United Nations

E/CN.17/1995/20


Economic and Social Council

 Distr. GENERAL
3 March 1995
ORIGINAL: ENGLISH


COMMISSION ON SUSTAINABLE DEVELOPMENT
Third session
11-28 April 1995


             EDUCATION, SCIENCE, TRANSFER OF ENVIRONMENTALLY SOUND
                TECHNOLOGIES, COOPERATION AND CAPACITY-BUILDING

               Environmentally sound management of biotechnology

                        Report of the Secretary-General

                                     SUMMARY

      An overview of the progress made, the problems encountered and the
lessons learned, and priority issues for further consideration, with respect
to chapter 16 of Agenda 21, 1/ are discussed in the present report.

      Chapter 16 focuses upon the need for (a) increasing the availability of
food, feed and renewable raw materials; (b) improving human health;
(c) enhancing protection of the environment; (d) enhancing safety and
developing international mechanisms for cooperation; and (e) establishing
enabling mechanisms for the development and the environmentally sound
application of biotechnology.

      This report is based on a thorough analysis of information obtained from
a wide range of sources, including Governments, the United Nations and other
intergovernmental organizations, non-governmental organizations, the
scientific and academic communities, the business community, donors, and
others.

      This report presents several proposals on which the Commission on
Sustainable Development is invited to take action in order to support and
initiate activities at the national level and promote international
cooperation.  The proposals emphasize the key role of the private sector in
contributing to sustainable development, and the need for close cooperation
with the Convention on Biological Diversity 2/ on the issue of biosafety.


                                   CONTENTS

                                                            Paragraphs  Page

INTRODUCTION................................................   1 - 5       4

  I.  BIOTECHNOLOGY AND SUSTAINABLE DEVELOPMENT:  A GENERAL 
      OVERVIEW..............................................   6 - 8       5

 II.  ASSESSMENT OF PROGRESS ACHIEVED AND EXPERIENCES.......   9 - 56      6

      A.  Country experiences...............................  12 - 21      7

          1.  Developing countries..........................  12 - 16      7

          2.  Developed countries...........................  17 - 19      9

          3.  Transitional economies........................  20 - 21     10

      B.  Experiences of major groups and non-governmental
          organizations.....................................  22 - 25     10

      C.  Matters related to finance........................  26 - 33     11

      D.  Recent developments and experiences in
          international cooperation.........................  34 - 56     14

          1.  Programme area A:  Increasing the availability
              of food, feed and renewable raw materials.....  35 - 37     14

          2.  Programme area B:  Improving human health.....  38 - 42     15

          3.  Programme area C:  Enhancing protection of the
              environment...................................  43 - 47     16

          4.  Programme area D:  Enhancing safety and
              developing international mechanisms for
              cooperation...................................  48 - 50     17

          5.  Programme area E:  Establishing enabling
              mechanisms for the development and the 
              environmentally sound application of 
              biotechnology.................................  51 - 56     18

III.  GENERAL LESSONS LEARNED...............................  57 - 60     19

 IV.  CONCLUSIONS AND PRIORITY ISSUES FOR FURTHER
      CONSIDERATION.........................................  61 - 78     21

      A.  Conclusions.......................................  61 - 71     21

      B.  Priority issues...................................  72 - 78     23
                                                             
          1.  The key role of the private sector - business,
              industry and the banks - in promoting and
              applying biotechnology for sustainable 
              development to meet the objectives of 
              chapter 16....................................      73      23

          2.  The need to integrate biotechnology concerns
              into national sustainable development policies
              for making and building national capacities...      74      24

          3.  The need to achieve and demonstrate safe and 
              viable results for sustainable development in
              the application of biotechnology..............      75      24

          4.  Safety in biotechnology.......................      76      25

          5.  Matters related to intellectual property rights     77      25

          6.  The need to promote greater awareness of 
              biotechnology issues..........................      78      25

  V.  PROPOSALS FOR ACTION..................................      79      25

                                    Annexes

  I.  UNITED NATIONS SYSTEM AND INTERNATIONAL ORGANIZATION
      ACTIVITIES IN SUPPORT OF CHAPTER 16 OF AGENDA 21:
      ENVIRONMENTALLY SOUND MANAGEMENT OF BIOTECHNOLOGY ................  29

 II.  ADDITIONAL SOURCES OF INFORMATION ................................  43


                                 INTRODUCTION


1.   Agenda 21 1/ addresses many pressing issues, including the concept of
sustainable development, and focuses on addressing the challenges of the next
century.  It calls for a number of interrelated programmes to be carried out
by various key players according to the different capacities, situations and
priorities of countries and taking into account the principles contained in
the Rio Declaration on Environment and Development. 3/

2.   Chapter 16 of Agenda 21, on the environmentally sound management of
biotechnology, focuses upon the need for (a) increasing the availability of
food, feed and renewable raw materials, (b) improving human health,
(c) enhancing protection of the environment, (d) enhancing safety and
developing international mechanisms for cooperation and (e) establishing
enabling mechanisms for the development and the environmentally sound
application of biotechnology.  These five programme areas seek to foster
internationally agreed upon principles to be applied to ensure the
environmentally sound management of biotechnology, to engender public trust
and confidence, to promote the development of sustainable applications of
biotechnology and to establish appropriate enabling mechanisms to achieve
those objectives.

3.   Many of the issues discussed in chapter 16 are also reflected in other
chapters of Agenda 21.  Recognized as a cross-sectoral issue, biotechnology is
linked particularly to the issues set out in chapter 6 (Protecting and
promoting human health), chapter 11 (Combating deforestation), chapter 14
(Promoting sustainable agriculture and rural development), chapter 15
(Conservation of biological diversity), chapter 17 (Protection of the oceans,
all kinds of seas, including enclosed and semi-enclosed seas, and coastal
areas and the protection, rational use and development of their living
resources), chapter 18 (Protection of the quality and supply of freshwater
resources:  application of integrated approaches to the development,
management and use of water resources) and chapter 21 (Environmentally sound
management of solid wastes and sewage-related issues).

4.   Agenda 21 calls upon all organizations of the United Nations system to
play a key and active role in assisting Governments to establish more
effective patterns of balanced economic and social development with minimal
negative impacts to the environment.  The United Nations Industrial
Development Organization (UNIDO), designated by the Inter-Agency Committee on
Sustainable Development as the task manager for chapter 16, is responsible for
the preparation of the present consolidated report on the implementation of
the programme on the environmentally sound management of biotechnology.

5.   In the preparation of this report, an inter-agency consultation was held
to provide a forum for deliberation on strategic issues and to discuss
innovative measures to address these issues.  An informal inter-sessional
consultative group of Governments was also briefed on the preparatory process.

Significant contributions by the various United Nations and other
international bodies were made prior to, during and, in response to the draft
reports, after consultation.  In addition, extensive use was made of inputs
from national reports as well as reports from intergovernmental bodies,
notably the Organisation for Economic Cooperation and Development (OECD), in
reviewing developments and trends in biotechnology.  Furthermore, special
attempts were made to solicit inputs from the private sector, the
non-governmental organization community and women's organizations in order to
include balanced perspectives in the final consolidated report.


      I.  BIOTECHNOLOGY AND SUSTAINABLE DEVELOPMENT:  A GENERAL OVERVIEW

6.   Biotechnology is broadly defined to include any technique that uses
living organisms or parts of organisms to make or modify products, to improve
plants or animals, or to develop microorganisms for specific use.  It ranges
from traditional to the most advanced modern biotechnology.  Commercial
biotechnology consists of an expanding range of interrelated techniques,
procedures and processes for practical applications in the health care,
agricultural and industrial sectors.  Commercialization of biotechnology
ranges from research to products and services.  The technologies concerned are
powerful ones, supported by complementary bioprocess engineering to help
translate new discoveries of the life sciences into practical products and
services.  As such, biotechnology should also be seen as an integration of the
new techniques emerging from modern biotechnology with the well-established
approaches of traditional biotechnology, such as plant breeding, food
fermentation and composting.

7.   The concept of sustainable development is based on the conviction that
it should be possible to increase the basic standard of living of the world's
growing population without unnecessarily depleting our finite natural
resources and further degrading the environment in which we live.  Emerging
biotechnologies, based on new scientific discoveries, offer novel approaches
for striking a balance between development needs and environmental
conservation.  A wider diffusion of such technology is seen as the key to
directing its positive impacts towards world society as a whole. 
Biotechnology is developing  continuously and rapidly in an increasing number
of sectors that improve the effectiveness of the way in which products and
services are provided.  However, the transfer and development of biotechnology
in an environmentally sound manner requires a variety of conditions, including
capital inputs which, in the case of many developing countries, are not
readily available.

8.   All countries require appropriate infrastructures that permit them to
acquire, absorb and develop technology, to manage it properly and
systematically, and to build up local scientific and technological competence.

The resultant ability of any country, and of a developing country in
particular, to discern, choose and adopt an environmentally sound emerging
biotechnology can serve as a measurement of sustainable self-reliance that
will allow it to participate fully in world-wide efforts to achieve
sustainable development.  The creation of enabling conditions poses new
challenges that must be addressed in order for developing countries to realize
the potential benefits of biotechnology and minimize any possible adverse
socio-economic or environmental effects.


             II.  ASSESSMENT OF PROGRESS ACHIEVED AND EXPERIENCES

9.   Since the United Nations Conference on Environment and Development,
considerable progress has been achieved in raising awareness, particularly
among the scientific community, policy makers and, to a lesser extent, the
general public, of the potential benefits and risks, and the need for
environmentally sound management, of biotechnology.  As a result, it is now
widely recognized that biotechnology can play an essential role in fostering
the economic and social development of both developed and developing
countries, if properly managed.  Biotechnology development and applications
have continued to grow at a very rapid rate, leading to an expanding range
across several sectors of products and processes that began with
pharmaceuticals and health care, and was extended to agriculture and, more
recently, to the environment.  In the area of health, many biotechnological
products, such as insulin, diagnostics and vaccines, have already been placed
on the market and products such as recombinant-derived hepatitis B vaccine
have gained widespread international use.  Two new biotechnology-based cholera
vaccines have recently been licensed in some countries.  Currently, more than
2,000 clinical trials of biotechnology-related products are in progress,
mainly in the more biotechnologically advanced countries.  In agriculture,
products such as diagnostics, biopesticides and bovine growth hormone have
been in commercial use.  Other products and technologies being developed
include improved seeds, new vaccines, novel food ingredients,
biotechnology-based techniques for the rapid detection and identification of
toxic materials, and several bioprocessing technologies.  Developed countries,
having increasingly privatized biotechnology research and development,
continue to forge ahead rapidly in many sectors.  From a global perspective,
it has been forecast that major impacts can be expected on health,
pharmaceuticals, agriculture, food and the environment within the next 20
years.

10.  Several United Nations organizations, in cooperation with the regional
commissions, have continued to strengthen their biotechnology and related
support programmes and to develop new biotechnology initiatives to assist
developing countries and countries in transitional economies, with the result
that several developing countries are now giving high priority or increasing
attention to biotechnology development.  Through these and other multilateral
and bilateral programmes, many applications of biotechnology have been made
appropriate and accessible to developing countries.  The tendency of most
developing countries is to acquire biotechnologies aimed at improving
agriculture, and food and pharmaceutical production, and converting low-cost
or marginalized raw materials into high-value-added products and marginalized
lands into more productive areas.  Technologies such as biofertilizers, tissue
culture, vaccines, and some new diagnostics that can be utilized despite
relatively low levels of resources and technological capacity are currently
available for immediate transfer and applications to developing countries.  In
fact, these technologies, especially biofertilizers and bio-insecticides, are
gradually being used in several countries around the world to increase crop
yield and reduce agrochemical inputs.  In addition to the appropriate use of
traditional and intermediate biotechnologies, an increasing number of
developing countries are seeking to integrate more advanced biotechnologies
into national development plans and programmes, either as part of the relevant
traditional sectors or as new biotechnology programmes.  Some biotechnologies
appropriate to and required by developing countries are, however, proprietary
in nature.  As such, biotechnological solutions in developing countries need
to be assessed and selected on the basis of priority and efficacy.  New and
additional management skills are needed to assist these processes.

11.  With regard to the progress in enhancing safety and developing
international mechanisms for cooperation, significant progress in regional
consultation and cooperation has been made, building on the previous
experience of the UNIDO/United Nations Environment Programme (UNEP)/World
Health Organization (WHO)/Food and Agriculture Organization of the United
Nations (FAO) Informal Working Group on Biosafety and other more recent
international initiatives such as the International Service for National
Agricultural Research/International Biotechnology Service (ISNAR/IBS), the
International Service for the Acquisition of Agri-Biotech Applications (ISAAA)
and the Agricultural Biotechnology for Sustainable Productivity (ABSP) project
and, in particular, the Biotechnology Advisory Commission of the Stockholm
Environment Institute.  The Convention on Biological Diversity 2/ is in the
process of considering the need for and modalities of a possible protocol on
biosafety under the Convention.  A further important initiative is also under
way under the auspices of UNEP to develop further draft international
technical guidelines on safety in biotechnology, jointly prepared by the
Governments of the United Kingdom of Great Britain and Northern Ireland and
the Netherlands.  The recent launching of the Biosafety Information Network
and Advisory Service (BINAS) within the United Nations system, as recommended
by the UNIDO/UNEP/WHO/FAO Informal Working Group on Biosafety, encouraged an
increasing number of developing countries to participate as national focal
points and to cooperate within the regions to establish regional nodes and
networks.  At the present time, the absence of established biosafety
procedures in developing countries constitutes a major constraint to field
testing - and, indeed, to product development - by those international public
sector initiatives designed to facilitate the introduction of biotechnology
into developing-country agriculture.


                            A.  Country experiences

                            1.  Developing countries

12.  With respect to the level of biotechnology development and applications,
there is a great variation among developing countries.  More technologically
advanced developing countries, such as China, India, the Republic of Korea and
Singapore in Asia, and Brazil and Cuba in Latin America and the Caribbean,
have set biotechnology as a high priority for development.  Most of these
countries have invested significantly in infrastructure and human resource
development and have increasingly encouraged foreign investment.  The result
has been the establishment of biotechnology-based enterprises, mainly
fermentation-industry and pharmaceutical products in the regions.  Modern
biotechnology research programmes have also steadily increased, especially in
agricultural sectors such as biofertilizers, biopesticides and virus-free
seedlings, including various aspects of tissue cultures.  Biotechnology
applications in developing countries range from the use of advanced
biotechnological techniques, as, for example, in the production of transgenic
crops and artificial seeds in China, and in the production of several
pharmaceutical products in Cuba and the Republic of Korea, to the use of
traditional and intermediate biotechnologies in food fermentation and nitrogen
fixation in less advanced countries.  Several countries in the Middle East
have emphasized the importance of biotechnology in developing stress-tolerant
agriculture and in bioremediation.

13.  In African countries, the level of sophistication in biotechnology
development is extremely variable, ranging from very traditional applications
such as food fermentation of cassava in least developed countries, to
monoclonal antibody and diagnostics research and tissue cultures in other
countries.  Egypt, Kenya, Nigeria, Zimbabwe and South Africa are among the
leading countries in this area in the region.  In general, biotechnology
research and development in Africa evolves around the various international
research and development centres, as, for example, the International Institute
for Tropical Agriculture in Nigeria and the International Centre for Insect
Physiology and Ecology in Kenya.  Egypt and South Africa have, in particular,
given high priority to biotechnology in the countries' development planning,
especially in relation to infrastructural support and human resource
development.

14.  The development and applications of biotechnology in developing
countries continue to be heavily dependent on investment by the public sector,
even though private sector foreign investment in biotechnology has gradually
increased.  A meeting in 1994 of biotechnology managers from more than 40
developing countries, mostly members of the International Centre for Genetic
Engineering and Biotechnology (ICGEB), to explore emerging biotechnologies and
industrial opportunities revealed that the understanding and appreciation of
local entrepreneurs with regard to the economic potential of the biotechnology
industry are still very low.  On the other hand, awareness regarding biosafety
and the urgent necessity for the environmentally sound management of
biotechnology among the biology-related scientific community is relatively
high compared with awareness in the non-biology-related scientific community. 
Among the more than 60 countries that have benefited from the UNEP/UNIDO/ICGEB
biosafety training workshops, fewer than 20 per cent have developed biosafety
guidelines or established national regulatory mechanisms for addressing the
biosafety regulation issue.  A number of countries have begun the process of
developing a database (national node) on biosafety as well as a national
regulatory machinery to ensure the environmentally sound management of
emerging biotechnologies.  Concerning the issue of intellectual property
rights protection, most countries are well aware of the importance of
intellectual property rights in general, but have inadequate knowledge and
capacity to address effectively the issues relating to life forms and related
implications of the trade-related aspects of intellectual property rights
(TRIPS) Agreement concerning intellectual property rights in relation to
biotechnology.  In this connection, the Government of India, in cooperation
with the World Intellectual Property Organization (WIPO), hosted an
international meeting in 1994 on the role of patents in biotechnological
inventions, emphasizing the need to strengthen the information system in this
area.

15.  Case-studies on biotechnology and sustainable agriculture recently
commissioned by the OECD Development Centre for Kenya and Zimbabwe in Africa,
India and Thailand in Asia, and Colombia (and Mexico) in Latin America
identified common constraints in the diffusion of environmentally sound
biotechnologies, especially to small farmers, weak collaboration between the
private and the public sectors, and inadequate financial resources as well as
mechanisms for the effective exploitation of emerging technologies.  A number
of major breakthroughs in crop, animal and forestry research and development
have been noted.  In countries where legal frameworks for biosafety and/or
intellectual property protection are in place, the operational aspects need
further attention. 

16.  Although there is inadequate information on the current state of
development and on the immediate economic impact of biotechnology in many
other developing countries, mainly because in most of the developing countries
biotechnology is integrated into the various traditional sectors, the general
trend appears to be positive.  It is reasonable to say that the economic
impact of biotechnology in a given country is in close correlation with the
biotechnology capacity and related investment of that country.  In this
respect, there is a need for more effective indicators on progress towards
sustainable development through biotechnology.


                            2.  Developed countries

17.  Developed countries, particularly the United States of America, Japan
and several countries in Europe, have had long experience in the development
and applications of biotechnology, especially the new biotechnology.  Numerous
studies and reports, prepared by individual countries and by OECD in
particular, on the various aspects of biotechnology development and
management, provided a useful background in understanding the evolution and
trend of biotechnology development.  Improved and innovative institutional,
legal and financial arrangements relating to private sector collaboration,
university-industry linkage, strategic business alliances and venture capital
have been extensively developed to address the emerging issues relating to new
biotechnology.  Of particular interest is the database on biosafety maintained
by OECD.  Furthermore, additional mechanisms continue to be developed to
address the issues of public perception and education with respect to
bioethics, including the European Federation for Biotechnology's Task Group on
Public Perceptions of Biotechnology, the Gen Suisse Foundation for public
information on biotechnology and, in the United States, the Union of Concerned
Scientists.

18.  In most developed countries many biotechnological products and services
have already been placed on the market and are widely used, especially those
in the pharmaceutical sector.  Currently more than 1,700 clinical trials and
1,000 field tests are in progress.  Successful development and utilization of
biotechnologies include, inter alia, the application of a recombinant rabies
vaccine in dealing with the problem of rabies in wild animals and in situ
bioremediation of contaminated soil.  More recent experience, in the United
States, involves the shift towards increasing public acceptance of the
development and use of biotechnology-based growth hormone for increasing milk
yield and the genetically engineered tomato.  Similarly, the pressure to
decrease dependency on chemical pesticides is expected to drive the growth of
biopesticide production and use, estimated to reach US$ 150 million in the
United States alone as compared with the US$ 6.8 billion for conventional
pesticides.

19.  A recent development initiative in Mexico, conceived as a collaborative
arrangement between the business sector, a national Government, and the United
Nations and international organizations to promote the environmentally sound
management of biotechnology, involves an experimental effort to increase the
yield of tropical maize.  A combination of classical plant biotechnology and
advanced genetic engineering techniques involving gene-encoding toxins that
are lethal to maize insects is being used to produce pest-tolerant tropical
maize.  The development of appropriate protocols will be part of such an
effort, which can be expanded to include other crops and products.


                          3.  Transitional economies

20.  The transitional economies present a case for special attention in their
potential role and contribution to the global efforts in the environmentally
sound management of biotechnology.  Supported by a relatively strong
foundation in science and technology and a critical mass of skilled human
resources in the field of biological sciences, many countries, especially
those in Central and Eastern Europe, can, with appropriate and timely support
from the international community, move forward rapidly in biotechnology
development and its safe applications.

21.  Major constraints being experienced by the countries include, in
particular, a drastic decline in financial resources to adequately maintain
the various valuable scientific and technological infrastructures and, of
increasing concern, the critical reduction in the scientific workforce in
bioscience and biotechnology.  Current efforts to revitalize biotechnology and
foster cooperation include the preparation in the Russian Federation of a new
State Programme for the Development of Biotechnology During the Period 1994-
2000, focusing on bio-industrial development and promotion such as through
microbial biomass protein production for food and pharmaceuticals under a more
favourable policy environment.  Others include the joint Russian-Hungarian
initiative to establish a commercially viable sturgeon (fish) gene bank to
support a sustainable marine and aquaculture industry and, more recently, the
establishment of a regional Task Force of Regulatory Oversight in
Biotechnology for Central and Eastern Europe.


                        B.  Experiences of major groups and
                            non-governmental organizations

22.  Non-governmental organizations participated actively in the United
Nations Conference on Environment and Development process.  Their role -
jointly with United Nations bodies - was critical in raising awareness of the
need for safe handling of biotechnology and the conservation of biological
diversity along with the sustainable use of biological resources.  The many
meetings, workshops and forums organized by them provided platforms for a
better understanding of the issues and linkages between biotechnology and
other sectoral and cross-sectoral issues of Agenda 21.  Many non-governmental
organizations emphasize the role of indigenous people and their communities in
the uses of biotechnology as well as in its development.  National and
international scientific organizations dealing with biosciences and
biotechnology are particularly active in promoting biotechnology at various
levels.  Several recent United Nations and bilateral initiatives to promote
biotechnology among farming communities, indigenous people and
micro-enterprises have benefited from non-governmental organizations'
participation in extending their services beyond the traditional government
counterpart organizations and in sharing experiences encouraging people's
participation in the development efforts.

23.  Biotechnology-related industrial associations play a key role in
promoting biotechnology development and transfer.  The Senior Advisory Group
on Biotechnology (SAGB) in Europe is concerned with biotechnology-related
policy issues, including biosafety and intellectual property rights; it is
actively involved in industrial consultation with UNIDO on
biotechnology-related matters.  The Japan Bioindustry Association (JBA) plays
an active role in conducting training courses in bio-industries, an integral
part of JBA's technical cooperation support for developing countries.  SAGB,
JBA and their North American counterparts form an International Biotechnology
Forum (IBF) that is active in promoting biotechnology cooperation and
development internationally and in their respective regions.  These
organizations have contributed significantly to presenting the perspectives on
biotechnology-related issues at international consultations and meetings.

24.  The role of the non-governmental organization community and of citizen
groups is increasingly being recognized - with some encouraging results.  A
joint initiative of the International Organization of Consumers Unions (IOCU)
and the Genetic Resources Action International (GRAIN) in producing a Citizens
Action Resource Guide on Biotechnology and Third World Agriculture to provide
a constructive foundation for future planning for sustainable development is
just one example of this.

25.  The broad range of non-governmental organizations, people's
organizations and consumer groups can provide a useful and complementary
function in the development of environmentally sound applications of
biotechnology, by helping to facilitate the diffusion of information about and
public acceptance of biotechnology.  In this connection, it is noted that
biosafety and biotechnology are subjects to be presented by the Once and
Future Action Network (OFAN) at the NGO Forum to be held as part of the Fourth
World Conference on Women in Beijing, China, in September 1995; the
presentation will focus on women's role in science and biotechnology, linking
it simultaneously to people, the environment, and sustainable development.


                        C.  Matters related to finance

26.  The implementation of the various programmes of Agenda 21 will require
the provision of substantial new and additional financial resources to
developing countries to supplement financing from those countries' own public
and private sectors.  

27.  The total annual requirement for financial resources from the
international community for the period 1993-2000 was estimated by the United
Nations Conference on Environment and Development secretariat to be
US$ 197 million for the five programme areas.  Needs are greatest in the area
of human health, at US$ 130 million, followed by US$ 50 million for
agricultural improvement.  However, the overall total financial cost from all
sources was estimated at US$ 20 billion per year during the same period.  The
cost estimates for biosafety (programme area D) and endogenous capacity-
building (programme area E) were much lower, at US$ 2 million and US$ 5
million respectively, and based on support to be provided by the international
community alone.

28.  Most developing countries are well aware of the potential of
biotechnology to foster economic growth and many countries have identified
biotechnology as a key area for development.  However, basic and applied
research activities in biotechnology are confined primarily to the
universities and are fragmented.  Demand for practical goal-oriented,
multidisciplinary research and development is largely beyond the technical and
financial resources available to the public-funded scientific sector.  With
the exception of the more advanced developing countries, finance for
meaningful biotechnology research and development comes from external sources,
with the private business sector providing only a minimal proportion of the
total.

29.  No comprehensive international survey of financial expenditure for
biotechnology programmes to address the challenges outlined in chapter 16 of
Agenda 21 is currently available.  However, a 1993 survey on international
initiatives in agricultural biotechnology conducted by Intermediary
Biotechnology Services indicated that bilateral and multilateral aid agencies,
international organizations, private foundations, universities and commercial
companies and national Governments were all involved in the financing of
international biotechnology initiatives for developing countries.  It was
revealed that since 1985, the contribution in grant funds had amounted to more
than US$ 260 million, as against World Bank loans and credits for national
agricultural research and development in developing countries of about
US$ 150 million.  It was also clear that compared with biotechnology research
and development in industrialized countries, the amount of finance devoted to
international biotechnology initiatives is far from adequate.  The survey also
provided an interesting profile of financial sources.  It indicated the
significant contribution made by non-profit organizations (foundations) and
bilateral donors and the comparatively small contribution by the private
business sector to the development of biotechnology in developing countries.

30.  The active contribution and participation of non-profit organizations in
biotechnology development is especially important in view of the social
implications of biotechnology and the concerns about equity on the part of
developing countries.  In addition to the Rockefeller Foundation, which had
reportedly contributed more than US$ 50 million since 1985 to the
International Rice Biotechnology Programme alone, biotechnology support
activities of other non-profit foundations should also be noted.  The Biofocus
Foundation in Sweden and the M. S. Swaminathan Foundation in India are
examples of social organizations created to help in directing the benefits of
biotechnology towards less privileged target groups in developing countries.

31.  Bilateral donors and related bilateral cooperative programmes in
biotechnology have been instrumental in strengthening the biotechnological
capability and capacity of developing countries.  Many developed countries
such as Australia, France, Germany, Japan, the Netherlands, the United Kingdom
and the United States have actively supported biotechnology programmes,
including collaborative research and training, and, more recently,
commercialization efforts.  In addition to the financial contribution through
the conventional Official Development Assistance Programme, other channels for
funding have also been created.  Examples include the fellowship programme of
the Japanese Society for the Promotion of Science (JSPS), which has been
carrying out special bilateral exchange programmes between universities in
Japan and those in several South-East Asian countries, the joint United
States-Thailand Company-Directed Research Grants, the Crawford Fund for
International Agricultural Research and, of particular interest, financial
assistance of the International Fund for Agricultural Development (IFAD) to
the least developed countries for agricultural and food development through
biotechnology.

32.  Important lessons learned from these assistance/cooperation programmes
include the following:

     (a)  Long-term commitment is vital to achieving sustainable capacity-
building and to enabling a country to reach a critical level in self-reliance
for further biotechnological development.  The Indo-Swiss project in operation
since its initiation in 1974 has led to pilot commercial production of
biopesticides in India;

     (b)  A networking arrangement among institutions within the country and
region is one of the most cost-effective means to maximize limited resources;

     (c)  Access to or provision of modern scientific equipment and key
biomaterials for research are important components of successful and equitable
strategies for collaborative research;

     (d)  Most important, the financial commitment of the developing/recipient
country Government is critical to successful collaboration.  This commitment
can include in-kind contributions.

33.  Currently, financial contributions from the private sector for
commercial biotechnology development are still relatively low, owing mainly to
the high business risk involved with modern biotechnology enterprises, but
also because of an unfavourable policy environment.  Nevertheless, experience
from developed countries indicates the importance of the private sector's
participation.  In view of the relatively high risk associated with
biotechnology product development and commercialization, more risk capital
needs to be found.  Strategic alliances have been particularly successful
between United States and European companies and between United States and
Japanese firms.  Such alliances are also known to have been formed with and
within developing countries, and although by no means common in biotechnology
development, they are nevertheless being promoted by a number of international
programmes and venture capital firms.  In the developing countries, one
alternative approach being increasingly adopted to promote biotechnology
development and commercialization is that where the private sector forms
partnerships with the governmental enabling institutions, notably science and
technology parks.  Venture capital funds, such as the Transtech Venture Fund
in Singapore, are few as yet but they can nevertheless serve as successful
models not only for fund mobilization from banking institutions and industrial
subscribers, but also - and more importantly - in terms of the modalities for
financing such operations.  The Transtech Venture Fund operates, for example,
both within and outside the country, placing investments in overseas
technology companies providing access to technology as well as related
technology and management support.


     D.  Recent developments and experiences in international cooperation

34.  Since the United Nations Conference on Environment and Development much
work has been done by United Nations system organizations in support of
chapter 16:  Environmentally sound management of biotechnology of Agenda 21. 
A comprehensive review of these activities is given in annex I.

1.   Programme area A:  Increasing the availability of food, feed and
     renewable raw materials

35.  The challenge of meeting the accelerating demands of a growing global
population lies not only in increasing food production and increasing the
nutritional content of the food produced, but also in significantly improving
food distribution systems.  Efforts to meet this challenge will increasingly
be through the successful and environmentally safe applications of
biotechnology in agriculture.  Most of the investment in biotechnology has
been in the industrialized world, yet international organizations are
supporting significant new efforts to introduce modern biotechnology and apply
it so as to improve agricultural productivity and increase food production
without damaging the environment.  FAO, the leading United Nations body in
agricultural biotechnology, along with the Joint International Atomic Energy
Agency (IAEA)/FAO Division of Nuclear Techniques in Food and Agriculture and
other United Nations and international agricultural organizations, is
promoting the applications of biotechnology in agriculture and presently
assisting developing countries in the uses of advanced but relatively
conventional biotechnology for increased yield and quality of food and feed
crops, cash crops and livestock through the formulation and implementation of
specific projects and through research and information networks.  Research is
under way on agricultural crops using modern biotechnology techniques.  These
crops will soon be available in many developing countries.  Evidence from
different countries indicates that advanced agricultural biotechnologies could
be helpful to impoverished farming communities as well as environment-
friendly.  That they are more adaptable than mechanical innovations and green
revolution technology makes them more accessible to small producers.  These
biotechnologies can reduce farmers' dependency on environmentally degrading
agrochemicals while decreasing crop losses.

36.  Important agricultural biotechnology networks have been established to
disseminate information to and training within developing countries.  Among
these are the Plant Biotechnology Network (REDBIO) Cassava Biotechnology
Network and the UNDP/FAO/UNIDO Farmer-Centred Agricultural Resource Management
(FARM) programme, which has a subprogramme on biotechnology and biodiversity,
the aims of which are to promote information-sharing and undertake technology
assessment on the potential of new biotechnologies to contribute to the
characterization of biodiversity.  The various international agricultural
research institutes have major research programmes to increase the yield of
major crops through the study of plant stress resistance, tolerance to
herbicides and resistance to some specific pests and toxins, and through the
study of lignin biodegradation aimed at the recycling of vegetal wastes as
feed stock.  Research programmes extend beyond the host countries to many of
their cooperating partners/network members.

37.  Tissue culture and artificial-seed biotechnologies are contributing
significantly to agricultural productivity gains in Asia and, gradually, in
Africa, and to the forestation of marginal lands in China.  In addition to the
World Bank's support to biotechnology in agriculture and health, new
initiatives by regional and other financial institutions, such as the Asian
Development Bank's support for rice biotechnology, and the Islamic Development
Bank's support for biosaline agricultural research, are encouraging.  Recent
initiatives such as the ABSP project provide an example of an integrated
approach to the transfer of advanced agricultural biotechnology to developing
countries in its inclusion of separate components involving research,
biosafety, intellectual property and global networking efforts.

2.  Programme area B:  Improving human health

38.  A critical objective of development is to foster human health. 
Increasing levels of environmental degradation compounded by poor and
inadequate development continue to impact negatively on human populations. 
International organizations have increasingly important contributions to make
in the use of biotechnology to combat major communicable diseases, in the
promoting of good health, in improved programmes for treatment of and
protection from major non-communicable diseases, and in the developing of
appropriate safety procedures.  Biotechnology products in health care are now
fairly widespread.

39.  Although conventional approaches have been highly successful in the
development of vaccines against many infectious diseases, they have failed to
produce efficient vaccines against some of the most important ones such as
malaria, diarrhoeal diseases and human immunodeficiency virus (HIV).  The
recrudescence of infectious diseases has also given rise to health-care
concerns in the developed countries in recent years.  Deoxyribonucleic acid
(DNA) technology offers novel approaches towards the design and production of
drugs, vaccines and diagnostic tools.  To date, even its limited application
in these areas has been enormously successful.

40.  WHO is the lead United Nations agency in this programme area, focusing
on efforts to combat major communicable diseases and to promote preventive
health care, vaccine and diagnostic reagents development and production, and
new pharmacological development using biotechnological approaches.  The rapid
progress in molecular biology and genetic engineering provides the basis for
simplifying immunization, and for improving immunization strategy, which are
the research goals of the WHO Programme for Vaccines and Immunization.  WHO
promotes the improvement of existing vaccines, and the development of new
ones, against infectious diseases with the highest mortality or morbidity,
including acute respiratory infections, typhoid fever, diarrhoeal diseases,
acquired immunodeficiency syndrome (AIDS), tuberculosis, malaria, meningitis
and dengue.  A WHO conference on biotechnology and world health was held in
November 1994 in Geneva to assess the risks and benefits of DNA technology as
a means of producing medical products.  The overwhelming consensus was that
the great benefits of DNA technology far outweigh the potential problems
associated with its use.  The conference recommended a framework with which to
facilitate the safe and effective implementation of DNA technology for the
health-related benefit of people throughout the world.  Many products produced
by biotechnology are now among the best characterized and purest biological
medicines in clinical use today.  The meeting recommended further action in
the development, testing and use of new vaccines and other medicinal products
produced by DNA technology.  
41.  As part of the Children's Vaccine Initiative (CVI), UNDP, along with the
United Nations Children's Fund (UNICEF), WHO, the World Bank and the
Rockefeller Foundation, is establishing an autonomous institute in the
Republic of Korea committed to developing, testing and delivering affordable
new and improved vaccines for the world's children.  It is a partnership of
public and private sector institutions, agencies and companies.  It will also
assist vaccine producers in developing countries to improve vaccine production
and quality control systems.  The institute will attempt to enhance vaccine
research on diseases of particular importance to low-income countries.  This
new initiative addresses a very serious gap in protecting the health of
children, especially those living in less developed regions.

42.  ICGEB's research activities relate either to specific diseases, in terms
of diagnosis, treatment and/or vaccine production, or to the researching of
new technologies aimed at the design of innovative drugs, diagnostic kits and
vaccines.  These are targeted at being less expensive than traditional
methods, and at preventing the manipulation of dangerous material.  Human
papilloma virus (a precursor of cancer of the uterine cervix), HIV (implicated
in AIDS), hepatitis B, rotavirus and malaria are among the most important
diseases currently being investigated within ICGEB.  

3.  Programme area C:  Enhancing protection of the environment

43.  The need to prevent, halt and eventually reverse the effects of
environmental degradation through the safe uses of biotechnology is urgent. 
International organizations are promoting production processes that make
optimal use of biotechnologies for the rehabilitation of land and water, waste
treatment, soil conservation, reforestation and afforestation.

44.  Advances in biotechnology offer powerful tools for the conservation,
evaluation and use of genetic resources.  New biotechnologies and advances in
molecular genetics are essential to the understanding of the genetic structure
of species.  As the need for genetic stocks increases, important collections
will have to receive adequate technology and good financial support. 
Long-term national and international assistance is essential to conserve,
manage and use these resources.

45.  Innovative agreements, in particular the one between Costa Rica's
National Biodiversity Institute (INBio), a non-profit organization, and the
United States-based pharmaceutical firm Merck & Co., Ltd. have shown that
biotechnology offers new opportunities for global partnerships in relation to
biodiversity utilization, in particular between countries rich in biological
resources and the countries that have developed the technological expertise to
utilize biological resources sustainably.  Although it is too early to
evaluate this innovative approach to international cooperation, it deserves to
be followed with interest by the international community. 

46.  To promote the application of biotechnologies for the conservation and
sustainable use of biodiversity and to prevent, halt and reverse environmental
degradation, UNEP provides support to a number of regional Microbial Resources
Centres (MIRCENs) for the (a) collection and maintenance of microbial genetic
resources in view of the tremendous potential of microbial germplasm for
economic development and environmental management and protection; and
(b) training in, research on and pilot application of environmentally sound
biotechnologies.  Examples include increasing food production and soil
fertility through biological nitrogen fixation (BNF), biodegradation of
persistent chemicals used in agriculture and industry, bioremediation,
biocontrol of insect pests and disease vectors, bioleaching, and bioconversion
of agricultural residues and surpluses into useful products.

47.  The application of modern biotechnology for the bioremediation of
contaminated land and water has created increasing global interest and
increased demand from developing countries for technical advice and assistance
from UNIDO.  Within the UNIDO Programme on Clean Industry, UNIDO has ongoing
activities on waste minimization and industrial effluent treatment.  A series
of regional workshops are being planned and organized aimed at disseminating
information on strategies for the development of appropriate technologies and
mixtures of technologies, including new biotechnology, for the treatment of
contaminated soil and water and the treatment of industrial effluents.

4.   Programme area D:  Enhancing safety and developing international
     mechanisms for cooperation

48.  This programme area provides a framework for the environmentally sound
application of biotechnology as envisaged within chapter 16 as a whole.  As
stated in paragraph 16.29:  "There is a need for further development of
internationally agreed principles on risk assessment and management of all
aspects of biotechnology, which should build upon those developed at the
national level.  Only when adequate and transparent safety and border-control
procedures are in place will the community at large be able to derive maximum
benefit from, and be in a much better position to accept the potential
benefits and risks of, biotechnology."  Of integral importance to the issue of
ensuring biotechnology safety are the efforts of international organizations
for enhancing biosafety and developing international mechanisms for
cooperation.  In this context, the UNIDO/UNEP/WHO/FAO Informal Working Group
on Biosafety needs to be extended to include other appropriate United Nations
organizations such as the United Nations Educational, Scientific and Cultural
Organization (UNESCO) and, in particular, the International Labour
Organization (ILO), which is actively engaged in addressing biotechnology
safety and risk assessment and management issues in the workplace.  The recent
United Kingdom/Netherlands initiative on the preparation of international
technical guidelines is also of relevance.

49.  The policy issue of biosafety requires rapid and effective resolution. 
Developing countries and non-governmental organizations have expressed concern
that clandestine, indiscriminate field testing of genetically modified
organisms might be conducted in some developing countries.  At the present
time, the absence of established biosafety procedures in developing countries
constitutes a major constraint to field testing - and indeed to product
development - by those public sector initiatives designed to facilitate the
introduction of biotechnology in developing-country agriculture.

50.  At its first meeting, the Conference of the Parties to the Convention on
Biological Diversity decided to establish an open-ended ad hoc group of
experts on safety in biotechnology nominated by Governments and requested the
Secretariat to establish a panel of 15 government-nominated experts on safety
in biotechnology, with due regard for equitable geographical representation,
and in consultation with the bureau of the Conference of the Parties, assisted
by UNIDO, UNEP, FAO and WHO, to prepare a background document to be submitted
to the open-ended ad hoc group of experts.  It was determined that the
document should consider the need for and the modalities of a protocol for the
safe transfer and handling and use of living modified organisms.  The expert
panel meeting will be held in Cairo, Egypt, from 1 to 5 May 1995, at the
invitation of the Government of Egypt, and the meeting of the open-ended ad
hoc group of experts will be held in Madrid, Spain, from 24 to 28 July 1995,
at the invitation of the Government of Spain.  

5.   Programme area E:  Establishing enabling mechanisms for the development
     and the environmentally sound application of biotechnology

51.  Recognizing that biotechnology is multidisciplinary in nature and that
capacity-building for its effective environmentally sound management requires
new management strategies and approaches, several United Nations organizations
with complementary mandates and programmes have increasingly developed new
collaborative initiatives.  Programmes dealing with biosafety have expanded
beyond the scientific sector to include the concerns of workers exposed to
biological agents in the workplace (ILO), farmers (FAO) and the general
public, while programmes on marine agricultural and industrial biotechnology
call for closer cooperation among FAO, ILO, the International Maritime
Organization (IMO), UNEP, UNIDO, WHO and the World Meteorological Organization
(WMO).  Such efforts extend beyond the United Nations system to involve the
private business sector, financial institutions and non-governmental
organizations.  The regional commissions have taken steps to strengthen
in-house capacities with a view to increasing their role in coordinating the
several global biotechnology initiatives at the regional level.  UNDP has been
instrumental in fostering United Nations system-wide coordination at the
national level. 

52.  Various United Nations and other international organizations are engaged
in efforts, at the global, regional and national levels, to help countries,
particularly developing countries, to take advantage of opportunities offered
by rapid advances in biotechnology.  Collaborative programmes have been
initiated in response to Agenda 21 that enhance training capacity, technical
knowledge, research and development facilities, and industrial capacity, and
that promote awareness and understanding of the issues surrounding
intellectual property rights protection with respect to biotechnology.  A
broad range of demands, ranging from information to technology on biosafety
and biotechnology and from advisory services to financial and management
support, experienced through these efforts indicated the need for a more
effective integrated approach and closer cooperation in many aspects.

53.  Lessons drawn from development cooperation experiences suggest that the
"top-down" approach has shortcomings and that the success of aid programmes
and projects depends to a large extent on the participation of developing
countries at all levels and phases of design and implementation.  They also
suggest that if biotechnology is to have a significant impact on developing-
country agriculture, long-term commitments will be required.

54.  Recognizing the high costs of research in biotechnology, several
existing agricultural research institutes have strengthened or initiated new
biotechnology programmes to address the common elements of research and
development as well as the training needs of developing countries in many
areas outlined under programme area E, with support from financial
institutions, foundations and, to a lesser extent, the private business
sector.  Intergovernmental technological institutions such as ICGEB have been
instrumental in providing regular training programmes aimed at capacity-
building of developing countries.  Through its network of Affiliated Centres
in the various regions, collaborative research projects with national
institutions in the developing countries have been encouraged with a view to
more effectively addressing regional and national concerns.  At the same time,
through its pre-doctoral and post-doctoral fellowship programmes, aimed at
training in the best possible environmental and scientific facilities, the
Centre ensures the transfer of technology to its member countries.  

55.  The regional commissions have organized conferences aimed at enhancing
awareness of the opportunities offered by biotechnology.  Some conferences
have been aimed at promoting links between business enterprises and
biotechnology research and development institutions, both within the
developing country region and between the region and developed countries.  The
conferences have demonstrated the need for a focused approach to enable
specific areas in biotechnology to be targeted by local research and
development institutions.  They have confirmed the need to establish stronger
links between these institutions and sources of investment and private
enterprise.  Areas meriting further concentrated efforts include the
development of marine agricultural and industrial biotechnologies and
agricultural and agro-industrial applications of genetic engineering and plant
cell and tissue culture.

56.  UNDP's recent emphasis on sustainable human development (an approach
shared by other United Nations bodies) encourages the participatory
involvement of local organizations and people in the planning and
implementation of scientific endeavour, and seeks to avoid a heavy dependence
on the transfer of technology.  Thus, it is hoped that in the future it will
be possible for biotechnology to be regarded as one (major) constituent of a
broader multisector planning approach.


                         III.  GENERAL LESSONS LEARNED

57.  Enormous scope exists in many countries for productivity gains, for
improvement in the quality of food and agricultural products, and for
conservation of the environment, using existing technologies that are
available but not being applied.  A key issue for developing countries,
therefore, should be selectivity in determining whether biotechnology might
provide the most effective solution, from the cost as well as the social point
of view.  For biotechnology to be fully integrated into national priorities
and policies, not only does it need to be understood but its potential
benefits need to be appreciated by policy makers.

58.  The international biotechnology programmes of the United Nations
organizations, the OECD Development Centre, and donor organizations and their
bilateral and multilateral aid programmes demonstrate the extent to which
countries can take advantage of new technology.  Whether this is through
"endogenous" development, international technology transfer or, more often, a
combination of the two, will depend on national conditions and policies. 
External "cooperation" can facilitate technology development and diffusion,
but it can only complement - not substitute for - national efforts, capacities
and policies.

59.  Past limited experiences by organizations concerned with the successful
transfer to and development of biotechnology in developing countries indicated
that the successes were based on strategic alliances with institutions in
developed countries either at the development stage or at both the research
and development stages.  Such strategic alliances might involve public
institutions or the private industrial sector or both.  One common key factor
in most cases was the involvement and participation of an intermediary
organization, often with financial and/or technical support.  The key roles of
intermediaries were to identify and assess appropriate technologies and to
facilitate negotiation between the two parties in terms of contracts for
cooperation, which included licensing agreements and the sharing of benefits. 
It may be concluded that this technology management (or intermediary) service
was a crucial factor.  As such, the role of the intermediary organization, as
a candidate for future encouragement and promotion, should be further studied
and evaluated.

60.  For biotechnology to be successfully developed, public as well as
private support, and support from non-governmental organizations, are needed. 
Financial support to the scientific community alone is not enough.  Various
new incentive measures, including positive financial, legal and new management
mechanisms and approaches for promoting private-public sector collaboration,
are essential.  In most developing countries, public institutions are the main
centres in which research is being undertaken on the emerging biotechnologies.

The industrial sector and individual entrepreneurs in many of these countries
have still to gain confidence in the potential of investing in commercializing
results emanating from the research laboratories.  In addition, the general
public is still inadequately informed about the benefits and risks associated
with the development and applications of biotechnology, even though science
and technology are seen by many as engines of economic progress.  For these
and other reasons, constraints such as low levels of public acceptance in
certain countries and inadequate support by Governments and the private sector
continue to exist.  Lessons learned from development cooperation experiences
over the years suggest that the "top-down" approach has severe shortcomings
and that the success of aid programmes and projects depends heavily on the
full participation of developing countries at all levels of society and during
every phase of design and implementation.  Furthermore, if biotechnology is to
have a truly significant impact, long-term commitments will be required.


        IV.  CONCLUSIONS AND PRIORITY ISSUES FOR FURTHER CONSIDERATION

                                A.  Conclusions

61.  Since the United Nations Conference on Environment and Development,
scientists and policy makers have begun to give high priority to biotechnology
development.  The more biotechnologically advanced developed countries, having
increasingly privatized biotechnology research and development, continue to
forge ahead rapidly in several sectors, expanding in particular from the
pharmaceutical and health sector (programme area B of chapter 16) to the
agricultural sector (programme area A), with a development trend towards the
environmental sector (programme area C).  Environmental biotechnology in the
future seems increasingly likely to be focused on the conservation, protection
and sustainable utilization of the world's scarce natural resources.  As a
cross-sectoral technology, it ought to be possible to apply biotechnology
where appropriate and assist in tackling many of the challenges identified in
other chapters and programme areas of Agenda 21, though biotechnology should
not be regarded as a magic wand for solving all problems.

62.  Although the "new" biotechnology began to emerge as a science more than
two decades ago, Agenda 21 has been instrumental in focusing global attention
on the contribution that biotechnology can make in efforts to achieve
sustainable development while safeguarding the environment.  Biotechnology
applications have the potential for making major contributions to the health
and welfare of humanity, although biotechnology is still perceived by many to
have undesirable and partly unforeseeable ecological, socio-economic, legal
and ethical implications.

63.  The issue of biosafety is dealt with in detail in programme areas D and
E in chapter 16, with a strong emphasis on capacity-building and the need for
international agreement.  A coherent system of controls is not yet in place,
despite the intensity of the debate on the issue of safety in biotechnology
during and subsequent to the United Nations Conference on Environment and
Development process.  It is widely recognized, however, that it is critical -
especially in developing countries - to establish standards for the
development, handling and commercialization of biotechnology products to
protect human and animal health and to safeguard the environment.

64.  The first steps towards a possible international system of controls were
taken at the first meeting of the Conference of the Parties to the Convention
on Biological Diversity in Nassau, the Bahamas, in November 1994.  The issue
of safety in biotechnology extends well beyond the conservation and
sustainable use of biological diversity, however.  The Commission on
Sustainable Development is uniquely placed to set this issue within the
context of sustainable development in its widest possible sense.

65.  With the increasingly rapid rate of biotechnology development and the
increasing privatization of biotechnology, particularly in many industrialized
countries, and in so far as biotechnology is a science- and
knowledge-intensive field, technological and information gaps between these
countries and many developing countries are increasing.  There is concern
about the ability of these developing countries to acquire and manage new
biotechnology without experiencing potential negative impacts.  Furthermore,
those countries are constrained by lack of resources from restructuring their
science and technology infrastructure, from acquiring new technology
management skills, and from adjusting to new standards in biosafety and to
increasing pressures to adopt intellectual property rights protection in
relation to biotechnology.  The enormous changes in technological capabilities
in some developing countries in recent years should also be borne in mind,
however, as well as the wide differences among developing countries in their
ability to acquire and manage biotechnology.

66.  Several international and bilateral programmes, responding to the needs
and concerns of developing countries, have strengthened their activities. 
Many have introduced new initiatives in biotechnology, ranging from capacity-
building for the improvement of traditional and intermediate biotechnologies,
such as food fermentation and tissue culture, to the introduction of new
biotechnologies, such as diagnostics and biopesticides, and from information
dissemination to advisory services on biosafety and, to a lesser extent, on
intellectual property rights protection in relation to biotechnology.  Such
programmes are also constrained by the inadequacy of available financial
resources, specially when compared with private financing in industrialized
countries.  They have nevertheless already successfully demonstrated in many
developing countries the potential of biotechnology applications for
improvements in agricultural productivity and in health care, as well as in
the diversification of industry, and the conservation of the environment.  

67.  The extent to which countries can take advantage of new technologies
depends heavily on a range of national priorities and prevailing economic and
social conditions, and especially upon the degree of participatory planning
among all stakeholders.  In a number of developing countries, biotechnology
association membership is mixed and is drawn from both the academic and the
industrial sector, but these associations are less active in policy-related
matters.  In many other countries, biotechnology association membership is
confined to scientists.  Where they exist, biotechnology associations provide
an effective forum for information exchange as well as a mechanism for
private-public sector cooperation.  

68.  Although initiatives and efforts in biotechnology have been evenly
distributed among the various regions, countries in Asia and Latin America
have advanced to more sophisticated levels than those in the other developing
regions.  Countries in Eastern and Central Europe, with their strong
foundation in science, also show strong potential to benefit from
biotechnology development.  Effective policy formulation and prioritization of
resource allocation have helped countries such as Cuba to achieve considerable
success in biotechnology development.  South-South networking arrangements,
such as the Plant Biotechnology Network (REDBIO) in the Latin America and the
Caribbean region, and intergovernmental scientific and technological
initiatives such as the International Centre for Genetic Engineering and
Biotechnology (ICGEB) with bases in Trieste, Italy, and New Delhi, India, and
Affiliated Centres in its several member States, have been effective in
diffusing biotechnology among and to developing countries in different
regions.

69.  In matters related to financing, the available information indicates a
level of support far below what is required if developing countries are to
participate in and benefit from biotechnology development to ensure
sustainable development for all mankind.  Meeting the many and varied economic
and institutional requirements needed to enable chapter 16 to be fully and
effectively implemented with the limited funding currently available from the
international community points to the need to focus upon financing high-
quality biotechnology programmes and initiatives and to giving priority to
ensuring the continuity of financial support.  Lessons from the still limited
investments by regional banks in biotechnology projects indicate a major
potential for expanding the role of financial institutions at various levels
in promoting biotechnology programmes.  

70.  Intellectual property rights issues with respect to biotechnology have
increasingly become the subject of debate in both developed and developing
countries, as well as in international forums, notably the TRIPS and, more
recently, the Convention on Biological Diversity.  Special problems can arise
as a result of the gradual extension of patents to new biotechnologies,
especially genetic engineering biotechnology, in the absence of clear-cut
international minimum standards.

71.  The Green Industry Biotechnology Forum (GIBiP), an industrial
association of plant biotechnology-related food and agricultural businesses,
has sponsored one much-welcomed initiative in this area by establishing an
industry-oriented database on field trials of new biotechnology products. 
This database contains information complementary to the national country
information on biosafety contained in the BINAS and OECD Biotrack databases.


                              B.  Priority issues

72.  In light of the review and assessment above, a number of priority issues
can be identified, as follows:

     1.   The key role of the private sector - business, industry and the
          banks - in promoting and applying biotechnology for sustainable
          development to meet the objectives of chapter 16

73.  Some biotechnology business reports on commercial biotechnology predict
that the coming decade will see an increasing number of products entering the
market-place with a tendency for more flexible regulation of biotechnology
products.  As commercial biotechnology development increases in scope and
volume and with the trend towards a globalized economy, the impact of
biotechnology itself is likely to become increasingly global in nature.  It
will be critical, therefore, for efforts to be made to ensure that any
expansion in commercial activities of this kind makes a positive contribution
to the attainment of global sustainable development.  The private sector needs
to be actively encouraged to contribute to efforts to work towards sustainable
development through the development and use of environmentally sound
biotechnologies that balance social, environmental and economic objectives and
the dissemination of reliable and accurate information to the public.  The
banking sector - especially the regional banks - need to be encouraged to
participate more actively in the development, and especially the
commercialization, of biotechnology, particularly in developing countries.

     2.   The need to integrate biotechnology concerns into national
          sustainable development policies for making and building national
          capacities

74.  An increasing number of countries have identified biotechnology as a
priority area for economic development, especially in science and technology
education and research.  However, although biotechnology can play an important
role in the development of several sectors including agriculture and health,
environment, energy, industry, education and trade, biotechnology concerns are
not usually sufficiently integrated into wider policy-making at the national
level.  There is a need for national development policies and planning to
address issues such as the development of management skills for selecting,
assessing and prioritizing biotechnologies; the selection of necessary and
appropriate standards and regulations for quality and environmental control;
legislation and regulation with respect to biosafety issues and intellectual
property rights issues with respect to biotechnology; and special economic
measures such as tax and legal ones so that businesses may foster the
successful commercialization of environmentally sound biotechnology
applications.  Efforts need to be made to mobilize to the fullest possible
extent and build upon existing mechanisms, such as BINAS within the United
Nations system, as well as other informal mechanisms such as the Biotechnology
Advisory Commission of the Stockholm Environment Institute, the International
Service for National Agricultural Research/International Biotechnology Service
(ISNAR/IBS), and the Agricultural Biotechnology for Sustainable Productivity
(ABSP) project, and to make the most effective use of regional meetings and
training supported by those organizations.  Moreover, there is a real need for
a coherent and comprehensive response from the various United Nations and
other international development organizations.  More concerted efforts by the
various United Nations organizations concerned and other international
programmes, including in particular private sector initiatives such as the
International Service for the Acquisition of Agri-Biotech Applications
(ISAAA), will be needed to meet the increasing needs of developing countries
in this area.

     3.   The need to achieve and demonstrate safe and viable results for
          sustainable development in the application of biotechnology

75.  There continues to be considerable speculation and debate about the
potential risks and benefits associated with biotechnology.  The economic
returns resulting from those biotechnology applications that have been
supported by venture capital have encouraged a steady increase in investment
in biotechnology, yet the beneficial results of applications in developing
countries and the benefits derived from such applications are not perceived to
have extended much beyond the business community.  There is a clear case for
identifying and disseminating information about the examples of "best
practice" environmentally sound applications that have resulted in a
demonstrable meeting of the sustainable development objectives of programme
areas A, B and C of chapter 16, especially as they relate to farming or other
communities and to small- and medium-sized rural enterprises, in particular in
developing countries.

     4.   Safety in biotechnology

76.  As the question of safety in biotechnology goes beyond the conservation
and sustainable utilization of biological diversity, which comprises the main
focus of the work on a possible protocol under the Convention on Biological
Diversity, there is a need to assess how far the objectives and activities of
programme areas D, especially paragraphs 16.32 (a), (b) and (c), and E, are
being effectively addressed and implemented within the context of this and any
other appropriate ongoing processes, with a view to identifying gaps in
existing efforts.  Such a review would benefit from regional meetings and
consultations organized by the various United Nations organizations and other
international programmes within the framework of Agenda 21.  The immediate
need for developing countries to develop national regulatory mechanisms in
biosafety issues along with the related capacity for their implementation is
an issue to be urgently addressed.  Ongoing United Nations and other
international initiatives to follow up chapter 16, especially in terms of
regional consultations and the preparation of international technical
guidelines, should be supported.

     5.   Matters related to intellectual property rights

77.  Action is urgently needed to facilitate the effective participation of
developing countries in the process directed towards adopting realistic and
up-to-date standards for intellectual property rights on biotechnology, taking
into consideration new advances in and the understanding of biotechnology, as
well as its crucial role in sustainable development, its potential impact on
human society, and opportunities for mutually beneficial collaboration and
cooperation.  


     6.   The need to promote greater awareness of biotechnology issues

78.  Public concern continues to be expressed over the impact of
biotechnology, especially as it relates to social, moral and cultural values. 
At the national level, bioscience and biotechnology need to be appropriately
introduced into school curricula.  The general public needs to be adequately
informed of the potential impacts of the technology on people and society and
its concerns addressed in an open and transparent manner.  Special efforts
need to be made to involve the media with a view to the presentation of an
impartial understanding of emerging biotechnology and its impacts.  The
private sector in both developing and developed countries has a role to play
in providing up-to-date, accurate and reliable information in connection with
the commercialization of new products and processes.  


                           V.  PROPOSALS FOR ACTION

79.  In the light of the priority issues identified, the Commission on
Sustainable Development may wish to take action on the following matters:

     (a)  Enhancing the contribution of the private sector to sustainable
development, by urging Governments to involve business, industrial and banking
interests more actively in safely applying and promoting biotechnology to meet
the sustainable development objectives of chapter 16, with particular
reference to:

     (i)  Participation in and contribution to national, regional and
          international consultations on biotechnology development trends and
          impact assessment;

    (ii)  Support for independent research and educational institutions in
          conducting case-studies on "best practice" environmentally sound and
          viable applications for biotechnology, especially in developing
          countries;

   (iii)  Support for the establishment of biotechnology associations in
          developing countries to facilitate the commercialization and
          application of biotechnology products and processes, including human
          resource development in biotechnology management; 

    (iv)  Other appropriate, innovative and environmentally sound approaches,
          especially with regard to financing international, regional and
          national biotechnology programmes;

     (b)  Integrating biotechnology concerns into national-level development-
policy making and building of national capacities, by requesting Governments,
supported by United Nations and other appropriate intergovernmental bodies,
to:

     (i)  Ensure the participation and contribution of all major groups in the
          integration process;

    (ii)  Enhance public awareness through promoting and disseminating an
          accurate understanding of biotechnology that includes the issues
          associated with progressive trends in its development;

   (iii)  Support cross-fertilization of ideas between and among major groups
          to enable decision makers to identify problems to be solved and to
          recognize the appropriateness, feasibility and sustainability of
          perceived biotechnological solutions; 

    (iv)  Strengthen environmentally and economically sustainable capabilities
          in the sound management of biotechnology, including matters relating
          to intellectual property rights;

     (v)  Establish national databases on information relating to biosafety in
          biotechnology; 

    (vi)  Assess the need for advice and assistance in promoting appropriate
          biotechnology and biosafety regulations where these do not already
          exist or need to be strengthened, with a view to designing effective
          programmes, building wherever possible on existing capabilities;

     (c)  Promoting "best environmentally sound and viable practices", by
calling on Governments, with maximum support from United Nations and other
organizations as well as the private sector, to identify and exchange
information, especially at the regional level, about examples of "best
practice" viable and environmentally sound applications that have resulted
demonstrably in meeting the sustainable development objectives of programme
areas A, B and C of chapter 16;

     (d)  Encouraging the environmentally sound application of biotechnology
for sustainable development, by:

     (i)  Taking note of the decision of the first meeting of the Conference
          of the Parties to the Convention on Biological Diversity to
          establish a process for determining the possible need for and
          modalities of a protocol on biosafety;

    (ii)  Assessing how far the objectives and activities of programme areas D
          and E are being effectively implemented at the national, regional
          and global levels; and making recommendations on possible further
          steps needed to address the wider issue of safety in biotechnology; 

   (iii)  Urging Governments to encourage the scientific communities in their
          countries, as public stewards, to take the lead in exercising an
          ethical responsibility through safe laboratory practices and good
          communications with the public at large;
     
     (e)  Considering the steps required for the possible development of
strategies for meeting the sustainable development objectives of Agenda 21,
including the need to:

     (i)  Initiate a procedure for periodic reviews of biotechnology
          development trends to ensure the effective integration of the new
          biotechnology into global sustainable development efforts;

    (ii)  Cooperate closely with the Convention on Biological Diversity with a
          view to following developments on the process for determining the
          possible need for and modalities of a protocol on biosafety and to
          ensure coordination, especially in identifying gaps and initiating
          follow-up action;

   (iii)  Seek advice from an ad hoc group of experts on such steps.


                                     Notes

     1/   United Nations Conference on Environment and Development, Rio de
Janeiro, 3-14 June 1992, vol. I, Resolutions Adopted by the Conference (United
Nations publication, Sales No. E.93.I.8 and corrigendum), resolution 1,
annex II.

     2/   See United Nations Environment Programme, Convention on Biological
Diversity (Environmental Law and Institution Programme Activity Centre),
June 1992.

     3/   United Nations Conference on Environment and Development, Rio de
Janeiro, 3-14 June 1992, vol. I, Resolutions Adopted by the Conference (United
Nations publication, Sales No. E.93.I.8 and corrigendum), resolution 1,
annex I.



                                    Annex I

               UNITED NATIONS SYSTEM AND INTERNATIONAL ORGANIZATION
               ACTIVITIES IN SUPPORT OF CHAPTER 16 OF AGENDA 21:   
               ENVIRONMENTALLY SOUND MANAGEMENT OF BIOTECHNOLOGY


1.   Since the United Nations Conference on Environment and Development
(UNCED) much work has been done by the United Nations system and international
organizations in support of chapter 16:  Environmentally sound management of
biotechnology of Agenda 21.

     1.   Programme area A:  Increasing the availability of food, feed and
          renewable raw materials

     Objectives:

          (a)  Increase to the optimum possible extent the yield of major
     crops, livestock, and aquaculture species, by using the combined
     resources of modern biotechnology;

          (b)  Improve the nutritional value of source crops, animals and
     micro-organisms and reduce food losses using environmentally safe
     applications of biotechnology;

          (c)  Increase the use of integrated pest, disease and crop
     management techniques to eliminate overdependence on agrochemicals,
     thereby encouraging environmentally sustainable agricultural practices;

          (d)  Evaluate the agricultural potential of marginal lands in
     comparison with other potential uses and develop, where appropriate,
     systems allowing for sustainable productivity increases, including
     situations of emerging environmental stresses;

          (e)  Expand the applications of biotechnology in forestry;

          (f)  Increase the efficiency of nitrogen fixation and mineral
     absorption by the symbiosis of higher plants with micro-organisms;

          (g)  Improve capabilities in basic and applied sciences and in the
     management of complex interdisciplinary research projects.

2.   FAO is a leading United Nations organization in promoting the
application of agriculture biotechnology among developing countries and is
presently assisting more than 30 developing countries in the uses of advanced
but relatively conventional biotechnology for increased yield and quality of
food and feed crops, cash crops and livestock through the formulation and
implementation of specific projects in these areas.  For example, a
UNDP/FAO/UNIDO Regional Subprogramme on Asian Biotechnology and Biodiversity,
of the Farmer-Centred Agricultural Resources Management (FARM) programme, in
which eight countries, namely China, India, Indonesia, Nepal, the Philippines,
Sri Lanka, Thailand and Viet Nam, are participating, is assessing and
pilot-testing appropriate biotechniques and products to enhance crop and
livestock productivity through the development and promotion of in vitro
culture techniques and embryo transfer.  A similar FAO-sponsored regional
network on plant biotechnology is operational in the Latin America and the
Caribbean region.  Rice biotechnology, supported by the Rockefeller
Foundation, has an extensive network involving several countries in which
ICGEB participates.  In the European region, through the European System of
Cooperative Research Networks in Agriculture (ESCORENA), FAO promotes research
networks on rice, sunflower and cotton and specific working groups in the
application of biotechnology are operational.  Biotechnology for improved
production of buffalo, flax and nuts is being pursued.

3.   The Plant Breeding and Genetics Section of the Joint FAO/IAEA Division,
International Atomic Energy Agency, supports the use of biotechnology for
plant improvement by promoting tissue and cell culture and molecular
techniques through Technical Cooperation Projects (TC) and Coordinated
Research Programmes (CRP) on mutation induction.  Micropropagation for rapid
multiplication of selected mutants as disease-free plants is an important
component of several TC/CRP programmes.  Anther and microspore culture
techniques, to obtain homozygous diploid mutants following irradiation, are
frequently used in several mutation-breeding projects supported by the Agency.

The development of protocols of in vitro selection of mutants for disease
resistance and stress tolerance is a key element in the promotion of
sustainable agriculture, and is also supported by the Joint Division.  Plant
and tissue culture technologies are being used to propagate in vitro
irradiated plants of banana, plantain, cassava, and so forth.  To encourage
environmentally sustainable agricultural practices while moving away from
overdependence on agrochemicals, UNEP, in collaboration with FAO, UNESCO and
other relevant organizations, supported the regional Microbial Resources
Centres (MIRCENs) in Cairo, Nairobi, Dakar, and Porto Alegre in demonstrating
on a pilot scale the use of biological nitrogen fixation (BNF) for enhancing
soil fertility and increasing legume production at the small-farm level. 
Activities include collection, evaluation, and preservation of Rhizobium
strains; the establishment of pilot plants for inoculant production; and
training of local BNF professionals, technicians and extension workers to
popularize the technology.  In the field of animal production, FAO's
biotechnology work encompasses three main areas:  (a) better disease
diagnosis; (b) better and safer vaccines for disease prevention; and (c)
genetic manipulation of the germline of economically important livestock to
improve specific disease resistance.  Global and regional expert consultations
on new and emerging areas of animal biotechnology for the benefit of
developing countries are organized on a regular basis.

4.   Several networks on the subject are being developed by FAO that include
Reference Laboratories (20 institutions) and Collaborating Centres
(internationally recognized centres of expertise covering infectious and
parasitic diseases and using modern biotechnology methods), the FAO TC Network
on Animal Production and Health Biotechnology for Latin America (8 countries)
and South-East Asia (7 countries), the Computer Assisted Network on Nucleic
Acid and Protein Sequencing (CANAPS) in Latin America/Caribbean (14
countries), and the FAO Network Programme on Veterinary Biotechnology in
Central and Eastern Europe (4 countries with economies in transition).  The
Joint FAO/IAEA Division in Vienna developed with other institutions the ELISA
sero-monitoring kit for rinderpest antibodies.  The Pan African Network on
ELISA Sero-monitoring for the Pan African Rinderpest Campaign (PARC) includes
over 20 countries.  The ELISA Programme for Latin America covers foot-and-
mouth disease, brucellosis and babesiosis and involves 12 countries.

5.   FAO has also been promoting such development of recombinant vaccines
against rinderpest as ensures their safety and potency testing.  These may
supplement in the future the Plowright's Kabeta "O" classical vaccine which is
being widely used for ongoing rinderpest eradication campaigns in Africa
(PARC), Middle East/West Asia (WAREC) and South Asia (SAREC).  Similarly,
successful attempts have been made to increase the Plowright's vaccine shelf-
life by a modified freeze-drying scheme and the application of stabilizers.  A
strict, standardized quality control of rinderpest and Contagious Bovine
Pleuropneumonia (CBPP) vaccines initiated by the Pan African Veterinary
Vaccine Centre (PANVAC) resulted in a significant improvement in the quality
of the vaccines applied in campaigns against rinderpest.  Specific FAO
projects in Asia and the Middle East promote the application of fermentation
methods for the large-scale production of bacterial aerobic and anaerobic
vaccines.  At the grass-roots level, preparations have started in developing a
network on orally administered Newcastle disease NDV-4 vaccines that may be
extensively applied by women's rural communities to supplement already applied
immunization schemes.  The FAO/IAEA Joint Division, with multi-country
support, has been instrumental in eradicating deadly pests and diseases
through the development and use of the Sterile Insect Technique, in particular
in the management in Africa of the tsetse fly, a pest that causes
trypanosomiasis.

6.   To promote sustainable agriculture and its diversification while
increasing the yield of major crops and livestock and the productivity of
marginal lands, UNEP in cooperation with FAO, various United Nations bodies
and with the International Plant Genetic Resources Institute (IPGRI) and the
International Centre for Agricultural Research in Dry Areas (ICARDA),
initiated programmes aiming at the collection, evaluation and conservation of
plant, animal and microbial genetic resources, using modern and conventional
technologies, and the training of developing-country scientists in relevant
technologies.  In this respect, ICGEB has made available to member developing
countries research and development and training facilities as well as the
relevant genetic information through its ICGEBNet service.  With respect to
sustainable use of raw materials, such as medicinal and aromatic plants, UNIDO
and FAO work closely with developing countries to introduce systematic
cultivation or harvesting in combination with small-scale processing
technologies to increase value-added benefit to local communities.  UNESCO has
supported, through its Biotechnology Action and in cooperation with the
UNESCO/UNEP MIRCEN Network, a variety of activities ranging from training
courses, fellowships and research projects to award professorships,
establishment of chairs and provision of authenticated laboratory protocols in
biotechnologies.  In addition, ICGEB has major research programmes to increase
the yield of major crops through the study both of plant stress resistance,
tolerance to herbicides and resistance to some specific pests and toxins, and
of lignin biodegradation aimed at the recycling of vegetal wastes as feed
stock.  Research programmes extend beyond the Centre to many of its 20
Affiliated Centres in developing countries.

7.   WMO provides services to member countries to help them make optimal use
of weather information to increase food and agriculture production, to reduce
risks, and to reduce crop losses due to various factors including weather
hazards, pests and diseases.

8.   The joint ECE/FAO Working Party on Relations between Agriculture and the
Environment periodically reviews governmental economic, regulatory and
technological measures for the promotion of sustainable agriculture and
production of healthy food.  Exchange of information and experience on the
effective implementation of these measures is concentrated in particular on
organic and integrated agriculture and the uses of biotechnology. 
Recommendations, guidelines and codes for the promotion of good agricultural
practices favourable to integrated pest and crop management are being
developed.

     2.   Programme area B:  Improving human health

     Objectives:

          (a)  Develop programmes to help combat major communicable diseases
     and to promote preventive health care including vaccine and diagnostic
     reagents development and production, and new pharmaceutical development
     using biotechnological approaches;

          (b)  Promote good general health;

          (c)  Develop and improve programmes to assist in specific treatment
     of and protection from major non-communicable diseases;

          (d)  Develop and strengthen appropriate safety procedures based on
     programme area D, taking account of ethical considerations;

          (e)  Create enhanced capabilities for carrying out basic and applied
     research and for managing interdisciplinary research.

9.   WHO is the lead United Nations organizations in this programme area,
focusing on efforts to combat major communicable diseases and to promote
preventive health care, vaccine and diagnostic reagents development and
production, and new pharmacological developments using biotechnological
approaches.  The rapid progress in molecular biology and genetic engineering
provides the basis for simplifying immunization, and for improving
immunization strategy, which are the research goals of the WHO Programme for
Vaccines and Immunization.  WHO promotes the improvement of existing vaccines,
and the development of new ones, against infectious diseases with the highest
mortality or morbidity, including acute respiratory infections, typhoid fever,
diarrhoeal diseases, AIDS, tuberculosis, malaria, meningitis and dengue.  A
WHO meeting on Biotechnology and World Health was held in November 1994 in
Geneva, with the participation of researchers, industry, legislative and
customer organizations.  The meeting recommended further action in the
development, testing and use of new vaccines and other medicinal products
produced by DNA technology.  With respect to biosafety, WHO plays an
increasingly active role in cooperation with other United Nations bodies, in
particular FAO, based on the Joint FAO/WHO consultation on assessing the
safety of foods.  WHO's 1993 review of the health aspects of marker genes in
genetically modified plants concluded that genes per se did not constitute a
safety concern.  WHO is of the opinion that safety precautions and monitoring
procedures should be appropriate to the level of assessed risk in the testing
and use of biotechnological products.

10.  A high-level jointly sponsored UNESCO/WHO Technical Meeting in January
1994 covered a wide spectrum of research activities ranging from drug
development, vaccine research, vector control, national capacity-building and
social science research to health education.  UNESCO, UNDP and the Government
of the Islamic Republic of Iran are collaborating in the use of an
antibacterial biocide from Bacillus thuringiensis against malaria.  In
addition, UNDP, UNESCO and UNIDO are jointly supporting a multi-country
research project concerning the development of diagnostic kits for
leishmaniasis, trypanosomiasis, schistosomiasis and enteric diseases.

11.  As part of the Children's Vaccine Initiative (CVI), UNDP, along with
UNICEF, WHO, the World Bank and the Rockefeller Foundation, is establishing an
autonomous institute in the Republic of Korea committed to developing, testing
and delivering affordable new and improved vaccines for the world's children. 
It is a partnership of public and private sector institutions, agencies and
companies.  It will also assist vaccine producers in developing countries to
improve vaccine production and quality control systems.  The institute will
attempt to enhance vaccine research on diseases of particular importance to
low-income countries.  This new initiative addresses a very serious gap in
protecting the health of children, especially those living in less developed
regions.

12.  ICGEB's research activities relate either to specific diseases, in terms
of diagnosis, treatment and/or vaccine production, or to the research of new
technologies aimed at the design of innovative drugs, diagnostic kits and
vaccines.  These are targeted at being less expensive than traditional
methods, and at preventing the manipulation of dangerous material.  Human
papilloma virus (a precursor of cancer of the uterine cervix), HIV (implicated
in AIDS), hepatitis B, rotavirus and malaria are among the most important
diseases currently being investigated within ICGEB.  

13.  The Industry and Technology sections of the Economic and Social
Commission for Western Asia (ESCWA) are providing assistance to the Arab Union
of Manufacturers of Pharmaceuticals and Medical Appliances (AUMPMA) in
planning a seminar and workshop to be held within 1995, both dedicated to
exploring possibilities of utilizing biotechnology in the pharmaceutical
industries of the AUMPMA Member States.  The seminar will be dedicated to the
large-scale manufacture of raw materials for pharmaceuticals while the
workshop will focus on the manufacture of diagnostic reagents and devices.

     3.   Programme area C:  Enhancing protection of the environment

     Objectives:

          (a)  Apply biotechnologies for the conservation and sustainable use
     of biodiversity;

          (b)  Prevent, halt and reverse environmental degradation through the
     appropriate use of biotechnology in conjunction with other technologies,
     while supporting safety procedures as an integral component of this
     programme.  Specific objectives include the inauguration as soon as
     possible of specific programmes with specific targets.

14.  To promote the application of biotechnologies for the conservation and
sustainable use of biodiversity and to prevent, halt and reverse environmental
degradation, UNEP provides support to a number of regional Microbial Resources
Centres (MIRCENs) for the (a) collection and maintenance of microbial genetic
resources in view of the tremendous potential of microbial germplasm for
economic development and environmental management and protection; and
(b) training in, research on and pilot application of environmentally sound
biotechnologies.  Examples include increasing food production and soil
fertility through biological nitrogen fixation (BNF), biodegradation of
persistent chemicals used in agriculture and industry, bioremediation,
biocontrol of insect pests and disease vectors, bioleaching, and bioconversion
of agricultural residues and surpluses into useful products.  The MIRCEN
concept was conceived by UNEP and realized in collaboration with UNESCO; the
Centres act as centres of excellence for training in environmental
microbiology and biotechnology, the conservation of microbial genetic
resources of regional relevance, and their pilot application in environmental
management.  Each MIRCEN is supported by selected institutions in developed
countries to increase international cooperation and exchange of expertise in
this area.

15.  UNEP conceived and supported the establishment and use of the
international Microbial Strain Data Network (MSDN) as a referral system of
information on microbial strains and cell lines and the international
Information Resource on the Release of Organisms into the Environment (IRRO). 
IRRO is a global information network concerned with information on the
introduction of genetically modified and novel organisms into the environment.

Training programmes were conducted by IPGRI/UNEP on the characterization and
conservation of plant genetic resources and gene banks management.  As a
follow-up to Agenda 21, UNEP initiated a global biodiversity assessment
regarding the main aspects of biodiversity including biotechnologies related
to its conservation and sustainable use.

16.  Global and regional databanks on animal genetic resources have been
established and the first edition of the World Watch List for Domestic Animal
Diversity was produced in 1993 by FAO/UNEP.  Training in relevant
biotechnologies is being offered with UNEP support at specialized institutes.

17.  A project being submitted for funding by the Global Environment Facility
on behalf of eight countries is "Biodiversity and Natural Resource
Conservation and Management for Sustainable Agricultural Production in the
Fertile Crescent".  The project, to be executed by the International Centre
for Agricultural Research in the Dry Areas (ICARDA) in the ESCWA region and
the International Plant Genetic Resource Institute (IPGRI), will include
agricultural biotechnologies and genetic engineering components.

18.  The FAO/UNIDO/UNDP Asian Subprogramme on Biotechnology and Biodiversity
has selected pilot sites in different agro-ecological areas in eight Asian
countries where biotechniques to characterize and utilize biodiversity may be
used.  FAO is assisting several developing countries in strengthening their in
vitro culture and other biological capabilities; this programme includes the
training of people for the conservation, characterization and utilization of
genetic resources.  Recently UNIDO joined UNDP and FAO in launching the
Bioinformatics Network on Biotechnology and Biodiversity.  It links eight
Asian countries, facilitating information dissemination to developing
countries and the sharing of information among network members.  Within each
country, non-governmental organizations and the business sector are encouraged
to participate in the Network.

19.  A new OECD project was recently initiated to identify impediments to the
diffusion and deployment of bioremediation technologies.  Also to be
identified are policy options to overcome these impediments.  This work builds
on an analysis of the scientific basis for bioremediation carried out by
OECD's Committee on Scientific and Technology Policy through its work on
"Biotechnology for a Clean Environment".

20.  Applications of modern biotechnology for bioremediation of contaminated
land and water has created increasing global interest and subsequently
increased demand by developing countries for technical advice and assistance
from UNIDO.  A series of regional workshops are being planned and organized
aimed at disseminating information on strategies for the development of
appropriate technologies and mixtures of technologies, including new
biotechnology for the treatment of contaminated soil and water and the
treatment of industrial effluents.  At a country level, UNIDO is working
closely with Viet Nam to develop a programme on microbial remediation of oil
pollutants, building on the country's relatively extensive work on petroleum
microbiology.

21.  Bioremediation of polluted groundwater, technologies for containing
pollution, biological methods of treating pollution in the unsaturated zone
above groundwaters contaminated by past industrial and military activities,
and the treatment of extracted contaminated soil are among the topics of the
regional ECE Seminar on the Prevention and Control of Groundwater Pollution to
be held in September 1995.  The Seminar will involve policy and decision
makers, lawyers, economists and managers who will also address regulations and
enforcement, liability and compensation for damage, and assessment and
planning techniques.

22.  The Convention on the Protection and Use of Transboundary Watercourses
and International Lakes (Helsinki, 1992) contains binding obligations to
parties to apply best available technologies for the treatment of industrial
waste water containing hazardous substances, to apply at least biological
treatment or equivalent processes for treating municipal waste water, and to
carry out research on the development of new technologies and environmentally
sound disposal practices.  These include the use and development of
biotechnology, and the setting up of mechanisms to exchange biotechnology
between parties for capacity-building, particularly in countries in
transition.  



     4.   Programme area D:  Enhancing safety and developing international
          mechanisms for cooperation

          Objective:  safety in biotechnology development, application,
     exchange and transfer through international agreement on principles to
     be applied on risk assessment and management.

23.  Stemming from the joint Informal UNIDO/UNEP/WHO/FAO Working Group's
Voluntary Code of Conduct for the Release of Genetically Modified Organisms
developed in 1991, and with support from the Norwegian Government, UNIDO
further formulated, according to the Code's recommendations, a Biosafety
Information Network and Advisory Service (BINAS).  BINAS contains a number of
databases that include biotechnology guidelines, regulations and standards for
the release of transgenic organisms into the environment.  UNIDO works closely
with the Organisation for Economic Cooperation and Development (OECD) in
information and data sharing, thus providing a comprehensive coverage of
developing and developed countries.  UNIDO recently put its BINAS on line,
making information and advice on biosafety issues more accessible.  The
establishment of BINAS is thus a major step towards nationalizing
environmental concerns and regulatory oversight.  Apart from its databases
containing information on countries' regulations to control environmental
applications of biotechnology, it provides a large repository of Environmental
Impact Assessments.

24.  BINAS has been and is being supported by a series of awareness seminars
and training workshops organized jointly by UNIDO and ICGEB, most of them in
close cooperation with UNEP.  A manual on biotechnology safety entitled
Genetically Modified Organisms:  A Biosafety Guidebook has been prepared by
the UNIDO secretariat and ICGEB for the Informal UNIDO/UNEP/WHO/FAO Working
Group on Biosafety.  The publication is due to be released in early 1995.  In
line with the Voluntary Code of Conduct for the Release of Organisms into the
Environment, developed jointly by UNIDO, UNEP, WHO and FAO, the organizations
are assisting in strengthening national human resources and infrastructures to
implement biosafety guidelines and procedures.  FAO is establishing a "prior
informed consent" system and is assisting in building national bio-information
systems to assist the countries in elaborating pertinent policies and
regulations related to biosafety.  ICGEB/UNIDO conduct four training courses
each year to assist national and regional regulatory authorities and to
provide ongoing technical support on risk assessment methodologies and
biotechnology safety.  UNEP plays an active role in supporting such training.

25.  Building on experience derived from a series of awareness seminars and
training workshops, especially at regional and subregional levels, and with an
increasing participation of developing countries in BINAS, considerable
progress in regional cooperation in biosafety has been made.  Specifically,
UNIDO fostered the establishment of a Task Group of Regulation Oversight of
Central and Eastern Europe in Biotechnology (ROCEEB).  The goal of its
activities is harmonization of the regulatory oversight in the region.

26.  Faced with the increasing number of workers who are exposed to
biological agents in the workplace, ILO decided to intensify its actions in
the evaluation of risk assessment data and the development of preventive
measures in the field of biotechnology.

27.  In 1993, the International Labour Conference adopted a resolution
concerning exposure to and safety in the use of biological agents at work. 
Based on this resolution, the Governing Body of ILO requested the Director
General to take fully into account, when drawing up future programme
proposals, the taking of steps to address the question of exposure to and
safety in the use of biological agents at work and consideration of the need
for new international instruments in order to minimize the risks to workers,
the public and the environment.

28.  In its 1996-1997 programme and budget proposals, the Occupational Safety
and Health Branch of ILO has plans to compile a report on biological hazards
and their prevention and on the scope for international instruments in this
field.  The report is expected to be submitted to a tripartite meeting of
experts to be held in Geneva.  Cooperation with UNIDO, WHO and UNEP will be
sought during the preparation of the meeting.  As background work, ILO has
prepared a study on the impact of modern technology, including gene
technology, on workers' health and the environment.  The study identifies
potential risks related to the introduction of these new technologies.

29.  The OECD's Environment Policy Committee (EPOC) maintains a work
programme on the Environmental Aspects of Biotechnology, which includes
linkages to an array of United Nations and other international bodies.  Its
cooperative aspects in particular involved work on the development of
"Biotrack" (OECD's computerized storage and retrieval system that contains
information on introductions into the environment of organisms derived through
modern biotechnology).  Methods for monitoring organisms in the environment
are also being analysed as a part of this work.  Broad international
cooperation, particularly through UNIDO's BINAS system, will continue.  Two
OECD EPOC projects are devoted to developing tools to enhance the
harmonization of regulatory oversight, including common methods for generating
data used to assess products; methods to encourage the mutual acceptance of
data; issues related to the assessment of data; and common approaches and
methodologies for the interpretation and evaluation of data.  The project on
"Industrial Products of Modern Biotechnology intended for Release to the
Environment" focuses primarily on organisms intended for use in
bioremediation, bioleaching and biomining as well as other similar
environmental uses.  The project on "Commercialization of Agricultural
Products derived through Modern Biotechnology" places primary attention on
agricultural crop plants derived through modern biotechnology.

30.  The FAO Commission on Plant Genetic Resources prepared and discussed a
draft Code of Conduct on Biotechnology as it affects the Conservation and
Utilization of Plant Genetic Resources at its fifth session in April 1993. 
This was the first time that a permanent United Nations intergovernmental
forum had actually discussed a draft Code of Conduct on Biotechnology,
encompassing a biosafety module.

31.  The Convention on Biological Diversity is currently discussing the
issues surrounding the need for and modalities of a possible protocol on
biosafety under the Convention.  A number of initiatives are in hand to follow
up paragraph 16.34 (a), which calls on Governments "organizing one or more
regional meetings between countries to identify further practical steps to
facilitate international cooperation in biosafety", and to consider "the need
for a feasibility of internationally agreed guidelines on biotechnology
releases, including risk assessment and risk management", and for "studying
the feasibility of guidelines which could facilitate national legislation on
liability and competition".

32.  Recent bilateral collaboration between the Governments of the United
Kingdom and the Netherlands resulted in the preparation of draft technical
guidelines on safety in biotechnology.  Following an international meeting of
experts in March 1994 in the United Kingdom to provide advice, a larger
meeting of a group of experts from 17 countries from all regions of the world
took place in May in the Netherlands.  The new guidelines are meant to provide
a practical tool in fostering international cooperation.  Related regional
meetings on international cooperation on safety in biotechnology were held in
Harare, Zimbabwe, in October 1993 and in Cartagena, Colombia, in June 1994.  A
workshop is scheduled to be held in Thailand in March 1995 as a contribution
to capacity-building.

33.  The Senior Advisers to ECE Governments on Science and Technology, one of
the principal subsidiary bodies of the United Nations Economic Commission for
Europe, have established and are maintaining an inventory of existing safety
guidelines in biotechnology; it includes existing laws and regulations and,
where relevant, any planned measures in order to identify developments and
national experiences gained in this field.  To date, the secretariat has in
its possession national submissions, and in some instances reference material,
from 29 Governments as well as from UNIDO, the Commission of the European
Communities and OECD.  A compilation of the most recent summaries of national
submissions for the inventory in the form of a publication for wider
dissemination is in preparation.  In a related development concerning
protection of water, recommendations to ECE Governments on the prevention of
water pollution from hazardous substances adopted in March 1994, requires,
inter alia, the setting of emission limits based on best available technology
from industries that manufacture and process microorganisms and viruses with
in vitro recombined nucleic acids.

     5.   Programme area E:  Establishing enabling mechanisms for the
          development and the environmentally sound application of
          biotechnology

     Objectives:

          (a)  Awareness-building and public education;

          (b)  Strengthening endogenous capacities of developing countries
     including employment opportunities for women;

          (c)  Consolidation of efforts;

          (d)  Socio-economic impacts of new biotechnology on conventional
     production systems;

          (e)  Contribution of indigenous peoples and their share in economic
     and commercial benefits arising from biotechnology;

          (f)  Intellectual property rights with respect to biotechnology and
     bioresources;

          (g)  Increase access both to existing information about
     biotechnology and to facilities based on global databases;

          (h)  Helping to create a favourable climate for investments,
     industrial capacity-building and distribution marketing;

          (i)  Encouraging the exchange of scientists among all countries;

          (j)  Enhancing existing efforts at the national, regional and global
     levels;

          (k)  Providing the necessary support for biotechnology, particularly
     research and product development, at the national, regional and
     international levels.

34.  Through its network of affiliated centres, ICGEB is in a position to
guarantee to developing countries an assistance following the "bottom-up"
approach, financing collaborative research projects submitted by national
institutions in the developing country itself.  At the same time, through its
pre-doctoral and post-doctoral fellowship programmes, aimed at training in the
best possible environmental and scientific facilities, the Centre ensures the
transfer of technology to its member countries.  Trainees are expected to
return to their country of origin and from there to provide a research channel
that continues to operate between ICGEB and the trainee's own country through
collaborative research projects.  The training activities of ICGEB include a
short-term programme that allows scientists from all member countries to
participate in short courses, seminars and symposia on very advanced and
specific scientific topics in biotechnology.


35.  UNIDO uses its comparative advantage in its close association with the
ICGEB as the only operating laboratory in the field of genetic engineering and
biotechnology established within the auspices of the United Nations system and
an important, recognized resource for developing countries.  Collaborative
activities are aimed at the global, regional and national levels in an
integrated programme approach involving biosafety, technology transfer,
investment strategies, and management, including development, acquisition and
commercialization of biotechnology products, services and industrial
processes.

36.  UNIDO and ICGEB networks include the global bioinformatics network on
molecular biotechnology (ICGEBNet), biosafety (BINASNet), lactic acid and food
fermentation technology (LABNET) and bioconversion and mushroom technology
(MUSHNET).  In addition,  UNIDO, in cooperation with UNDP and FAO, promotes
regional bioinformatics networks in Asia and, with UNDP and UNESCO, a
bioinformatics network in Latin America.  In support to the biotechnology
networks, UNIDO and ICGEB act as a repository of information by gathering and
collating information on research and development activities in member States;
hosting information on commercial products and technologies developed by
institutes in Member States; and monitoring matters related to patent laws,
release of genetically engineered micro-organisms/products and biosafety
legislation.

37.  Benefiting from the Organization's expertise and experience in
telecommunication and information technology, as well as extensive
computerized information systems that include the Industrial Technology
Information Bank (INTIB), UNIDO promotes electronic networking to strengthen
technical cooperation among developing countries.  Through regional network
nodes, it is possible to provide developing countries (network members) with
better access to other regional and international databases on biotechnology
and related subjects.

38.  Working in collaboration with the Carl Duisberg Gesellschaft-South East
Asia Program Office (CDG-SEAPO) in Thailand and the Philippines, UNIDO has
seed money to establish Quality Control and Training Centres (QCTCs) in
selected developing countries; the QCTCs will focus on training in
biotechnologies, on business management skills, on entrepreneurship training,
and on increasing opportunities for women to be actively involved in
small-scale enterprise development.  The QCTCs are expected to be
self-sustaining through income- generation from the private sector.

39.  A severe lack of information in developing countries on progress in
biotechnology and its potentials for commercialization is a major stumbling-
block preventing policy makers in these nations from venturing into new
channels for advancement.  To help countries overcome the barrier, UNIDO
directs information to developing countries concerning recent developments and
applications of the technology, information on patents and intellectual
property rights, and relevant institutional news in its quarterly journal
Genetic Engineering and Biotechnology Monitor.  In tandem with the Monitor, a
newsletter specifically concerned with biotechnology in relation to Agenda 21
has been published since the time UNIDO was designated to be task manager for
chapter 16.  This newsletter, called Agenda 21 Biotechnology Watch, promotes
information exchange and stimulates a regular flow of information on the
United Nations system-wide implementation of Agenda 21 in the environmentally
sound management of biotechnology.  Other newsletters entitled LABNET and
MUSHNET are issued to disseminate information to developing countries
concerned with improvements in traditional food fermentation technologies and
with bioconversion of waste materials for mushroom production, respectively.

40.  As part of UNCTAD's work on the Advanced Technology Assessment System
(ATAS), the 1992 issue of the ATAS Bulletin covered tissue culture, among a
wider spectrum of technologies, in focusing on food production in assessing
the scientific capacities of developing countries. 


41.  UNEP supports major training programmes in the sustainable use of plant,
animal and microbial resources, the application of relevant technologies and
in biotechnology safety.  The latter courses are conducted in collaboration
with sister United Nations organizations in order to build related
professional and institutional capabilities in the assessment and application
of environmentally sound biotechnologies for sustainable development.  In
addition, UNEP continually strengthens and expands the regional MIRCENs
network.  Through various national, regional and global level expert
consultations and conferences that involve the public and private sectors and
non-governmental organizations, FAO has been increasing the awareness of the
challenges and opportunities of modern biotechnologies at various levels.  The
regional biotechnology networks sponsored/supported by FAO in different
regions are based on the spirit of TCDC and inter-country cooperation and
promote exchange of information, expertise and techniques.  Regional training
courses on biotechnology and joint research on common topics are the main
features of these collaborative networks.

42.  The FAO draft Code of Conduct on Biotechnology has an elaborate coverage
of the intellectual property rights issue and its impact on information,
technique and product sharing.  FAO promotes a balanced approach between Plant
Breeders' Rights and Farmers' Rights.  The implementation of Farmers' Rights
is currently being negotiated by FAO member countries through the Commission
on Plant Genetic Resources.

43.  Within the framework of the Committee of Experts on Biotechnological
Inventions and Industrial Property, the International Bureau of WIPO presented
suggested solutions concerning industrial property protection of
biotechnological inventions.  Its suggested solutions include processes for
the creation or modification of living organisms and biological material
(process patents) and natural products, living or non-living, which may be the
results of biotechnological processes (product patents).  There are altogether
16 such suggested solutions.

44.  To address the diversification of the chemical industry to include new
biotechnology products and services, a regional networking system concerned
with bio-botanical pesticides has been set up in Asia to gather and
disseminate information on biopesticides.  In addition to information
exchange, a North-South cooperation has been initiated, in cooperation with
UNESCO and the International Union of Pure and Applied Chemistry (IUPAC), for
training in safety and environmental protection in chemical, pharmaceutical
and  biotechnological research.

45.  Within the framework of collaboration between UNDP, UNESCO and ICSU in
the African Biosciences Network (ABN), support has been provided to encourage
research activities and training activities in the biosciences and
biotechnologies throughout Africa.

46.  The International Fund for Agricultural Development (IFAD) increasingly
supports, through its Technical Assistance Grants Programme for Agricultural
Research and Training, new opportunities offered by biotechnology-based
options to increasing the resilience of farming systems to adverse external
production constraints, especially under resource-poor conditions in which
traditional extensive farming and livestock systems cannot be sustained. 
IFAD's support for such research aims at the generation of technologies that
allow traditional crops/commodities produced by resource-poor farming systems
to transcend conventional threshold levels of yield, improve tolerance to
environmental stress factors as well as resistance to pests and diseases that
currently undermine the productive capacity of poor smallholders.  In
elaborating the applications of biotechnology, the Fund supports an emphasis
that goes beyond one shot increases in yields/productivity to also address
issues of stability and sustainability, while carefully considering risks
inherent in bio-engineering.

47.  An international meeting on the role of patents in biotechnological
inventions, one of the fastest-growing areas of patent applications, was held
in November in New Delhi, India, with experts stressing the need to strengthen
the information system in this field.  The meeting was organized by the World
Intellectual Property Organization (WIPO).  The topics discussed included the
role of intellectual property in promoting technological innovations, aspects
of legal protection, micro-organism deposit systems and application of patents
and special features of licensing.

48.  Finally, UNDP's recent emphasis on sustainable human development
encourages the participatory involvement of local organizations and people in
the planning and implementation of scientific endeavour, and seeks to avoid a
heavy dependence on transfer of technology.  This emphasis is shared by other
United Nations organizations.  Thus, in general, it is likely that in the
future, biotechnology will be part of a broader multisector initiative rather
than a "stand-alone" project.


                                   Annex II

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