Staley

14:30 THE VALUE OF MICROORGANISMS AND GENOMIC INFORMATION

Chair: D.Van der Mei, Netherlands; Co-chair: H.Sugawara, Japan

15:30 TEA
15:45 INTERNATIONAL INITIATIVES AND PLANS

Valuation, Access / Equitable Sharing and Bioprospecting

Chair : A.Doyle,UK

16:45 PLENARY DISCUSSION AND RECOMMENDATIONS

Chair : B.Kirsop; Co-chair : J.Hunter-Cevera, US

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[3] RECOMMENDATIONS



The workshop recommended that:

1.
There was a need for further research into microbial biodiversity and its interaction with higher life forms in order that models could be established for estimating the economic value of microorganisms in situ. Such research should involve both environmental microbiologists and economists and could be new research or incorporated into appropriate on-going programmes.


2.
The value of ex-situ microbial resources should be established so that the costs of their maintenance could be estimated and realistic figures used in establishing access and benefit sharing arrangements.


3.
The true value to the biosphere of microbial activity should be better presented to policy makers and the general public so that the role of microorganisms are understood and appropriate resources are allocated for a) further research into closing the knowledge gap and b) the maintenance of ex-situ resource centres as holders of the known microbial archive and providers of associated scientific services.


4.
The dearth of taxonomists who are needed to carry out much of the work was recognised and strong recommendations were made that this shortage be reversed through national and international programmes.

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[4] ABSTRACTS (as at September 1998)





WELCOME AND OVERVIEW

WFCC: Its Present Activities and Plans for the Millennium.

Vanderlei Canhos (vcanhos@bdt.org.br);

Barbara Kirsop (Barbara@biostrat.demon.co.uk)

The WFCC has had an active period promoting the work of the Federation, operating both through its executive board and committee members, and in a general consultancy capacity toother organisations. It is now planning for the new millennium.

Traditionally, the WFCC holds a major Congress every 4 years. The event in the year 2000 is to be held in Brisbane, Australia. The overall theme will be microbial resources for the new millennium, and the programme will be wide-ranging to cover the multiple interests of culture collections and their users. The first announcement is already published on the WFCC Web Site and in the July 1998 Newsletter.

Becoming also traditional, is the organization of an additional activity between Congresses, and the present workshop on 'The Economic Value of Microbial Genetic Resources' has been arranged to continue the work of the WFCC and its Biodiversity Committee. This committee has been represented, and has observer status, at a number of meetings relating to the Convention on Biological Diversity (CBD), including the 3rd and 4th Conferences of the Parties of the CBD. It has been able to raise awareness on the importance of maintaining distribution of material for research and educational purposes as well as for industrial development.

It has produced a publication on access to ex-situ microbial resources that has been widely distributed and summarised by the CBD for distribution to all governments that are parties to the CBD.

The importance of capacity building is a major element of the CBD requirements, and here the WFCC's Education Committee is working to identify the needs of countries and regions for training in culture collection matters. WFCC members are well used to contributing to regional and international workshops and this work continues in, for example, Latin America and the Asian regions, as well as in the training programmes of some of the major culture collections.

The work of the Committee on Postal, Quarantine and Safety Regulations overlaps with that of the Biodiversity Committee in a number of areas and its recent publication has proved very valuable. It, together with the Patents Committee, continues to keep a watching brief on regulatory developments and works to ensure that policy makers are aware of the needs of the international microbiological community and the daily activities of culture collections in meeting these.

The active operation of any international organisation is difficult when resources for meeting are limited, and it is significant that the WFCC has been able to continue its work in many areas, thanks in large part to electronic communication mechanisms and its Web Site. Thelatter is held at the WFCC's World Data Centre on Microorganisms (WDCM),National Institute of Genetics, Japan, where pages are maintained on all the Federation activities. The WDCM database on collections and their holdings continues to provide an important resource for the scientific (and policy-making) community and is currently encouraging the up-dating of information from contributing collections. It plans a meeting in Tokyo inearly 1999 to consider collaborative collection activities to meet such complex needs as the genomic developments and the mega-science forum.

Electronic links are also playing a major part in the development of regional collection networks. Thus, the Asian Information Network for Microbial Research, reported in the recent WFCC Newsletter, is a distributed system for sharing information on microorganisms that enables collections to build their own Web Servers, maintain their own information and develop bioinformatics capacity in their countries. Local Internet connectivity allows tasks and costs to be shared.

The WFCC's Executive Board is preparing for the Congress in the year 2000 by ensuring that any revisions to the Statutes are finalised and made available for comment by the Membership both through the Newsletter and the Web Site. It has also agreed to up-date the well-used publication, 'Guidelines for the establishment and operation of collections of cultures of microorganisms'.

In summary, the Federation has organised and has plans for a number of important meetings and activities, and continues to be make its expertise available to organisations such as the CBD, OECD and its parent organisation, the IUMS, as needs arise. There are currently many issues of international concern that impact on the daily work of microbial resource centres and the WFCC welcomes support from fellow-scientists in its work to resolve uncertainties and ensure continuing access to essential microbial material. The political issues (such asaccess, safety, benefit-sharing, 'bioterrorism' ) cannot be ignored by the Federation and its members, yet the WFCC is aware that its major role is support for science and the contribution of specialist expertise and research in taxonomy, preservation and related disciplines.

___________________________________________________________



Relevant developments under the CBD process on the economic value of microbial genetic resources.

C. Takase (chikako.takase@biodiv.org)

The Convention on Biological Diversity adopts the ecosystem approach in order to ensure the consideration of the essential processes and interactions amongst organisms and their environment. The ecosystem functioning depends to a great extent on the health of micro-organisms. At the fourth meeting, in its decision IV/1, the Conference of the Parties(COP) requested the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) to further elaborate the ecosystem approach and to report to the fifth meeting of the COP.

The specific consideration of the micro-organisms has been given under the agricultural biological diversity, where the issue is most relevant. However, to a certain extent the consideration was also given under the issue of the access to genetic resources and fair and equitable sharing arising out of their use. On agricultural biological diversity, the third meeting of the COP adopted decision III/11, paragraph 16, which "encourages Parties to develop national strategies, programmes and plans which should focus interalia on ... (c) micro-organisms of interest for agriculture". Paragraph 11 of the same decision encourages interested Parties and international organizations to conduct case studies on the two initial issues identified by SBSTTA in recommendation 11/7.

These two issues are contained in the annex 3 of the decision, namely (i) pollinators and (ii) soil micro-organisms in agriculture. The latter was expanded to cover soil biota by decision IV/6 adopted at the fourth meeting of the COP. On access and benefit-sharing, the third meeting of the COP received the information document from the World Federation for Culture Collections on access to ex-situ microbial genetic resources within the framework of the Convention on Biological diversity. The COP adopted decision III/15 on access to genetic resources, which called for relevant information. For the fourth meeting of COP, the Secretariat produced three documents for issues relating to access and benefit-sharing, UNEP/CBD/COP/4/21 - 23. In particular, document 4/21 has a focus on the distribution of benefits from biotechnology in accordance with Article 19 and contains issues related to microorganisms. The COP adopted decision IV/8, in which it drew up ways to further the issue of access and benefit-sharing.

First, it requested the inter-sessional open-ended meeting,established by decision IV/I 6, to explore options for access and benefit sharing mechanisms and to work towards the development of a common appreciation of the relationship between intellectual property rights and the relevant provisions of the TRIPs Agreement and the CBD. Second, it decided to establish a regionally balanced panel of experts in order to develop a common understanding of basic concepts and to explore all options for access and benefit-sharing on mutually agreed terms, including guiding principles,guidelines, and codes of best practice for access and benefit-sharing arrangements. Third, it requested the Executive Secretary to invite information from Parties and relevant organizations in respect of those exsitu collections which were acquired prior to the entry into force of the CBD and which arenot addressed by the Commission on Genetic Resources for Food and Agriculture of the FAO. Fourth, the Executive Secretary is requested to explore the possibility of linking the CHM with relevant organizations to access publicly available information on IPR which arebased on biological resources. Fifth, the exercise of compiling relevant information, including case studies, and facilitating the exchange of information is requested to continue. In addition,IV/5 on marine and coastal biological diversity, programme element 2, Marine and coastalliving resources , aims, as one of the operational objectives, to make available to the Parties information on marine and coastal genetic resources, including bioprospecting.

The outcome of the fourth meeting of the COP will form the basis ofthe work of the CBD towards the fifth meeting, which is scheduled in May 2000. We call for further support and collaboration.








ECONOMIC VALUE OF MICROBIAL DIVERSITY

The Value of in-situ Microbial Diversity.

James T. Staley (jstaley@u.washington.edu)

Microbiologists are just beginning to learn of the vast diversity of microbial life on Earth. What is known already indicates that the physiological, metabolic, genetic and phylogenetic diversity of microorganisms is unparalleled by any other life forms. Microorganisms were the original living organisms on Earth and their biogeochemical activities have sustained the biosphere for about 4 Ga (109 years).

Thus, microbial life 'set the table' for all subsequent life forms which evolved from them. Atmospheric oxygen produced by cyanobacteria with its accompanying protective layer of ozone which reduced the effects of damaging ultra violet radiation enabled the evolution of land plants and animals. Microbial activities continue to play important roles in the biogeochemical cycles of carbon, nitrogen and sulfur and other elements enabling eco systems to recycle these substances into utilizable forms for all living organisms. Agriculture, forestry and fisheries are examples of commercial activities that are dependent on and sustained by these basic microbial activities. Waste water and solid waste treatment and bioremediation are other examples of the use of microorganisms to transform animal, plantand industrial wastes into non-toxic, utilizable materials. In addition, the vast genetic diversity of microbial life has provided a resource for pharmaceutical and biotechnology industries.

Economic values can be placed on some of these processes and products. Ultimately, the very existence of all life on Earth is dependent on microbial diversity. Culture collections play avital role in maintaining cultures of all the diverse microbial species that are needed by commercial firms, educational institutions and research organizations. Recently, new molecular procedures have indicated the existence of a vast diversity of previously unknown and uncultivated species from all environments including soils, marine and fresh water habitats. This major finding has intensified the search for and cultivation of these new microbial species. As the many thousands of new microbial species are described and cultivated, there is an increasing urgency to provide the necessary resources and capacity to handle this new-found biological wealth to culture collections.

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Value of microbial diversity for biotechnological applications.

J.C.Hunter-Cevera (JCHunter-Cevera@lbl.gov)

Microorganisms have been employed by industrial microbiologists (biotechnologists) to produce products and processes that improve our health, our food and environment. The true value of microbial diversity includes not only the diversity with respect to species richness but also the direct and indirect economic value of profits resulting from commercialization of microbial metabolic products and processes. Examples will be presented of how certain biotechnological industries were and still are in search of specific products and processes and how use of screens based on microbial diversity both at the organism and molecular level hasand still does provide novel discoveries.








ECONOMIC VALUE OF EX-SITU COLLECTIONS

The Value of Ex-Situ Microbial Resource Centers.

Erko Stackebrandt (erko@gbf-braunschweig.de)



The value of microorganisms

The value of any biological resource can be defined ecologically, scientifically and commercially:

1.
The ecological value of a microbial strain (better: cells there of) refers to its function in an ecosystem. Any biological specimen is somehow involved in the global cycles of assimilation and dissimilation of organic and in organic matter. Some, more than others, are crucial in the sustainability of higher life forms on the planet Earth but knowledge about the importance of an organism in ecosystem functioning is sparse. The economic value of a non-isolated cell can be ignored while the ecological and the scientific value may be high once its function in the environment has been elucidated.


2.
The scientific value of a strain, originating from thorough scientific studies, leads to an increase in knowledge about history, presence and (eventually) predictable future of life. It is not so much the information obtained from a single strain but preferably from its deduced or determined inter actions with other strains that broadens the intellectual horizon.


3.
Exploitation goes beyond the satisfaction of scientific curiosity although curiosity may have been an important impetus for commercialization. In contrast to a single strain, biomass has anenormous potential economic value. Each level of information (DNA-RNA-proteins) is a target for commercial interests. Only recently strategies have been developed (gene expression of cosmid library clones) which do not focus on isolated strains. The economic value of a strain is defined by the present goals of the biotec industry and the degree of exploitation of strains, genetic material or gene products. Both, exploitation of isolates and products of recombinant technologies are usually not verified within laboratories of a genetic resource center; this means that the role of such centers is restricted to the cheap end ofexploitation, i.e. provision of strains.




How to add economic value to a strain?

If one assumes that a strain in its environment has no obviouscommercial value, how is valueadded.

*
Value is added through the isolation process in that scientists, technical staff and equipment are moved to the isolation place, enrichment cultures are set up and the like. At this stage the most valuable organism is the one isolated at a remote place (as judged from the location of there searcher) and requiring special attention for its isolation.

*
The value is significantly increased by long term deposition in a collection. The preparation of 20 ampoules (DSMZ standard) per strain amount to approximately DM 400 (ECU 200, US$220), irrespective of the potential and actual commercial value of the strain.

*
Additional value is added by taxonomic analysis. The more thorough the analysis the more precious the culture. It can be assumed that the description of a novel species according to the polyphasic approach will range between a few thousand and ECU 10.000 (also depending upon the skills and writing experience of the investigator). Thus, any type strain of a new species is a valuable asset given to the collection for free by the investigator.

*
At this stage the economic value of a deposited strain is only maintained by its sale (the situation is different in the pharmaceutical industry). While the long term attractivity for sale can only be predicted for certain reference strains (e.g. quality controlstrains) the demand for strains other than these is difficult to predict.

*
The economic value of a deposited strain is dramatically decreasing when the interest of customers in this strain is vanishing or when it is not requested at all. Over time, the value may actually drop to nearly the value of an as yet uncultured strain (n.b. the scientific value may still be high).




The diversity of Genetic Resource Centers

The problems of discussing the value of ex-situ collections is the wide range of types of collections. It extends from small but highly specialized collections (high taxonomic value, mainly housed in university departments), over (almost) fully funded collections (governmental support), to (almost) self supportive collections (commercial companies) but most collections combine several of these elements. As not only the purpose of collection but also even within any of such categories the range of taxa as well as the scientific work is different, the degree of economic value is difficult to assess. For the ease of demonstration only two types of microbial collections are compared which are here termed competitive and non-competitive collections. Both types of these resource centers cover part of their expenses through the sale of their resources:



--Type of Collection--

Non-competitive Competitive
many Strains of high public demand many
many Type strains of a wide spectrum of taxa few
high Number of uncharacterized strains low
intensive Taxonomic research low, if any
variable Service variable
provision of diversity Main function commercial enterprise
high Public funding low to none


The dilemma which the majority of publicly funded resource centers face is obvious: The more uncharacterized strains and the more expensive taxonomic work the worse the relation between expenses and income. Let us assume a total asset of 10.000 lyophilized strains, including 3.000 prokaryotic type strains. For ease of calculation the total number of ampoules is 400.000 (including the re-lyophilized strains which are sold). Based upon the above mentioned figures, 8.0 million ECU must be provided for the lyophilization process. As these strains are not preserved within a single year but over a period of 20 years, the annual average load is 400.000ECU. It is not uncommon that over a period of several years about 70% of total strains (7.000strains) are not sold at all. Of the remaining 3.000 strains, 10.000 ampoules are requested by customers at an average price of 40.00 ECU. Thus the total income is 400.000 ECU which is equivalent to the amount needed for preservation. If however, the number of not-requested strains is kept to a minimum the income of resource centers would be increased significantly.

However, each curator and the majority of administrators of funding agencies are aware of the fact, that the majority of resource centers have not been established for commercial reasons. Another important reason is the establishment of centers of taxonomic excellence, especially in times, in which taxonomic expertise is rapidly declining, e.g. in academia. Excellent research in taxonomic methods and identification, made visible to the scientific community through lectures, publications, workshops and the like, is a reflection of the collections quality and the engagement of its staff. As outlined in the graph, the direct value of the primary services of resource centers is increased, i.e. the reputation of a collection within the community of customers is promoted, when the resource center presents itself at the fore front of scientific / taxonomic research.

A third important reason for the establishment of a resource center other than from a purely commercial point of view is the holding of less characterized strains which may become the focus point of future scientific and biotechnological interest. These strains are collected either because of taxonomic interest of the curator, or of scientific necessity (e.g. literature strains). Most of these strains are of little value (if at all) to the customer, although they are sometimes requested from the pharmaceutical industry to be included in large screening programs. Most likely none of these thousands of strains will follow the fate of Thermus aquaticus but remain the costly burden of collections.



How to reach a balance between costs of maintenance and income?

If the financial burden is identified to be caused mainly by the costs of maintaining strains which are of no immediate commercial interest, different strategies can be followed: introduction of less expensive preservation methods; reduction of strains and a more selective acquisition policy; agreement between resource centers on mechanisms for avoiding the collection of redundant strains.

If the first option is chosen, strains with no immediate needs could be preserved in liquid nitrogen until requested. Although the number of requests will not be predictable the introduction of freeze drying regimes will facilitate future handling and shipping. As for most of these strains thorough taxonomic studies are lacking simple but reliable methods should be applied to at least characterize these strains to the species level and to a level where biosafety requirements are satisfied.

While any curator will be reluctant to reduce the number of unidentified strains by autoclaving the biological material, future acquisition of strains can follow several strategies, such as (i)collecting strains of described species only; (ii) collecting only strainswhich may be of scientific interest as they have been included in the scientific literature; (iii) concentration on certain eras of expertise, environments, or physiological types. Other examples may be added easily. The former head of the DSMZ, Dr. Dieter Claus indicated to me not to collectthose strains which can be easily re-isolated from the environment. The problem with this strategy has been identified by the finding that the genomic diversity of strains of superficial phenotypic similarities may be extensive. Thus, discarding isolates at an early stage of study may result in the removal of potential new species. However, it is not the responsibility of a resource center to include the check for novelty at a large scale. The collection may contribute to add scientific value (expensive way) by describing strains as type strains of novel species. This way the value-added type strain may catch the attention of the scientific community.

There is no question that no collection will be able to collect more than a glimpse of the natural diversity of microorganisms. The introduction of molecular tools to studies on microbial ecology has renewed the interest in isolation procedures. Indeed, the search for organisms which have been identified to be present in an environment by the novelty of their 16 SrDNA sequence has resulted in the recovery of many novel taxa. Due to the rather complex, polyphasic requirements for the description of a prokaryotic species the increase of newly described species is still small and does not pose problems to resource centers. Large collections of less well identified isolates with potential high commercial value are maintained mainly under the direction of individual researchers who will keep the collection until the scientist is close to retirement or when collections are threatened by the administration of the institution in which it is maintained. Only then the call for deposition in a publicly funded resource center become surgent and these centers are in most instances not in a position to immediately react towards acquisition. It is obvious that a national resource center located in a taxonomically active environment will have great problems to fulfill its responsibilities. As indicated above, the higher the number of little characterized strains the lower cost efficiency.

More than other scientists and administrators, curators agree that the value of a resource center should not be judged on the income based on the sale of relatively few strains. The value of a collection includes the potential commercial value of strains of no immediate interest, and the knowlege about their role in ecology and evolution. However, the rather uncontrolled collection of biological material must be considered history. If diversity of less characterized isolates is going to be maintained in the future, large resource centers with public funding must agree on acquisition and pricing policy, collaboration to minimize maintenance costs and strain redundancy. This strategy appears to be one option to maintain a high degree of strain diversity, to serve public and science and to comply to the articles of the Convention of Biological Diversity.

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The economic value of microbial diversity information.

Lois Blaine (lblaine@atcc.org)

The culture collections of the world, both service and research oriented, hold a treasure trove of information that must be fully mined to exploit its value as a base line for measuring the economic potential of the estimated 2 million + undescribed microorganisms on earth. It is well known that microbes have a positive as well as a negative financial impact on human society, e.g., the essential role they play in the multibillion dollar pharmaceutical industry vs.the equally large cost of human illness caused by major pathogens. Building robust databases that can be used to analyze the phylogenetic and physiologic relationships among these organisms is a prerequisite for making sound decisions on the preservation of specific microbial ecosystems.

While it is not realistic to believe that representatives of all living microorganisms will be preserved ex situ, culture collection databases can be used as templates on which to measure the diversity of environmental isolates or nucleic acid samples. Genomics, a growing field in which computational tools are used to derive function from structure, can help to identify unique genes and functional pathways present in the preserved strains. New isolates can be matched against this index to assess their potential value. Culture collections, because they represent a microcosm of the world's biodiversity, must take the lead inproviding the foundation on which further discoveries can be made and priorities set for conservation of those organisms most useful for sustained development. The value of taxonomic, phylogenetic, phenotypic, and industrial applications data as perceived by the American Type Culture Collection and its response to the new paradigm of the culture collection as "information center" is presented.








THE ECONOMIC VALUE OF EX-SITU COLLECTIONS

The view of IDAs (International Depositary Authorities under The Budapest Treaty for the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.

Dagmar Fritze (dfr@gbf-braunschweig.de)



Why patent deposits, why patent deposits in CCs ?

Biotechnology patents need to meet the requirements of the'mechanical' patent system (inventiveness, novelty, utility, sufficiency of disclosure).
Full disclosure requires the availability of the biological material -if it is of importance for the patent- in supplementation of the written documents, to enable others to rework the invention.
Availability of the biological material needs to be continuous, from the first date requested by the relevant patent system, to at least the end of the life of the patent.
Availability of the biological material needs to be independent from the influence of the patent holder.
Patent offices would, technically, not be able to perform the task.



What are the aims of a patent ?

The deposited material is, like the written patent documents, one part of the mutual agreement between the patentee and the society.
An inventor, who agrees to disclose his invention to the publicearly and completely (instead of working under trade secret) is granted patent protection on his invention.
His intellectual property is recognized and for a limited period of time (the life of the patent) he is granted an exclusive right to market his invention, that is he is allowed to prohibit unauthorized use of his invention.
Through the early dissemination of knowledge it is achieved that the technical, commercial,and social developments are furthered and others will be stimulated to invent, invest and innovate.
After the period of monopoly has ceased, the invention be comes available to any-body without restrictions.



What are the tasks of an IDA ?

To fulfil the requirements of the Budapest Treaty (BT) and to be recognized as an international depositary authority, a depositary must

-
be located in and be approved by the contracting state

-
have a continuous existence

-
have the necessary staff and facilities

-
be impartial and objective

-
be available to any depositor on the same basis

-
accept certain kinds of microorganisms, examine their viability, and store them as prescribed in the regulations

-
issue receipt and viability statements

-
comply with secrecy agreements

-
furnish samples in conformity with the regulations


It is known that quite a broad range of biological material may be deposited. The term 'Microorganism' is stated in the BT but not defined. The definition of the European Patent Office says that material may be deposited for patent purposes which is carrying genetic information and is capable of self reproduction or which can be reproduced in a biological system.

As the tasks of a depositary embrace not only storage, but also cultivation, testing of viability, long-term preservation, etc. the IDAs rely on the knowledge and experience of expert staff.



Examples and Figures

Today 30 IDAs have been recognized worldwide in which about 35.000 deposits have been made under the BT. Each of these deposits may have one or several patent applications in its background.

Numbers of deposits worldwide under the Budapest Treaty (deposits under national law not included)

Year 1984 1989 1993 1996 Total ('81 -'96)
Deposits 1129 2321 2489 2621 30.081
Releases 113 227 365 412 3.934 (without ATCC)
% 10% 10% 15% 16% < ?!

Figures taken from WIPO Industrial Property Statistics, '97 not yet available.

Figures for ATCC BT releases not available.



To give an impression of the proportions of all patent deposits versus BT deposits the DSMZ is used as an example and the releases there of shown.

Deposits '81 to mid '98 Releases
All patent deposits at DSMZ 4300 -
BT deposits at DSMZ 3400 600

(during the last 15 years virtually no non-Budapest deposit was made)



Proportion Releases <> Deposits

% BT releases to BT deposits 18%
% BT releases to individual BTdeposits 11%

The ` 600 samples have been released from only ` 380 deposits.



Of course, these figures do not represent the direct real 'value'-and especially not for the culture collections in terms of sales- but behind these figures the interest of competitors is hidden. However, this is an indirect value and not easy to be quantified. Obviously, there are deposits of higher or lower interest. As an example, a small number of patent strains deposited in '81 have been requested repeatedly for more than 15 years now from requestors all over the world, and today it is clear that a fierce battle was going onto attack and defend the related patents. The deposited material was needed to test the invention.

How many patent applications have been made before the European Patent Office (EPO)which needed the deposit of biological material? (Figures rounded, unofficial information from the EPO)



Year Patent Applications, general Patent Applications in Biotechnology Patent Applications with deposit(s) Patent Applications
containing se-quence protocols
1994 74000 (100)* 1400 (100)* 450 (100)*32%** 959 (100)*
1995 78000 (105) 1600 (114) 545 (121) 34%** 1205 (125)
1996 86000 (116) 1800 (128) 455 (101) 25%** 1157 (120)
1997 99000 (134) 2600 (185) - -

* = figures in brackets are percentages, value of 1994 = 100%; ** = percentages of biotechnology patents; - = not yet available



The numbers of patent applications in biotechnology clearly grow faster than the over all numbers of applications. About a quarter of all biotechnology applications needed as support the deposit of biological material. It seems as if the number of deposits may fall in future. Patent applicants do try to avoid deposits because the fear of too easy misuse of the active biological material is great. A new development is that, where possible, gene sequences are provided.

However, patent attorneys still advise to deposit: the whole value and validity of a patent may depend on a correct deposit. It does happen sometimes, that it is found out only later (by competitors) that for full disclosure of a patent the deposition of certain biological material would have been needed, and then the patent may be lost.



Aspects for judging value: 'direct value'

One approach could be to compare biotechnology patents to the more established chemical patents and to look at market shares of certain products.

The top on the pharma market is said to be a pharmaceutical of company Glaxo against stomach problems, this is said to have about 5 Billion market share. In the biotechnology sector, the top is said to be held by the Erythropoietin patent, with about 2,3 Billion market share. For this patent biological material had to be deposited to guarantee full disclosure. Hoffmann-LaRoche bought some time ago the PCR-patent from the original patent holder for more than 300 Millions although only 10 years were left from the life of the patent. This patent was also endorsed by the deposition of microorganisms.

There are obviously real 'hits' among biotechnological patents, but what about about all the other numerous deposited samples of biological material ?



Aspects for judging value: 'indirect value'

Comparison with industrial 'way of life'

When talking to people from the big industries, it is interesting to hear of their way of calculating costs and of their 'market strategies' with respect to patents and revenues: it is estimated that for developing 1 marketable product about 3000 ideas stand in the beginning.



Company Strategies

3000
ideas in the beginning of these

600-700
concrete of these ideas deserve to be discussed

150
patent applications evolve from these

100
patents are granted from these

40
real projects are formulated internally (at that stage 60% of the patents could be rated useless if judged short sightedly) from these

20
remain over the time for furtherdevelopment, according to internal politics, finances,overall development etc. from these

1-2
are filtered down

and

1
product/process is put onto the market


So, less than 0.1 % of all the ideas develop an immediate,countable market value.

The inexperienced person would expect to become rich from every good idea, from every patent. But experienced companies think differently and know it better. The term of the 'stand-by idea' exists, which means in case a challenge comes up, the idea to solve the problem may be already at hand, one of the many 'useless' ideas and patents left behind on the way to the final product. All these need to be seen as a stock, a plentiful from which one can freely select. So, eventually, an idea, judged as being not useful enough ata time, may under different circumstances, develop a useful life (or is even sold to another company).

This scheme can be transferred to deposited biological material : even if only a small percentage of deposited strains receive an immediate interest, all the others may bear the potential of becoming of importance later.



Indirect value of BT deposits with an IDA

A number of things could be listed: e.g. the advantage for patent applicants that only one deposit is needed internationally; or the advantage for national industries that it is not necessary to transport the biological material across the borders.

But perhaps the most important facts are:

Value for society:

-
through the deposited material full disclosure of the patent is achieved

-
access to the deposit for the public without interference through the depositor is guaranteed

-
availability for more than 30 years is guaranteed

-
unimpeded reworking of the invention and control ofpatent claims is possible

-
furthering of development is facilitated

While at the same time safety from the view of the depositor is guaranteed because:

-
no own responsibility for maintenance of the biological material

-
the biological material is held at a neutral place

-
access to the deposited material is according to independent regulations only.


___________________________________________________________



Global Economic Value of the Arbuscular Mycorrhizal Symbiosis and a Living International Culture Collection (INVAM).

Joseph B. Morton (jmorton@wvnet.edu)

The arbuscular mycorrhizal (AM) symbiosis became established over 400 million years ago between soil fungi (putative Zygomycetes) and the first land plants. Both partners have since coevolved together, with more than 80% of all terrestrial plants from almost any habitat dependent to varying degrees on the fungus and the fungus obligately requiring the host plant. The economic value of the fungal symbionts is estimated by the cost of phosphorus (P) inputs to sustain similar levels of plant productivity without the fungi presentand including the following considerations:

(1)
a global land area of 9.2 billion hectares encompassing sixbiomes with terrestrial plants,

(2)
relative proportion of plants likely to form AM symbioses ineach biome, and

(3)
P rates based on a P level at which mycorrhizal and nonmycorrhizal legumes showed equivalent growth and adjusting for general mycorrhizal dependency of plants in each biome.


From these data, $549 billion of P input would be needed to substitute for native AM fungi. This estimate does not take into account the mortality of many tree and other species so dependent that fertilizer applications would be ineffective. The international culture collection (INVAM) of AM fungi costs approximately 0.0002% of that value, yet it performs valuable functions to recovery and maintain germplasm and facilitate research to understand the biology and ecology of AM fungi. In research, method ologies have been developed to bait native fungi in pot cultures, induce sporulation so that healthy spores can be used to establish monospecific cultures on plants for distribution and use. Completion of these steps require atl east one year per bait culture. The germplasm bank provides well-characterized living material for comparative research at all scales and also provides a wide range of taxa for systematic studies.

The collection houses a library of reference materials that has been used to construct a biogeographic database for assessing worldwide distribution of fungi and measurement of complexity of fungal communities. Germplasm also is provided to educators for training at all levels and to students for science fairs, graduate studies, and demonstrations. Seed inocula are provided to fledgling companies seeking to produce inocula for large-scale inputs, such as ecological restoration of disturbed sites. Infectivity assays and other service functions identify fungi and the quality of commercial and research inocula. From a conservation viewpoint, germplasm sources in danger of mortality and/or extinction are revived, maintained and stored.








APPROACHES TO ASSESSING VALUE AND PROMOTING INCENTIVES

Economic Valuation of Microbial Diversity - Is it worth it?

Anthony Artuso (artusoa@cofc.edu)

Consideration of just a few examples, such as the symbiotic microorganisms living within our bodies, the fixation of nitrogen by bacteria, the leavening of bread, and the fermentation of wine, is enough to indicate the importance of microbial life to human health and happiness. It is fair to say that the total value of microbial life forms to the human race is immeasurable. Fortunately, there seems to be no danger of whole sale elimination of microbial diversity. Indeed, the tremendous adaptive capabilities of microorganisms virtually ensure high levels of microbial diversity. So is the economic value of microbial diversity really an area of research worth pursuing? This question must be considered separately forin-situ and ex-situ collections of microbial organisms

With regard to in-situ microbial diversity, economic valuation is a purely academic exercise unless there is some evidence that certain communities or species of microorganisms are threatened with extinction or might otherwise be harmed in ways that would reduce human benefits. If micoorganisms are not being adversely affected by human or natural activities that could be altered by humans, there is little reason to try to estimate their economic value.

It is of course quite possible that some ecosystem services orother benefits generated by microbial diversity could be impaired by anthropogenic causes. Ahypothetical example would be wide spread damage to beneficial soil microorganisms as a result of acid precipitation or other pervasive forms of pollution. It should be noted that these detrimental effects could conceivably occur even without the extinction of particular species of microorganisms. It is possible that important biogeochemical cycles could be disrupted simply by changes in the frequency and densities of various species of microorganisms inparticular habitats. Indeed, it is theoretically possible that these habitats could experience an increase in the diversity of microorganisms (defined in terms of number of species) and still have impairment of certain functions important to humanity.

Many of the difficulties involved in valuation of ecosystem services are not attributable to the primitive state of environmental economics. The truth is we know very little about the role of microorganisms in maintaining soil fertility or the ability of communities of microorganisms to naturally adapt to changing conditions while maintaining critical ecosystem functions. These are questions that biologists and ecologists must answer before relevant economic analyses can be undertaken. Even assuming we have adequate understanding of the essential biological and ecological processes, policy relevant valuation of potential losses in ecosystem services due to disruption of microbial processes cannot be accomplished simply by estimating the dollar value of crop losses or other damages that would occur. Valuation estimates must consider whether full or partial substitutes for microbial processes are available or could be developed. Again, using the example of beneficial soil microorganisms, it is important to determine whether additional fertilizers or soil additives could at least partially substitute for any impairment of microbially assisted natural processes. It is also possible that genetically engineered microorganisms could be developed to substitute for naturally occurring species that were unable to adapt to anthropogenically modified conditions.

The analytical steps involved in determining whether and how to value the ecosystem services of microbial diversity can be summarized as follows:

*
Determine if anthropogenic processes are altering microbial communities;

*
Determine to what degree these alterations might significantly impair ecological processes that are of direct or indirect importance to humans;

*
Estimate the value of the potential impairment of ecological processes;

*
Identify any measures (other than eliminating the original cause) that could be taken to at least partially restore or mitigate the loss of these ecosystem services.

*
Estimate the cost and effectiveness of these measures;

*
Identify the least costly combination of mitigation measures and losses due to impairment of microbial communities.


Unfortunately, the analysis outlined above can rarely, if ever, be conducted in a deterministic fashion. Risk and uncertainty will inevitably be present. Recognition of this fact often leads to calls for adherence to the precautionary principle or application of a safe minimum standard. While these approaches may at times be appropriate, they should only be adopted after an explicit evaluation of our knowledge and assumptions about the probability of detrimental effects and their potential value. This implies recasting the analytical process outlined abovein a stochastic, decision theoretic framework.

Another potentially relevant policy issue and valuation problem arises out of the potential chemical and genetic value of in-situ microorganisms. As with other forms of life, it is possible that a threatened ecosystem provides habitat for microorganisms that are not found anywhere else. The destruction of a unique ecosystem might therefor cause the extinction of numerous forms of microbial life. Economic value of the microbial diversity of unique ecosystems is a function of the number and type of endemic microbial lifeforms found there, the probability of discovering commercial applications from these endemic microorganisms, and the probability that these commercial applications could not be developed as easily fromother microorganisms or life forms.

In addition to providing ecosystem services, many valuable commercial products have been developed from microorganisms. Most antibiotics have been derived from microorganisms and the emergence of new and drug resistant diseases is intensifying the search for new antibiotics. Microorganisms are also the source of many forms of natural crop control, are increasingly being used in bioremediation efforts, and are the source of the genetic reproduction processes that spawned the biotechnology industry. Inrelation to research and development of new uses of microorganisms, the relevant measure of microbial diversity is not the estimated number of species living on the Earth or in particular ecosystems but rather the number of cultures that can be obtained at a reasonable expense. In this case the policy issue is not so much conservation but rather knowledge of and access to microbial diversity.

While there has been substantial discussion in the literature and at international meetings about the general need for biodiversity surveys and ecological research, there seems to be no systematic effort under way to expand our knowledge of microbial diversity, collect new samples and increase the size of cultures collections. Given the well known commercial potential of microorganisms, this seems to be a policy issue worthy of further attention. Economic valuation efforts could contribute to this policy analysis by providing estimates of the value of (1) increasing the diversity of microbial organisms readily available for research and development of new products, and (2) increasing the supply of information on the taxonomy, biochemistry and ecology of microorganisms.

Unless there is evidence that in-situ microbial communities are being transformed in potentially harmful ways, sophisticated economic valuation of in-situ microbial diversity is not likely to be worth the expense. However, given the numerous commercial uses of microbial organisms, a strong argument can be made for economic analysis of the benefits of microbial research, from sampling and collection through curation and biochemical and genetic evaluation.

___________________________________________________________



An economic analysis of the Convention on Biological Diversity : Access and rents.

Joseph Henry Vogel (josephvogel@usa.net)

Access to biological diversity has become increasingly valuable due to advances in biotechnology over the last two decades. Just as biological diversity became a resource for biotechnology in the developed countries, it was being exterminated as the consequence of habitat loss in the developing countries. An economic solution to this inefficiency is the internalization of the multiple externalities of habitat conservation which would include access to biological diversity for bioprospecting. However, until very recently, access was free and legally protected under the doctrine known as the "common heritage of mankind". With the ratification of the Convention on Biological Diversity (CBD) in 1993, some 170 + countries rejected "the common heritage of mankind" and began enclosure. The USA remains the exception.

Article 3 of the CBD establishes that each nation is sovereign over its genetic resources and Articles 16 and 19 permit the negotiation of access to genetic resources inexchange for benefits. Because genetic resources are usually not unique to one countrybut diffused over many countries, the economist expects the price of genetic resources, in acompetitive market, to be driven down to the marginal costs of collection-essentially restoring the pre-CBD doctrine of the "common heritage of mankind". A corollary also exists regarding traditional knowledge associated with biological diversity. Many traditional communities employ plantsand animals for myriad uses that could provide leads for R&D.

Article 8(j) of the CBD "encourages the equitable sharing of the benefits arising from the utilization of such knowledge, innovations, and practices. " Like the diffusion of genetic resources over countries, this knowledge is also usually not unique to one community or even one ethnic group; if each community is empowered to negotiate access to traditional knowledge, the price of that knowledge will be driven down to the marginal cost of being interviewed. Economic theory implies that rents can only be captured through the formation of an oligopoly that fixes the price of access and distributes the economic rents among all countries and/or communities that could have supplied the same genetic resource and / or associated knowledge. Microorganisms present a special challenge for benefit-sharing and bioprospecting. Due to the ubiquity of many microorganisms and the concomitant difficulties in policing access and ascertaining origins, the costs of distributing the rents may be higher than the rents collected. However, if microorganisms were to remain free, then the biotechnology industry would have an incentive to substitute micro- for higher organisms simply because that access is free. In such cases, the solution may be to dedicate the rents from access to microorganisms toward the fixed costs involved in creating the databases needed for the benefit sharing of bioprospecting higher organisms.








THE VALUE OF MICROORGANISMS AND GENOMIC INFORMATION

Economic Valuation of the Diversity of Biological Nitrogen Fixing Microorganisms in Agriculture.

Heitor L. C. Coutinho (heitor@cnps.embrapa.br),

Norma G. Rumjanek (cnpab@cnps.embrapa.br),

Eduardo Cadavid & Johanna

Biological nitrogen fixation (BNF) is a major component of the global nitrogen cycle, and therefore, of utmost importance for agricultural systems, specially in low fertility tropical soils, where nitrogen is a limiting factor. BNF contributions to the economics of legume crop production, for example, are very significant. Microorganismscapable of fixing nitrogen provide this element for plant growth in the right measure, eliminating the environmental and health hazards associated with the use of chemical nitrogen fertilizers. It is clear that there is an economic value associated with the use and maintenance of nitrogen fixing bacteria in the environment. This value needs to be estimated and taken into account by the social actors of the decision making process in the agricultural and environmental sectors of all countries.

The benefits of BNF can be, in a way, related to the costs of industrial production as well as transportation of nitrogenous fertilizers to the fields. These costs are reflected in the final price of these fertilizers to the customers, i.e., the farmers. A simplistic method to evaluate the benefits of BNF would be to estimate the amount of biologically fixed nitrogen in a given agro-ecosystem and calculate how much one would spend purchasing and applying the amount of fertilizer that is necessary to make available to plants the same quantity of nitrogen that would have been fixed biologically. In Brazil, soybean is the most successful example of the optimization of the biological nitrogen fixation process applied to acrop. As a result, it is currently the second largest soybean producer and exporter in the world. Furthermore, all production is obtained without the need for additions of nitrogen fertilizers. In addition, one should consider the economic value associated with the higher environmental quality of agricultural systems based on biological nitrogen fixation. It has been estimated that Brazilsaves up to US$ 1.7 billion per year in nitrogenous fertilizers due to theuse of BNF technology in soybeans.

The occurrence of BNF in sugarcane has also been demonstrated. Th ediazotrophs can be both rhizosphere as well as endophytic bacteria. The process of BNF isregulated by the availability of nitrogen in the soil. Centuries of sugarcane exploitation in Brazil underconditions of low-input agriculture led to the selection of sugarcane varieties of high yields and reduced nitrogen requirements. The diversity of diazotrophic bacteria in the tissues of Brazilian sugarcane varieties is significantly greater than that invarieties grown in countries where high levels of nitrogen are applied. The current benefits of sugarcane BNF can be estimated indirectly by the difference in the levels of nitrogen fertilizers applied in Brazil and that applied in other countries. Another potential benefit of BNF toagriculture, particularly in the tropics, derives from the discovery of diazotrophic bacteria in the tissues of a species of palm tree in Brazil . This palm is cultivated mainly in the north east of the country, aiming the extraction of oil, which is used mainly for cooking. The potential of thisoil as a source of automotive fuel has been shown. Environmental benefits should also be converted to monetary values, such as reductions of: 1) nitrate run off to the aquifers, lakes and rivers; 2)nitrogenous gases derived from fertilizers which are volatilized to the atmosphere, and can contribute to greenhouse effects and global warming; 3) air pollution from the fertilizer industry, considering that much more fertilizer than what the plants need must be added to compensate for the losses associated with the application of fertilizers, and that these losses vary according to the crop. Different agricultural management practices result in alter ations in the diversity of microorganisms in the soil. This has been demonstrated for rhizobia in Brazilian soils under no tillage and conventional till age practices in cash crop plantations as well as in conversions of rain forests to subsistence farming. One should put the value of the in situ diversity in monetary terms so that the cost/benefits of the different management options take into account this important asset.

The ex-situ diversity of diazotrophs is represented by the culture collections worldwide that distribute well documented strains of nitrogen fixing bacteria to the users. There are several values and costs associated with culture collections. The ex-situ diversity of nitrogen fixing microorganisms provides genetic material for agronomical, ecological, educational, and scientific purposes. On the other hand, the costs of maintaining culture collections have to be evaluated so that a proper assessment of the cost / benefit relation of the ex-situ diversity of diazotrophs is achieved. Economists should be involved in the molecular ecology research efforts so as to adapt their methodologies and models to the type of data that are being generated. Finally, there is an urgent need to develop models for the economic valuation of this important natural resource, incorporating social concerns and current international market standards, such as ISO 14000 or the green label .

___________________________________________________________



Biodiversity, Bioprospecting and Combinatorial BiomoleculeDiscovery.

Eric Mathur (emathur@diversa.com)

Microorganisms colonize virtually all biotopes found on our planet including geothermal ecosystems and hydrothermal vents, in hyper saline and super cooled sea ice, translucent stones, in the presence of toxic heavy metals and within extremely acidic and alkaline environments. Complex microbial consortia are found in symbiotic associations with marine metazoans, insects, nematodes and in plants, as endophytes. Soils and sediments from tropical to arid regions harbor tremendously diverse communities of microorganisms. Diversa Corporation has devoted significant effort toward globally accessing microbial diversity. Formal access agreements have been signed with Yellowstone National Park, Costa Rica, Iceland and Indonesia. Our bioprospecting program was designed to be consistent with the Rio Declaration and Treaty, currently ratified by over 170 countries worldwide. The framework objectives include conservation of biological diversity, sustainable use of its components and equitable sharing of the benefits. The myriad of microbes inhabiting our biosphere represents a tremendous repository of valuable biocatalysts and bioactive compounds for industrial, agricultural and pharmaceutical applications. Molecular analyses suggest that the vast majority of microorganisms residing in the natural environment remain uncultured.

Diversas discovery program bypasses this limitation bycapturing genes and gene pathways from nucleic acids extracted directly from the environment. This strategy circumvents thetraditional requirement for isolation and cultivation of microbes prior to enzyme or drug discovery efforts. High throughput, automated, recombinant screening systems have yielded over 700 unique enzymes and a collection of novel bioactive molecules. Broadly accessingnatural biomolecular diversity coupled with in vitro directed evolution is the basis for Diver sas technology platform; thus comprising a combinatorial approach for biocatalyst development and recombinant natural product discovery.

___________________________________________________________



Microorganisms and the development of bioindustries in Japan.

S.Sumida (sumida@hi-ho.ne.jp)

The market size of microbial products in Japan is, according to a certain estimate, around 6,500 billion yen in 1997(the value varies, depending on sources). Traditional fermentation products are predominant in monetary terms, but markets for microbial products derived from the applications of modern sciences have been steadily growing since 1950s.This is largely due to discovery of new functions of known substances, innovations in manufacturing processes, discovery of novel lead compounds of microbial origin, etc. Microorganisms are considered to have great potentials for further industrial applications. However, our experiences indicate that realization of these potentials will require ingenuity and intensive research, at both basic and applied levels, on the basis of advances inbiological sciences.Particularly, progress in basic science on microbial diversity seems to be akey to futureinnovations under the current circumstances.








INTERNATIONAL INITIATIVES AND PLANS

The revision of the FAO International Undertaking on PlantGenetic Resources forFood and Agriculture: Present Status and Future Perspectives.

Marcio de Miranda Santos (marcio@sede.embrapa.br)



1- Background information

The International Undertaking was adopted by the FAO Resolution 8/83. It is a non legally-binding agreement signed by 111 countries. This Resolution was complemented by FAO Resolutions 4/89, 5/89 and 3/91 which have introduced the concept of Farmer's Rights and National Sovereignty, in addition to the creation of International Fund to implement Farmer's Rights.

In November of 1993, the FAO conference has adopted the resolution 7/93, calling for there vision of the International Undertaking, to bring it in harmony with the Convention on Biological Diversity.

The revision process is governed by the Commission on Genetic Resources for Food and Agriculture-CGRFA (formerly, Commission on Plant Genetic Resources),created by FAO Resolution 9/83. Presently, 146 countries plus the European Community compose the CGRFA.



2- A summary of the present status of the plant germplasmex-situ collections

There are approximately 6,1 million accessions stored in the ex-situ collections throughout the world, including the roughly 500 thousand accessions kept in field gene banks. These materials are kept in approximately 1300 ex-situ collections. It is estimated that only 35% of these materials are unique (study based on 37 major crops and including 2,5million accessions).

It is estimated that 1500 botanical gardens exist in the world, nearly 700 of which have germplasm collections.

The main difficulties in using plant materials stored in ex-situ collections are:

-
lack of available information (existence, characterization, etc.);

-
difficulty in accessing collections and handling largecollections;

-
difficulty and expense of introducing new material in on-going breeding programs;

-
lack of breeding capacity;

-
small range of species addressed.


3. Main issues at stake

-
The risk of losing access to the genetic variability of the main food crops and jeopardize food security in the long run;

-
To create a complex and bureaucratic multilateral system for the exchange of germplasm, that will not allow the present flow of materials to proceed inan effective way (approximately 600 thousand accessions per year);

-
Threaten the present system of joint conservation of germplasm, especially in relation to the main staple food crops (the risk of trying to go bilateral when one must go multilateral);

-
How properly to address the issue of benefit sharing in a balanced way among providers and users of germplasm and associated knowledge.


4- The present debate

Scope and access

-
To make the revised IU attractive, it is expected that it coversas many food crops as possible. So far, delegations agree that the revised IU relates to plant genetic resources for food and agriculture. There is also a growing consensus that the scope will also be defined by means of a "list (genus/species) of crops". The materials that will be included in the system will be mainly defined according to their importance for the global diet and food security, and the level of genetic resources international inter dependence. Genus/speciesnot included in the list (i.e. some high-value industrial plants) will be handled through bilateral agreements.

Benefit-sharing mechanism

-
Definitely one of the most difficult and sensitive items and the main reason for the abortion of the negotiations at the last Fifth Extra ordinary Session of the CGRFA (June 8-12, 1998).

Main reasons are:

-
delegations were not prepared to enter into the details on the nature of the financial mechanism for benefit sharing (a bill to be paid, according to the South, a contribution (aid) for the implementation of the rolling FAO Plan of Action, according to the North;

-
the belief shared by some countries that the return flow of improved agriculture technology (improved varieties, for example) are the best and most realistic form of benefit sharing;

-
difficulty in assessing the rightful share of providers of germplasm (mainly countries in the South);

-
Practical difficulties in monitoring use of germplasm through time;

-
The sense that a direct charge to the seed industry or a portion of the royalties on plant patents will lead to marginal values. Most probably, the expenses required implementing such a system would surpass the amount destined to an international fund.


Farmer's Rights

Another very controversial issue. Only a few number of countries persist with the FAO "concept" of Farmer's Rights, as stated in FAO resolution ... /.. . On the other hand, most countries advocate that, in whatever form the multi lateral system will take, it must strengthen the rights of farmers to save, exchange and enhance plant genetic resources. The way countries manage intellectual property rights over plant genetic materials and plant varieties makes the difference among extreme positions.

The legal status of the multilateral agreement

Although this issue was never discussed in depth before, most countries seem to favor an intergovernmental-enforceable agreement. There is also a sense that only governments will be members of the multilateral systems.



4- Future Perspectives

All countries from North and South will have hard decisions to make in future negotiations and there is a fear that they will not be able to reach an agreement on most of them (see main items above). There is an urgent need for countries to offer and carefully examine balanced proposals, coming from both sides, on the main issues presented above and find a way to compromise, bearing in mind that a multilateral system for the exchange of plant genetic resources of food crops is directly linked to long term global food security. Negotiations will probably resume at the last week of November 1998 and lets hope for the best. Future generations will judge all of us.

___________________________________________________________



Code of Conduct for Accessing Microbial Genetic Resources (MOSAICC Project).

Phillipe Desmeth

MOSAICC : Elaboration and diffusion of a voluntary Code of Conduct for the access to and sustainable use of microbial resources within the framework of the Convention on Biological Diversity .



The need for international co-operation

Microbial resources are of major interest to the well-being of mankind, both in developed and developing countries, as micro-organisms play a key role by there sustainable use for biotechnological applications in the health sector(production of antibiotics, drugs, vaccines,etc.), agriculture (biofertilisers, biopesticides, post harvest control,...), food (fermented foodsand drinks,...), environment (bioremediation of pollution in water, soil and air,...), energy (bioethanol, biogas,...). Easy access to and international circulation of these microbial resources are in consequence crucial to ensure a sustainable development in the industrial and developing countries.



New principles laid down by the Convention on Biological Diversity

The Convention on Biological Diversity (CBD, Rio de Janeiro, 5 June1992) aims to provide for the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources (CBD article 1). To achieve these goals, the CBD lays down the principles governing, among others, the access to genetic resources (article 15), the access to and transfer of technology (articles16, 18 & 19) and the fair and equitable sharing of benefits (art.15 & 19).



The need for standardised procedures

Since the many microbiologists working in major fields relevant to the sustainable development of mankind (e.g. health, agro-food, environment) and the conservation of the worlds ecosystems must deal with microbial genetic resources (MGRs) from all over the world, there is an urgent need for a code of conduct dealing with these matters in a practical way.

The mission of the MOSAICC-project is to propose and promote such avoluntary code of conduct. This code of conduct is developed to facilitate easy access to and international circulation of Microbial Genetic Resources (MGRs) for the benefit of sciences and world-wide sustainable development in the framework of the Convention on Biological Diversity. This voluntary code of conduct is to represent a consensus obtained between a balanced group of representatives from North and South, as well as representatives from the not-for-profit-sector (e.g. government, culture collections, academics,NGOs) as from the commercial sector (e.g. pharmaceutical, chemical and food industry).

As experienced in the MOSAICC project, the fair and equitable sharing of the benefits necessitates a good knowledge of the value of the MGRs, the goodwill of the respective partners to come to an overall win-win situation aswell as the correct, fair and mutual understanding of each others interests andthe added value of their respective contributions. It implies that the return for each partner should correspond fairly with the time, money and intellectual and inventive effort invested by that partner, including for the maintenance of the MGRs. The Halifax WFCC workshop on the Value of Microbial Diversity can lead to a better valuation of the inputs added along the successive steps (isolation,identification,characterisation,...) that enable the sustainable use of MGRs.



MOSAICC aims:

- to assist microbiologists:

1)
to obtain, according to art. 15.5, Prior Informed Consent agreement, here after termed PIC for access to MGRs;

2)
to establish, according to articles 15.4, 15.6, 15.7, 16, 18 and 19, on the basis of mutually agreed terms, Material Transfer Agreements (MTA) for the access to and the transfer of MGRs, the access to and the transfer of technology (including biotechnology), the fair and equitable sharing of the benefits as well as for technical and scientific co-operation.


- to assist countries providing MGRs (cf. CBD article 15.3):

1)
to issue PICs for access to MGRs;

2)
to track the path and utilisation of such MGRs; and this with a view to enable a fair and equitable sharing of the benefits arising from their utilisation.


To this end MOSAICC includes:

- recommendations to microbiologists and to ex-situ resource centres,

These recommendations should be considered as guidelines for anoptimal implementation of the CBD. National and international legal requirements developed in or outside the framework of the CBD remain compulsory.

- suggestions to countries;

- definitions, model forms and certificates.



MOSAICC is designed to be flexible to deal with:

1)
in-situ and ex-situMGRs;

2)
countries that do have or do not have appointed (an) official competent authority(s) to provide Prior Informed Consent (PIC) to access MGRs within the framework of the CBD;

3)
providers and recipients of MGRs from diverse backgrounds;

4)
issues relating to the unique properties and the wide range of applications of MGRs.

MOSAICC fully respects that individual countries retain their ownspecial interests and goals,even if this involves definitions and rules that go beyond those laid down by the CBD.



MOSAICC maintains, however, that:

-
a uniform set of definitions and guidelines could be more economic and effective to implement the principles of the CBD and tend to the objectives of the CBD;

-
the success of countries in co-operating with other countries and in economically and sustainably exploiting their microbial biological diversity will depend inevitably on the degree of practicability and the feasibility of the national regulations and procedures that these countries impose;

-
access to MGRs is a prerequisite condition for the sharing of any potential benefits.

MOSAICC can also serve as a reference when dealing with genetic resources other than MGRs.

Finally it is important to emphasise that MOSAICC is aconcerted action between the following partners:

OECD - Organisation for Economic Co-operation and Development (France)

Biotechnology Unit, Directorate of Science, Technology and Industry

IUCN - World Conservation Union, Environmental Law Centre (Germany)

The Royal Botanic Gardens KEW, Herbarium, Conventions and PolicySection (UK)

Novo Nordisk A/S, Department of External Relations (Denmark)

IMI - International Mycological Institute, Department of Mycology(UK)

WFCC - World Federation for Culture Collections, WFCC -Biodiversity Committee (UK)

IPM - Industrial Platform for Microbiology (Belgium)

Fundacao Tropical Andre Tosello, Colecao de Culturas Tropical(Brazil)

INBio - Instituto Nacional de Biodiversidad, Department of Bioprospection (Costa Rica)

Universitas Indonesia Culture Collection, Laboratory of Microbiology (Indonesia)

Agricultural Research Council, Plant Protection Research Institute (Republic of South-Africa)

Coordination: Office for Scientific, Technical and Cultural Affairs (Belgium)

Belgian Coordinated Collections of Micro-organisms BCCM

___________________________________________________________



An international resource for information on ex-situ microbial collections.

Hideaki Sugawara (hsugawar@genes.nig.ac.jp)



1. WDCM

At a UNESCO meeting in 1966 the Japanese Federation for Culture Collections proposed the establishment of a data center of culture collections and the proposal was welcomed by the international scientific community. The World Data Centre for Microorganisms(WDCM) was initially set up by Prof.V.B.D.Skerman at the University of Queensland in Australia. In 1986, the World Federation for Culture Collections (WFCC) agreed to relocate the center to the Institute of Physical and Chemical Research (RIKEN:RIKAGAKU-KENKYUUSHO in Japanese) based on the evaluation of proposals from several institutions.

After the relocation, the WDC published:

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World Catalogue of Algae in 1989

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Guide to World Data Center on Microorganisms with a List of Culture Collections in the World in 1989

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World Directory of Collections of Cultures of Microorganisms (4th edition) in 1993.

During this time, the acronym was changed to WDCM to stress that it is a data center on microorganisms and the director of WDCM changed from Professor Kazuo KOMAGATA to Professor Hideaki SUGAWARA. In 1997, the centre was further transferred to the National Institute of Genetics (NIG) in Japan, based on the agreement of RIKEN, NIG,the Japan Society for Culture Collections and World Federation for Culture Collections.

The URL of the WDCM web page now is http://wdcm.nig.ac.jp/ , where the 498 microbial culture collections in 55 countries and their holdings can be searched.



2. WDCM symposium

The WDCM web site started functioning at NIG in April 1997 and the WFCC web pages have since been developed further. In the meantime, the director of WDCM visited several major culture collections in the USA and Europe and, as a result, felt that an international symposium to study the activities of ex situ microbial resource centres would be an important activity. It was clear that meeting the needs of such mega-science projects as biodiversity conservation or genome projects required cooperation among the centres, since none could support the requirements alone. Therefore, he has organized a WDCM symposium on February 16th, 1998 in Tokyo to discuss the cooperation of culture collections worldwide towards collaborative activities to meet the demands of the 21st century. This will precede a workshop on Biological Resources Centers (BRCs) organized by the OECD Working Party for Biotechnology (WPB).

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