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E/CN.17/1997/2/Add.15 |
Economic and Social Council
Distr. GENERAL
21 January 1997
ORIGINAL: ENGLISH
COMMISSION ON SUSTAINABLE DEVELOPMENT
Fifth session
7-25 April 1997
Overall progress achieved since the United Nations
Conference on Environment and Development
Report of the Secretary-General
Addendum
Environmentally sound management of biotechnology *
(Chapter 16 of Agenda 21)
(* The report was prepared by the United Nations Industrial
Development Organization (UNIDO) as task manager for chapter 16 of
Agenda 21, in accordance with arrangements agreed to by the Inter-
Agency Committee on Sustainable Development (IACSD). It is the result
of consultation and information exchange between United Nations
agencies, international and national organizations, interested
government agencies and a range of other institutions, individuals and
major group representatives.)
CONTENTS
Paragraphs Page
INTRODUCTION ................................................ 1 - 4 3
I. PROGRESS ACHIEVED IN THE IMPLEMENTATION OF THE
OBJECTIVES OF THE SELECTED TWO PROGRAMME AREAS ........ 5 - 17 4
A. Establishing enabling mechanisms for the
development and environmentally sound application
of biotechnology .................................. 6 - 13 4
B. Enhancing safety and developing international
mechanisms for cooperation ........................ 14 - 17 6
II. TRENDS RELEVANT FOR THE FURTHER IMPLEMENTATION OF THE
OBJECTIVES SET OUT IN CHAPTER 16 OF AGENDA 21 ......... 18 - 21 7
III. CONSTRAINTS AND UNFULFILLED EXPECTATIONS .............. 22 - 26 8
IV. EMERGING PRIORITIES ................................... 27 - 29 9
INTRODUCTION
1. The present report reviews progress made in the implementation of
the objectives set out in chapter 16 (Environmentally sound management
of biotechnology) of Agenda 21, 1/ taking into account the decision
taken by the Commission on Sustainable Development on that subject at
its third session in 1995. Those objectives are set out relative to
the following five programme areas: (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
environmentally sound application of biotechnology.
2. Biotechnology can contribute to sustainable development by
improving food production and feed supply, health care and
environmental protection. Information provided by national
Governments to the Commission shows that many developed and developing
countries are undertaking efforts in biotechnology research and
development and are establishing policies related to the sustainable
use and management of biotechnologies. The number of private-sector
companies involved in biotechnology research and development or
showing a vital interest in its results is growing.
Box 1. Interests of countries in biotechnology use is growing
In 1995, the Health and Safety Executive of the United Kingdom of
Great Britain and Northern Ireland had notification of 470 centres
that are carrying out activities involving the contained use of
genetically modified organisms. There are also many large and
multinational companies with substantial interests in biotechnology,
and in addition about 150 small and medium-sized enterprises whose
operations are based on biotechnology research and development.
Between 1984 and 1993, the National Centre for Genetic Engineering
and Biotechnology of Thailand allocated US$ 9 million to university
research and development in biotechnology, inter alia, to support the
use of biopesticides and reduce the use of chemical fertilizers by
promoting the use of biofertilizers.
3. Several United Nations bodies and other international
organizations have strengthened their biotechnology and related
support programmes or developed new initiatives to assist efforts
being undertaken by developing countries and economies in transition.
Through cooperation programmes, the access of those countries to
biotechnology information and applications has improved, and the
adaptation of biotechnological solutions to the conditions of
particular clients has been facilitated.
4. The increasing recognition that biotechnology can provide
solutions for many problems fundamental to sustainable development
makes it essential to establish national legislation to ensure the
adequate protection of human health and the environment in connection
with the contained use and release of genetically modified organisms
resulting from modern biotechnologies. Moreover, it calls for
internationally agreed guidelines or principles of risk assessment and
risk management to be applied in the development, transboundary
movement and use of biotechnology solutions.
I. PROGRESS ACHIEVED IN THE IMPLEMENTATION OF THE
OBJECTIVES OF THE SELECTED TWO PROGRAMME AREAS
5. Consistent with the conclusions of inter-sessional meetings on
issues related to the environmentally sound management of
biotechnology, and the decisions on biotechnology adopted by the
Commission at its third session, in 1995, progress in two programme
areas is reported on below.
A. Establishing enabling mechanisms for the development and
environmentally sound application of biotechnology
6. Important for the sustainable use of biotechnologies is the
establishment of an effective and transparent national decision-making
structure to deal with the legal and policy issues related to the safe
and sound management of biotechnologies. An increasing number of
countries have developed or are in the process of developing
regulatory oversight systems for biotechnology applications that
contain guidelines or principles on biotechnology risk assessment and
risk management. In order to take account of public concerns relative
to safeguarding environmental health and safety in the use of modern
biotechnologies, efforts are being made to ensure active participation
by the public at large in the discussion on and implementation of
those policies.
Box 2. Establishing biosafety mechanisms at the national level
The purpose of the Finnish Gene Technology Act is to promote the
safe and ethically acceptable use of gene technology. The legislation
contains principles on biotechnology risk assessment and management.
Consultations with public and private-sector groups and with
communities is a key feature.
In Brazil, specific legislation was sanctioned in 1995 and a
number of biosafety regulations were adopted related to biosafety in
laboratories and the release of genetically modified organisms into
the environment. In order to enhance awareness and transparency
several TV programmes are devoted to the potential benefits and risks
arising from the application of biotechnology, taking into account
ethical and cultural considerations.
Malaysia's biosafety guidelines to control the release of
genetically modified organisms and biotechnology products are in the
final stage of preparation. Mass media, including newspapers, TV and
radio, are actively involved in awareness-raising and education of the
public on biosafety issues.
7. The ways and extent to which government policy is used to support
or promote biotechnology vary considerably among countries. In
developed countries, policy instruments are mainly aimed at
strengthening the competitive positions of those countries in the area
of biotechnology, and involve science and technology, industrial,
trade and economic policy, and government interaction with the private
sector. In view of international competition Governments are
increasingly becoming willing to intervene in the market. In the
majority of developing countries, the question of national policy for
biotechnology is singularly important. In many instances, policy
initiatives are already being undertaken with varying degrees of
success.
8. A major policy challenge concerns the ability to be selective in
the promotion of biotechnology so as to optimize social and economic
returns on scarce resources in ways that are compatible with overall
economic policies and development strategies. Policy makers in
developing countries are faced with the dilemma of choosing between
long-term solutions through technology transfer and capacity-building,
including through cooperative arrangements with developed countries,
and short-term solutions utilizing conventional methods and
improvements of their information and management practices.
9. Essential for success in developing capabilities in the safe and
sound use and management of biotechnologies appear to be the
establishment of relevant research and development programmes,
fostering research potential through a steady supply of qualified
personnel, making investment capital available and providing private-
sector incentives to invest in biotechnology.
Box 3. Capacity-building in biotechnology
The University of Havana, Cuba, offers postgraduate studies in
biosafety, and a number of universities in Bolivia implement training
programmes in biotechnology. Malaysia is making available research
and development results in biotechnology produced in public
institutions to the private sector at no cost in order to strengthen
the linkages between research and development activities and the
commercialization of biotechnologies, and to encourage collaboration
between the public and private sectors.
10. Lack of human and material resources can to some extent be
compensated through building up research networks as a means of
increasing critical mass. Extensive use of communication and
multimedia technologies can enhance the effectiveness of such
networks, and in addition can provide a cost-effective means of
upgrading scientific and technological skills.
11. Facilitator mechanisms effecting the transfer of proprietary
technologies to public and private institutions in the developing
world are also likely to have significant impacts on upgrading
scientific and technological capacity.
12. Intellectual property rights and biosafety play a key role in
building long-term competitive advantage. National policies to
protect proprietary rights in intellectual property are important to
stimulate research and development in biotechnology, attract private-
sector investment and promote biotechnology transfer, while ensuring
that public health and environmental safety are not compromised.
13. At the international level, aid programmes have reduced their
commitment to the development of long-term training and research
efforts in the agricultural and medical sectors. Hence, the success
of international programmes depends on ensuring that the cycle of
market research, priority setting, strategic and applied research,
technology transfer and feedback remains operative.
B. Enhancing safety and developing international
mechanisms for cooperation
14. The need for further efforts leading to international agreement on
principles to be applied in risk assessment and the management of all
aspects of biotechnology is widely recognized. The report of the
European Community to the Commission on Sustainable Development at its
third session, for example, stated that 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
better position to accept the benefits and risks of biotechnology. A
considerable number of non-governmental organizations, women groups
and indigenous people in both developed and developing countries have
expressed concern that the promotion of biotechnology is quite
undesirable without some international mechanism in place to protect
people from possible adverse effects resulting from genetically
altered foods and animals, as well as from disadvantages that a
biotechnology-driven market might bring to small farmers in developing
countries.
15. Disparities in the definition of regulated items and the scope of
regulations and assessment procedures in different countries may
potentially compromise public health and environmental safety. In
some cases, it may also lead to unfair trade practices. International
cooperation is therefore essential in minimizing regulatory
contradictions among individual national systems and ensuring the
harmonization of risk-assessment procedures to the extent possible.
Such cooperative efforts are already under way. The United Nations
Industrial Development Organization (UNIDO), for example, has
established the Biosafety Information Network and Advisory Service.
Its cooperation with the Expert Group for Harmonization of Regulatory
Oversight in Biotechnology of the Organisation for Economic
Cooperation and Development has resulted in the establishment of an
integrated database on biotechnology regulations and risk-assessment
procedures.
16. In parallel, the Conference of the Parties to the Convention on
Biological Diversity, at its second meeting in Jakarta in November
1995, decided to establish an open-ended ad hoc working group of
government-designated experts to develop a protocol on biosafety in
the field of the safe transfer, handling and use of living modified
organisms. The protocol is to have a specific focus on the
transboundary movement of any living modified organism resulting from
modern biotechnology that might lead to adverse effects on the
conservation and sustainable use of biological diversity, and is to
set out for consideration an appropriate procedure for advance
informed agreement. During the Jakarta meeting, it was also agreed
that the UNEP guidelines may be used as an interim mechanism during
the development of the protocol and to complement it after its
conclusion. An open-ended ad hoc working group of experts established
under the Convention on Biological Diversity met for the first time at
Aarhus, Denmark, from 22 to 26 July 1996, to discuss the elements and
structure of the protocol.
Box 4. Initiative of the United Nations Environment
Programme (UNEP) on international biosafety
guidelines
A UNEP-led initiative resulted in the adoption of the
International Technical Guidelines for Safety in Biotechnology by a
global consultation of government-designated experts held at Cairo in
1995. The Guidelines were formulated on the basis of common elements
and principles derived from relevant national, regional and
international instruments, regulations and guidelines, and drew upon
experience already gained through their preparation and
implementation. An international workshop to follow up on the
Guidelines, which was held in Buenos Aires from 31 October to 1
November 1996, adopted recommendations on capacity-building related to
biosafety.
17. Finally, another notable development has been the Fourth
International Technical Conference for Plant Genetic Resources, which
was held at Leipzig from 17 to 23 June 1996. The Conference was
convened by the Food and Agriculture Organization of the United
Nations (FAO) with the intention of translating the relevant parts of
Agenda 21 and the Convention on Biological Diversity into a global
plan of action. The Conference resulted in a plan of action that
includes some 346 recommendations derived from a background report
entitled "State of the world's plant genetic resources". It also
resulted in a declaration on conservation and sustainable utilization
of plant genetic resources for food and agriculture. The declaration
formulates general rules and principles on access to and conservation
and use of plant genetic resources.
II. TRENDS RELEVANT FOR THE FURTHER IMPLEMENTATION OF THE
OBJECTIVES SET OUT IN CHAPTER 16 OF AGENDA 21
18. A growing number of developing countries and economies in
transition have realized the considerable scope that exists for
achieving productivity gains, improvement in the quality of food and
agricultural products, and conservation of the environment by using
modern biotechnologies as an adjunct to existing technologies and
methods. Progress is becoming noticeable particularly where efforts
have been geared to channel an important part of biotechnology
capacity-building towards the effective exploitation of existing
knowledge. That in no way diminishes the need for developing
countries to build domestic skills and capabilities in the
biosciences; on the contrary, it is in countries that have the
strongest science and technology base that the use, assimilation and
adaptation of existing knowledge becomes part of the cumulative
learning process leading to upgrading their research and development
capability.
19. A number of countries have achieved significant progress through
the successful implementation of industrial and technology policies.
For example, the Asian newly industrialized countries have been
particularly skilful in deploying industrial policy to promote
commercial biotechnology. They use grants, direct capital investment
and fiscal stimulants, and support skill-building and downstream
development. Some countries have made systematic use of foreign
technology licensing and the repatriation of scientists trained abroad
to strengthen their relatively weak research bases. In Latin America,
most Governments have tended to confine their activities to research
and development support. Although some of the larger countries are
beginning to develop more comprehensive approaches to bio-policy, it
will be some time before that shift begins to have an impact on
society and the economy.
20. Genome research in key species has generated a large amount of
information and spin-off technologies in the public domain that are
increasingly being utilized in target-oriented research relevant to
developing countries. In parallel, the proliferation of electronic
information accessible on the Internet is beginning to have major
beneficial impacts on research and education.
21. At the international level, in vitro micropropagation and
recombinant DNA technologies for the conservation and exchange of
genetic diversity of crops important to the developing world have
already been transferred to national programmes, mainly through
Consultative Group on International Agricultural Research centres.
Similarly, genetic engineering has been successfully deployed in
research programmes for diagnostics, drug and vaccine development of
the World Health Organization; the International Green Cross; the
UNDP/World Bank/WHO Special Programme for Research and Training in
Tropical Diseases; and the International Centre for Genetic
Engineering and Biotechnology.
III. CONSTRAINTS AND UNFULFILLED EXPECTATIONS
22. To date, in many developing countries, the actual contribution
that biotechnology can make to solve fundamental problems of
development and environment remain below the expectations foreseen by
the United Nations Conference on Environment and Development. As for
the ground-level social benefits of biotechnology, they have yet to
make themselves widely felt; that is not surprising, however, in view
of the fact that health care and agricultural biotechnology are only
now appearing in the market place, even in the industrialized world.
23. A considerable number of developing countries still lack the level
of biotechnology capacity required to undertake research and
development in biotechnology or to fully benefit from biotechnological
solutions available in the market. The obstacles to building up
biotechnology capability and capturing its social and private returns
still remain in most developing countries. Early expectations that
biotechnology would make a significant contribution to achieving
sustainable development while safeguarding the environment are being
fulfilled only slowly. Constraints include: (a) scarcity of human
and financial resources; (b) low institutional capacity; (c) lack of
coherent realistic policies in some countries, and on occasions lack
of political will; and (d) inadequate awareness and understanding of
the potential benefits and risks of the technology, as well as of the
requirements for its environmentally sound management.
24. The observable reduction of international funding for research and
programmes addressing problems of the developing world is a trend
affecting many sectors. Indeed, available information indicates
levels of financial support far below those that are minimally
required to enable developing countries to participate in and benefit
from the use of biotechnology.
25. There is growing concern among several developing countries about
the increasing interest of foreign private companies in using the
knowledge of indigenous people for private gain. They argue that the
Trade-Related Intellectual Property Rights provisions of the World
Trade Organization work to the advantage of private companies and
laboratories, who are able to commercialize such products as medicine
or seeds based on the knowledge of indigenous people or communities.
On the other hand, intellectual property rights systems deny
protection to the knowledge and innovations of indigenous people or
communities because it is deemed to be in the public domain and
therefore to be freely available. Accordingly, the need to safeguard
private investment through strong intellectual property regimes must
be compensated by workable arrangements that ensure equitable sharing
of socio-economic benefits with the developing world.
26. The negotiations under the Convention on Biological Diversity on
internationally agreed guidelines or principles of risk assessment and
risk management to be applied in the development, transboundary
movement and use of biotechnological solutions has been slow because
of the differences in national interests. Some countries are in
favour of limiting the scope of the proposed protocol mainly to the
transboundary movement of living modified organisms. They argue that
such a protocol should aim at greater harmonization of existing
regulations and accept the concept of substantial equivalence. Other
countries and a number of non-governmental organizations favour a
broader scope, including provisions on the domestic handling and use
of transgenic organisms, as well as provisions on liability and
compensation resulting from malpractice.
IV. EMERGING PRIORITIES
27. Conclusion of the negotiations on a biosafety protocol under the
Convention on Biological Diversity will be an important step forward.
In following up its implementation at the national level, the
establishment of a participatory mechanism facilitating effective and
constructive interaction between the private and public institutions
(industry associations, United Nations and other international bodies,
non-governmental organizations etc.) aimed at considering
controversial issues and resolving conflicts of interest will be
useful. Such mechanism may have a profound effect in assuring public
confidence and providing useful inputs, inter alia, to the Commission
on Sustainable Development, the Conference of the Parties to the
Convention on Biological Diversity and other international forums. In
establishing such a mechanism, the experiences gained by the ad hoc
working group on biosafety of UNIDO/UNEP/WHO/FAO may be useful.
28. Institutional capacity-building and networking should be promoted
by national Governments to ensure the promulgation and implementation
of national policies for access to genetic resources, biosafety and
intellectual property protection, along with the requisite capacity
for implementation.
29. Developing countries should set up mechanisms to facilitate the
evaluation of research and development activities in biotechnologies
and the commercialization of those technologies, as well as to assess
their ecological, health and socio-economic and ethical implications
in specific contexts.
Note
1/ Report of the United Nations Conference on Environment and
Development, vol. I, Resolutions Adopted by the Conference (United
Nations publication, Sales No. E.93.I.8 and corrigendum), resolution
1, annex II.
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Date last posted: 10 December 1999 17:25:35
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