International Trends
in Modern
Biotechnology: Entryby and Implications
for African Countries

John Mugabe

ATPS SPECIAL PAPER SERIES No. 15

Published by the African Technology Policy Studies Network, P.O. Box 10081, 00100
General Post Office, Nairobi, Kenya.

© 2003 African Technology Policy Studies Network (ATPS)

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ABOUT THE AFRICAN TECHNOLOGY POLICY STUDIES NETWORKThe African Technology Policy Studies Network (ATPS) is a multi-disciplinary network of researchers,
policy makers, actors in the private sector and other end users interested in generating, promoting
and strengthening innovative science and technology policies in Africa. With a regional secretariat in
Nairobi, the network operates through national chapters in 17 countries, with an expansion plan tocover the entire sub-Saharan Africa.
One of the objectives of the network is to disseminate research results to policy makers, legislators,
the organized private sector, civil society, mass media and farmers’ groups through publications,dialogue and advocacy. Among its range of publications are the Working Paper Series (WPS),
Research Paper Series (RPS), Special Paper Series (SPS) and the Technopolicy Briefs.
Papers published under the ATPS Special Paper Series are those commissioned as concept
papers, think pieces, leading conference papers and keynote addresses. In keeping with
our knowledge brokerage function, ATPS publishes, with permission of the author(s) or
journal editors, papers (published or unpublished) produced by distinguished academics/
researchers for a different purpose but judged by ATPS to be of excellent quality. Thesepapers address significant policy questions relevant to the work of ATPS and/or support
the Southern voice or an African perspective. We also consider theoretical papers that
advance our knowledge of science and technology policy issues.
ATPS is supported by a growing number of donors including the International Development ResearchCentre (IDRC), the Carnegie Corporation of New York, the Rockefeller Foundation, the World Bank,
the OPEC Fund, Ford Foundation, Coca-Cola Eastern Africa, the African Development Bank, InfoDev,
and the Royal Dutch Government.

Table of Contents
List of Abbreviations and Acronyms
List of Tables
Introduction
1. International biotechnology development
1.1.
Trends in research, development and commercialization
1.2.
The Institutional landscape
2. Biotechnology in developing countries
2.1
Overview of biotechnology R&D in Africa
2.2.
Biotechnology R&D in Asia: some examples
2.3.
Biotechnology in Latin America
3. International public policy issues
3.1.
Public perception
3.2.
Regulatory Approaches and Capability
4.
The way forward
4.1.
Build public confidence and participation
4.2.
Build and utilize public R&D capacity
4.3.
Establish and apply regulatory instruments
4.4.
Build public-private R&D partnerships
5. Conclusion

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References

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List of Abbreviations and Acronyms
AGERI
APHIS
BSE
CAS
CIGB
CMI
CONABIACTNBio
CVL
DAB
DNA
EPA
EPSPS
EU
FDA
GEF
GMAC
GMO
HGS
HIV/AIDS
ICGEB
IPB
ITSTC
KARI
MAbs
NBC
NBFs
NCBP
R&D
SAGENE
SAGPyA
SSTC
UK

Agricultural Genetic Engineering Research InstituteAnimal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy
Chinese Academy of ScienceCentre for Genetic Engineering and Biotechnology
Centre for Molecular Immunology
National Biosafety Committee
National Technical Biosafety Committee
Central Veterinary Laboratory
Drug Administration Bureau
Deoxyribonucleic Acid
Environmental Protection Agency
Enolpyruvateshikimate-3-Phosphatesynthase
European Union
Food and Drug Administration
Global Environment Facility
Genetic Manipulation Advisory Committee
Genetically Modified Organisms
Human Genome Sciences
Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome
International Centre for Genetic Engineering and Biotechnology
Institute of Plant Breeding
Institute for Tropical and Sub-Tropical Crops
Kenya Agricultural Research Institute
Monoclonal Antibodies
National Biosafety Committee
National Biotechnology Funds
National Committee on Biosafety of the Philippines
Research & Development
South African Committee for Genetic Experimentation
Secretary of Agriculture, Livestock, Fisheries and Food
State Science and Technology Commission
United Kingdom

i

UNEP
UPLB
USA
USAID
ZYMV

United Nations Environmental Programme
University of the Philippines in Los Banos
United States of America
United States Agency for International Development
Zucchini Yellow Mosaic Potyvirusii

List of Tables

Table1: Genetically Modified Crops on the Market, 1999
Table2: Applications Approved for Field-testing or Commercialization oftransgenic plants

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Introduction

This paper maps global trends in the development, commercialization and application of modern
biotechnology and discusses their implications for African countries. It analyzes different policies,
laws and agencies that some development countries are establishing to respond to opportunities
and challenges that develop the technological system are creating. The paper is stimulated by avariety of factors. First, rapid scientific advances in such areas as genetic engineering and genomics
are opening new technological options to address some of the developing world’s food production,
human health and environmental degradation challenges while at the same time they are generating
concerns about potential negative impacts on humanity and nature. Expectations of benefits growas uncertainty of potential risks increases. Developing countries’ policy-makers are thus confronted
with the challenge of ensuring that their countries share benefits of the technology while at the sametime managing its risks, even anticipated and perceived ones.
Second, the adoption of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
and its anticipated entry into force create new international legal obligations on the part of developing
countries. For example, these countries will now need to establish biotechnology risk assessment
regimes, including scientific and technological competencies to manage the development, transfer
and handling of living modified organisms. The effectiveness of their efforts will to a large measuredepend on how well they engage in technology forecasting, anticipate new biotechnology processes
and upgrade their scientific and technological infrastructure. Risk assessment and management
need to be an integral part of biotechnology development. It is those countries that are able toengage effectively in developing and applying the technology that are able to assess and manage its
risks.
Third, there is a growing interest and investment by developing countries in biotechnology. Some ofthese countries are now exporters of genetically modified or living modified organisms. In order toenlarge their economic competitiveness they need to anticipate and invest in new technologicaltrajectories while also responding to risk concerns. Monitoring biotechnology trends should constitutea significant measure of their strategic investment plans and programmes.This paper identifies
those technological pathways that African countries should monitor over the coming years.
The first section is about the evolution and growth of modern biotechnology. It also outlines some of
the key features of the technology and main international public and private sectors’ actors in thedevelopment and commercialization of the technology. The second is an overview of the status of1

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ATPS SPECIAL PAPER SERIES N O. 15

biotechnology R&D in developing countries. The third discusses policy measures that Africancountries should put in place for them to benefit from advances in biotechnology.

1.

International Biotechnology Development

1.1 Trends in Research, Development and Commercialization
Modern biotechnology is a cluster of in vitro nucleic acid techniques, including recombinant
deoxyribonucleic acid (r-DNA) and monoclonal antibody that use living organisms, or their derivatives,to make products or processes. It involves genetic transformation of living matter. Rapid advances inthis technology are associated with major scientific breakthroughs of the mid-1970s. Growth inscientific understanding of the nature and functional uses of deoxyribonucleic acid (DNA) made it
possible for scientists at Stanford and California universities in the United States of America (USA) toisolate genetic information from a gene of one organism and to insert it into another organism.
Essentially DNA from one organism was successfully transferred to another. This is what is now
commonly referred to as recombinant DNA technology. The technology has made it possible toincorporate genes from microorganisms into plants, and from plants into animals.
Another scientific breakthrough that formed modern biotechnology is the production of monoclonal
antibodies (MAbs) through cell fusion by the UK’s Medical Research Council’s laboratories in 1975.
Prior to this breakthrough pure antibodies could not be produced by conventional techniques. The
conventional method of producing anti-bodies for diagnostic and therapeutic purposes is to injectan antigen into an animal to stimulate an immune response and collect antiserum from the animal.
This method has a number of limitations including contamination of the antiserum and the limited
supply of requisite antisera.The method is also time consuming and relatively expensive. MAb
technology has made it relatively easy to identify pathogens and to deliver drugs to destroy pathogenic
cells in the human body. They have increased the application of immuno-assays in the diagnosis ofbacterial infections that account for at least 30% of deaths in developing countries.
The combination of DNA and MAb technologies has revolutionized industrial agriculture andpharmaceuticals and created a wide range of new opportunities for fighting human and livestock
diseases. In the early 1980s these technological opportunities were widened by the cloning of acomplete bacterial antibody molecule. A United States (US) based firm Genentech developed andreconstituted bacteria protein chains and produced antibody genes1. These developments sparked
renewed interest in bioprocessing, particularly for the formation of complex molecular structures

1

Klausner, A., ‘Genentech Makes Monoclonal Precursors From E. Coli’ in Bio/Technology, July 1983, p. 396-397.

3

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ATPS SPECIAL PAPER SERIES N O. 15

such as antibodies and proteins. Novel bioprocessing techniques were developed for large-scale
production of biotechnology products.
The 1990s witnessed a new wave of scientific advances in biotechnology.The mapping andsequencing of the human genome have given rise to a new scientific enterprise: genomics. Genomics
is “the development and application of research tools that uncover and analyze thousands of different
molecules at a time”.2 It has granted scientists and pharmaceutical companies unprecedented
access to the molecules of life. Through it, massive amounts of biological information can beconverted into electronic form, linking life sciences to information sciences. Human genome map islikely to serve as a guide in the exploration of causes of diseases, and will accelerate developmentof treatments and cures for many illnesses. By identifying specific genes linked to diseases, scientists
and companies will develop genetic tests that can help prevent the onset of illness. Biotechnology
firms in the industrialized world are investing considerably in developing treatments for diseases
linked to single genes, such as cystic fibrosis. Human Genome Sciences (HGS) one of the world’s
leading genomics companies has six medicines advanced to human trials and to be potentiallysubmitted to the U.S. Food and Drug Administration for marketing approval around 2005. It has
churned out gene-based drugs and therapies to heal chronic wounds, lessen cancer drugs’ side
effects, and boost the immune system. Prospects of winning wars against such diseases as cancer,
tuberculosis, and HIV/AIDS are being enlarged.
Related to genomics is proteomics, the study of how proteins are made, their identification andfunctioning in the cell is set to be next frontier science in the 2000s. It holds promise of potentiallylifesaving medical treatments. This science enables scientists to uncover information on how genes
are related to biological functions and diseases. Clinical proteomics is revolutionizing thedevelopment of biomarkers for drug development. A protein floating in blood can help predict a
disease.3
These scientific discoveries and their commercial application have formed the biotechnology industry.
Large corporations in the USA, Europe and Asia have made major investments to adapt thesetechnologies to the production of new pharmaceutical drugs and improved plant varieties. In thepharmaceutical sector there are currently more than 100 biotechnology drugs and vaccines approvedby the FDA and more than 350 in the pipeline. The first gene therapy was approved in 1990 to treat
Severe Combined Immune Deficiency. Gene therapy techniques for cystic fibrosis have also been
approved. DNA probes and MAb diagnostics constitute a large part of biotechnology, at least half ofcommercialized biotechnology-derived products. By 1996 there were at least 220 diagnostic kits

2

Zweiger, G., 2001. Transducing the Genome: Information, Anarchy, and the Revolution in Biomedical Sciences, p.xii. McGrawHill, New York.
3
New York Academy of Sciences, Academy Update, March/April 2001.

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

5using monoclonal antibodies and eight using DNA probes on the market. Total sales for MAb products
were projected at US$ 3,800 in 1998 and US$ 720 million for DNA diagnostics by 2000.
In agriculture, at least 70 genetically modified (transgenic) varieties of crops were registered forcommercial cultivation worldwide in 1999. These include new varieties of cotton, potato, tobacco,
tomato and clove. More than 15,000 field trials have been undertaken globally. New genetic
modifications of more than 100 plant species are growing in laboratories, greenhouses, or in thefield, providing farmers with new agronomic traits, particularly herbicide tolerance and pest resistance.
In 2000 the global area under genetically improved crops was 44 million hectares mainly of maize,soya bean, cotton, canola (rappelled) and potatoes.4 Eighty five percent of this area is in North
America (USA and Canada) and the remaining 15% in developing countries notably Argentina,
China, Mexico and South Africa.
1.2 The Institutional Landscape
Advances in biotechnology have stimulated a variety of institutional arrangements for research,
product development, regulation, and commercialization. The private sector is the leading player inbiotechnology research globally. A growing number of companies dedicated to biotechnology
research have been established in the last decade or so. According to Ernst & Young, in 1997 US
companies invested $9.4 billion in R&D, employed 140,000 people and posted total revenues of $18
billion. At the same time there were 1,036 European companies working in the life sciences,
employing more than 39,000 people directly, with revenues of $3.1 billion and $2.2 billion invested in
R&D.5 In 1999, Monsanto alone allocated some $1.2 billion for biotechnology research while the
National Institutes of Health allocated $15.6 billion in 1999 for basic bioscience research. In 2000
there were more than 1350 biotechnology companies in the world. Their total sale of products wasestimated at US$13.7 billion. More than 60% of these companies were based in the USA andcommanded sales totaling to at least US$ 10 billion.
In general, three categories of private companies have been responsible for the rapid growth ofbiotechnology. First are those companies that had already accumulated substantial capabilities insecond-generation biotechnology, i.e. in fermentation and products like antibiotics, vaccines andenzymes. The second category is those companies that were specifically created to engage inmodern biotechnology and had to build capabilities in such areas as genetic engineering. The last
category comprises of those companies that had no prior engagement in biotechnology but perceived
the potential of the technology and were willing to invest in its development, sometimes with the aimof diversifying their products. All these companies have played a major role in the development ofbiotechnology although their strategies and levels of engagement varied across sectors, countries
and over time. What is, however, common to all of them is that each had direct association with
4

UNDP, 2001. Making New Technologies Work for Human Development, p. 35. United Nations Development Programme, NewYork.
5Ernst and Young, 1998.

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ATPS SPECIAL PAPER SERIES N O. 15

university R&D. The companies that were established to deliberately engage in the technology werein fact born out of university departments by university professors. The other categories of firms reliedon universities as sources of scientific knowledge and information. For example, the traditional nonbiotechnology companies contracted universities to develop and provide to them basic scientificinformation and principles in genetic engineering.
National and international public research organizations are also key players in biotechnology R&D.
In Western Europe, Japan and the US the mid-1980s saw the emerging of biotechnology programmes
to foster national competitiveness in the development and application of the technology. These
programmes were established and managed in national public agencies responsible for researchin agriculture, environment, mining and human health. Cross-sectoral committees were formed toensure that there was coherence and synergy in national biotechnology activities. Austria, Denmark,
United States, and Italy were among the first countries to form national biotechnology coordinating
committees6. Germany developed the first organized government strategy for biotechnology R&D. Itsinstitutional arrangement comprised of a variety of leading science bodies such as the Max Planck
institutes and Frauenhofer institutes. The institutions have dedicated biotechnology research
programmes, and some have accumulated considerable technological capabilities in the area.
They are major sources of scientific knowledge in various aspects of biotechnology.

6

OECD, 1998.

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I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY
Table1:Genetically Modified Crops on the Market,1999
Product traits
Bt crops are protected against insect damage and reduce
pesticide use. Plants produce a protein--toxic only to certain
insects--found in a common soil bacterium called Bacillus
thuringiensis, or Bt.
Herbicide tolerant crops allow farmers to apply a specificherbicide to control weeds without harm to the crop. Gives
farmers greater flexibility in pest management and promotes
conservation tillage.
Disease resistant crops are aimed against destructive
viral plant diseases with the plant equivalent of a ”vaccine”.
High-performance cooking oils maintain texture at hightemperatures, reduce the need for processing and create
healthier food products. The oils are either high oleic or
low linoleic.
In future , high strearate
Healthier cooking oils have reduced saturated fat.
Delayed ripening fruits and vegetables have superiorflavor, color and texture, are firmer for shipping and stay
fresh longer.
Increased-solids tomatoes have superior taste and texture
for processed tomato pastes and sauces.
rBST is a recombinant form of a natural hormone, bovine
somatotropin, which causes cows to produce milk. rBST
increases milk production by as much as 10-15 percent.
It’s used to treat over 30 percent of U.S cows
Food enzymes, including a purer, more stable of chymosinused to curdle milk in cheese production. It’s used to make60 percent of hard cheeses. Replaces chymosin of rennet
from slaughtered calves stomachs.
Nutritionally enhanced foods will offer increased levels ofnutrients, vitamins and other healthful phytochemicals.
Benefits range from helping developing nations meetbasic dietary requirements, to boosting disease-fighting
and health promoting foods.
Source:http://www.bio.org/food&ag/transgenicprod.html

Crops
corn, cotton, potatoes
Future: sunflower, soybean, canola, wheat, tomatoes
soybean, cotton, corn, canola, rice
Future: wheat, sugar beetsweet potato, cassava, rice, corn, squash, papaya
Future: tomatoes, banana
sunflower, peanuts and soybeans

soybeantomatoes
Future: raspberries, strawberries, cherries,
tomatoes, bananas , pineapples
tomatoesrBST (milk production)

chymosin (in cheese)--the first biotechnology product in food
Future: protein enhanced sweet potatoes and rice;high vitamin A canola oil; increased antioxidant fruits
and vegetables

2.

Biotechnology in Developing Countries

The past two decades have witnessed increased investment in biotechnology research anddevelopment (R&D) by a growing number of developing countries. The nature of activities and levels
of investment vary from one country to another, and from one sector to another. These initiatives arecarried through a variety of institutional forms from laboratories in established national agriculturalresearch bodies, national biotechnology centers, national biotechnology programmes managed in
sectoral research agencies, and international research bodies such as those of the Consultative
Group of International Agricultural Researchers (CGIAR).
2.1. Overview of Biotechnology R&D in Africa
African countries can be grouped into four categories in terms of their investment and engagementin biotechnology R&D. The first group of countries is that involved in more sophisticated biotechnology
activities, those pertaining to the development and commercialization of genetically modified
organisms. This group consists of Egypt and South Africa. The second group is those countries
engaged in the research and development of genetically modified organisms, and with some products
at field-testing stage. It includes Kenya, Nigeria and Zimbabwe. The third group is those countries
largely involved in tissue and cell culture applications. This includes Ghana, Tanzania and Uganda.
The last group is of those countries that are not engaged in biotechnology. This group includes
Ethiopia, Rwanda and many of the region’s countries.
South Africa and Egypt are biotechnology leaders in the region. With considerable scientificinfrastructure, the two countries have growing investment in biotechnology and are commercializing
some of their products. South Africa’s biotechnology R&D focus is on genetic engineering of cereals:
barley, lupins, maize, millet, ornamentals, sorghum, soybean, sugarcane, sunflowers, vegetables
wheat, as well as on molecular marker applications of: diagnostic for pathogen detection; cultivar
identification potatoes, sweet potato, ornamentals, cassava, cereals, seed-lot purity testing cereals;
marker assisted selection in maize, tomato, and markers for disease resistance in wheat. The first
field trials for genetically modified crops were initiated in 1990, while conditional commercial release
permits were granted in 1997. The country has now commercialized insect-resistant maize andinsect-resistant cotton. Other genetically modified crops expected to reach the market within thenext couple of years include barley, soya, wheat, and sunflower seed. By end of 2000, 41 GMO fieldtrials had been conducted in South Africa.

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I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

9

The country has enacted legislation to regulate the development, importation and application ofgenetically modified organisms. The Genetically Modified Organisms Act (GMO Act)7 was passed
in 1997, and regulations for its implementation were adopted in 1999. According to the legislation,
no person may import or export from the Republic of South Africa, or develop, produce, use, releaseor distribute any GMO in the Republic of South Africa, other than under a permit for undertaking suchan activity8. Such permit is to be issued after a technical assessment and risk analysis report has
been submitted by the applicant and has been approved by the Executive Council. The GMO
Regulations9 provide that an applicant shall notify the public of any proposed release of GMOs prior
to the application for a permit for such release. Public notifications shall be in the form of a standard
notice published in the printed media informing the public of the intended release10. The South
African Committee For Genetic Experimentation (SAGENE), a scientific advisory committee, hasbeen monitoring and advising on GMO development and release.
Section 2 of the GMO Act defines scope for its application. It provides that the “Act shall apply to thegenetic modifications of organisms; the development, production, release, use and application ofgenetically modified organisms (including virus and bacteriophages); and the use of gene therapy.”
Excluded from the scope of application are techniques involving human gene therapy, techniques inwhich rDNA molecules or genetically modified organisms are not employed.
Under section 5(a) any applicant requiring to develop, produce, use or apply genetically modified
organisms “or to release such organisms into the environment, to submit to the Council through theregistrar, an assessment of the risk and, where required, an assessment of the impact on theenvironment of such development, production, use, application or release …” Section 5(k) gives
authority to the Executive Council of Genetically Modified Organisms to “promote co-operation
between the Republic and any other country with regard to research, development and technology
transfer in the field of the genetic modification of organisms.” This provision is largely a reflection of
the country’s aspiration to continue to invest in modern biotechnology with emphasis on thedevelopment of and trade in genetically modified organisms.
South Africa’s biosafety law contains other provisions covering such areas as determination of risks
and liability (section 17 para 2) and confidentiality and disclosure of information on risks and natureof genetically modified organism(s) (section 18). The law as whole should be carefully reviewed toestablish the extent to which its provisions are in conformity with the Cartagena Protocol on Biosafety
to the Convention on Biological Diversity.

7

Act 15 of 1997
Section 14(2)(1), which is subject to the provisions of sub-section (2)9Section 6(1)10Section 6(2)8

10ATPS SPECIAL PAPER SERIES N O. 15

Egypt has invested considerably in genetic engineering of potatoes, cotton, maize and tomatoes.
The country has at least 3000 scientists active in biotechnology-related fields and more than US$
100 million annually allocated to biotechnology R&D projects. It is focused on genetic engineering
for crop improvement. The Agricultural Genetic Engineering Research Institute (AGERI) has
conducted genetic transformation of cotton, cucurbits, maize, potato, and tomato. With funding fromthe United States Agency for International Development (USAID) it undertook genome mapping of
tomato and rapeseed. The Centre for Genetic Engineering and Tissue Culture at Menoufiya University
has transferred Bacillus thuringensis (Bt) toxin genes into cotton. Similar R&D are being conductedby Cairo University’s Centre for Genetic Engineering at the Faculty of Agriculture where Bt genes
have been inserted into Egyptian clover.
Between 1994 and 1998 trials of GMO maize, cotton, potatoe, tomato and squash were conductedunder greenhouse containment at the AGERI. During the same period field trials of GMO squash
resistant to Zucchini Yellow Mosaic Virus (ZYMV), GMO potato resistant to potato tuber moth virus
and GMO tomato resistant to tomato yellow leaf curl virus were conducted by the AGERI. Recently
the Government of Egypt and Monsanto entered into agreement to field test and to subsequently
commercialize cotton with Bollard Bt gene. The country has also imported genetically modified
pharmaceutical products. These products include Actrapid 40 U HM/ml (human insulin) producedby Novo Nordisk, Roferon-A (Interferon alfa-21) produced by La Roche and Pronivel 2000 LU(Recombinant human erythropoietin) by Laboratorio Elea Argentina.
In 1995 Egypt instituted biosafety regulations. Two decrees, Ministerial Decree No. 85 of January 25,
1995 and Ministerial Decree No. 136 of February 7, 1995 establish both procedures and institutionalarrangements for regulating the development and application of modern biotechnology and its
products, and more specifically for approving field testing of GMOs. Procedures for commercializing
GMO crops were instituted in 1998 by Ministerial Decree No. 1648. Between 1996 and 2000, 34
GMO field trials were conducted in the country.
Kenya’s biotechnology R&D efforts have concentrated on the application of tissue culture to improve
the production of food crops. For example, the Kenya Agricultural Research Institute (KARI) is
collaborating with the Institute for Tropical and Sub-Tropical Crops (ITSC) based in South Africa tomicro-propagate or develop pathogen-free banana planting material. This involves rapid and sterile
multiplication of banana plantlets by in vitro propagation. In 1991 KARI in partnership with MonsantoInc. launched a project on the application of genetic engineering to develop sweet potato resistant
to Feathery Mottle virus. Monsanto developed a protein responsible for virus resistance and donatedit to KARI for use royalty free. There are also efforts at KARI with support of the Norvatis Foundation
and CYMMIT to develop Bt maize.

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

11

In 1998 Kenya adopted regulations and guidelines for biosafety. These, the Regulations andGuidelines for Biosafety in Biotechnology for Kenya11, explicitly recognize the role that biotechnology
can play in the economic transformation of the country. They lay down procedures for field andcontained testing of genetically modified organisms. A National Biosafety Committee (NBC)administered by the National Council for Science and Technology was established to implement
the regulations and guidelines. It is the authority responsible for granting approvals for GMO testing,import and export. The Committee has approved field- testing of the Bt maize and the GMO sweet
potato.
Zimbabwe’s Central Veterinary Laboratory (CVL) is involved in the production of both attenuated andrecombinant DNA vaccines. It is also involved in the diagnosis and culture of both animal and poultry
pathogens. The CVL uses recombinant Escherichia coli to express proteins from genes of interest.
It has some of the capability for genomics and proteomics.
In 2000 Zimbabwe enacted biosafety regulations. The Research (Biosafety) Regulations, Statutory
Instrument 20 of 2000, regulate the development and application of modern biotechnology in general,and genetically modified organisms in particular. Section 3 of the law defines the scope of application.
It stipulates that the “regulations shall apply to:(i) techniques in which recombinant DNA molecules or genetically modified organisms are
employed in in vitro fertilization in human beings and animals; or conjunction, …transformationor any other natural process; or polyploid induction;(ii) techniques in which genetically modified organisms as recipient or parental organisms are
employed in mutagenesis; or the construction and use of somatic hybridoma cells; or …any
activities involving genetically modified organisms that are declared by the Council in terms of…to constitute potentially harmful research or undertakings.”
Zimbabwe’s biosafety law places a lot of emphasis on institutional or agency aspects. The law, as
we shall show below, creates institutional arrangements for managing biosafety at national andindividual agency levels. Its coverage of such issues as risk assessment procedures, application of
the precautionary principle, liability and redress, convergence with national and international tradelaws, and information exchange is fairly general. The law requires the National Biosafety Board(established by section 4) to formulate detailed biosafety guidelines and standards as well as a longterm policy for safety in biotechnology. It is largely a technology management instrument and placesemphasis on the promotion of biotechnology R&D.
Cameroon has also invested in the development of national biosafety legislation. With financial
support from the Global Environment Facility (GEF) through UNEP the country by January 1999 had
11

Republic of Kenya 1998. Regulations and Guidelines for Biosafety in Biotechnology for Kenya. National Council for Science andTechnology (NCST), Nairobi.

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ATPS SPECIAL PAPER SERIES N O. 15

a draft bill on safety in biotechnology. The draft bill, prepared under the leadership of the Ministry of
the Environment and Forestry, has three objectives to:(i) provide a framework and guidelines for the safe, ethical and responsible research anddevelopment in modern biotechnology;(ii) provide a framework for assessing, managing or controlling the risks associated with the use,release and transboundary movement of living modified organisms or organisms with novel
traits resulting from modern biotechnology which are likely to have an adverse environmental
impact that could affect the conservation and sustainable use of biological diversity, taking into
account the risks to human and animal health, their socio-economic impacts, while maximizing
the advantages of the technology; and(iii) create a National Biosafety Authority charged with the overall supervision of the implementationof this law and regulations in collaboration with existing competent administrations.”
Article 2 of Cameroon’s draft bill defines scope of its application. It excludes organisms developedwith the aid of cell technology, modified plants obtained by means of
2.2 Biotechnology R&D in Asia: Some Examples
Many of the Asian countries are investing in biotechnology R&D and some have already put GMO
products on the market. China is one of the Asian leaders in biotechnology. The country has dedicatedits economic, scientific and technological resources to R&D in such areas as the development ofpest resistant GMO cotton, recombinant drugs, and gene therapy of malignant tumors. The Chinese
Academy of Science (CAS) Molecular Biotechnology Research Laboratory is the main body dedicatedto R&D in plant genetic engineering. By mid 1998 GMO tomato, sweet pepper and petunia developedby Chinese universities had been approved for commercialization while several other GMO crops
were being field tested in the country. Monsanto has commercialized Bt cotton in China. In 1999, 26
applications for commercializing GMO crops (multiple varieties of cotton, tomato, rice, green pepper
and petunia) were approved.12 By 2000 China was the second largest producer and exporter of Bt
maize, accounting for 21% of the total acreage.13
There are more than 200 companies most involved in commercial biotechnology activities in China.
Thirty companies have obtained the required approvals to manufacture 12 kinds of human therapeutic
biotechnology products. Some of the multinational companies either operating in China or exporting
products to China include Pasteur Merieux Connaught, Sanofi Biological Serums and Vaccins,
SmithKline Beecham Biologicals, Merck Sharp and Dhome, Upjohn Schering-Plough, Baxter, Amgen,

12

Paarlberg, R. 2000. Governing the GM Crop Revolution: Policy Choices for Developing Countries. International Food Policy
Research Institute.
13
Carpenter, J. and Gianessi, L. 2001. Agricultural Biotechnology: Updated Benefit Estimates. National Centre for Food andAgricultural Policy, Washington, D.C.

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I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

Kirin and Novo Nordisk in the field of medical biotechnology and Monsanto, and Delta and Pine
Land in the field of plant biotechnology. Some of the domestic companies involved in medical
biotechnology production/marketing activities are China Pharmaceutical Company, China National
Bio-product Company and China Medical and Equipment Company.
Table 2: Applications approved for field-testing or commercialisation of transgenic plants
PlantsRice

Field Trials
6

Commercialization
1

Maize

2

—

Soybean2—

Cotton72

Tobacco4—

Potato6—

Tomato3

1

Green Pepper

1—

Chili Pepper

1—Tropical fruit

1—

Flower—1

Poplar tree

1

—

Total
34
5
Source: Carl E. Pary, 1999. ‘Public and Private Collaboration on Plant Biotechnology in China’, Agbioforum,
January, 1999

China developed and adopted the safety administration regulation on genetic engineering in 1993.
This instrument aims at promoting biotechnology R&D while ensuring that products of genetic
engineering are safe to human life and the environment. The State Science and Technology
Commission (SSTC) of China is responsible for promoting the implementation of the regulations. In
1996 the Ministry of Agriculture issued the safety administration implementation regulation on
agricultural biological genetic engineering. This is an explicit regulatory regime for risk assessmentand management of agricultural products of genetic engineering.
All medical biotechnology products, including pharmaceuticals, imported into or manufactured in
China are regulated by the Drug Administration Bureau (DAB) under the Ministry of Health. Based onlaboratory reports prepared by the National Institute for the Control of Pharmaceutical and Biological
Products (NICPBP), the DAB’s bioproducts division recommends approval or rejection of license
applications. DAB also controls authorization procedures for clinical trials of pharmaceuticals.
India is also devoting a growing portion of its R&D budget to biotechnology. Specific areas of investment
include the development of insect resistant transgenic rice plant, development of transgenic brassica

14

ATPS SPECIAL PAPER SERIES N O. 15

for fungal resistance, development of transgenic plants of chickpea, and use of anti senra RNA todelay fruit ripening. The first GMO testing in India was done in 1994-95, when Brassica juncea plantcontaining the barnase genes were planted at Gurgaon near Delhi to assess the extent of pollen
escape. Since then several GMO field and contained trials have been conducted. Monsanto has
conducted Bt cotton trials in India. It has, also is conducting bollgard Bt trials, Proagro PGS is testingmustard.Trials of GMO potato, cauliflower, rice, and tobacco have also done.
Monsanto has formed a joint venture with Indian Company Mahyco to create Mahyco-Monsanto
Biotech Private Limited (MMB). MMB is actively engaged in developing Bollgard insect resistantcotton in Indian hybrids. Monsanto has invested about $100 million in India in agrochemicals andother industrial activities.
India has established biotechnology and GMO regulatory measures. In 1994 the Department of
Biotechnology, revised its earlier guidelines of 1990 titled “Revised Guidelines for Safety in
Biotechnology”. The revised guidelines aimed at regulating large-scale production and deliberate
release of GMOs, plants, animals and products into the environment, shipment and importation of
GMOs for laboratory research.
Korea has a dynamic and growing biotechnology industry. The importance of this industry is manifested
in the size of its total financial contributions to biotechnology R&D and its products sales. Private
biotechnology industry’s investment in biotechnology grew at an average annual rate of 44.5 percent
in the 1980s and early 1990s. During this period the development of vaccines and diagnostics
received at least 60% of the country’s investment in biotechnology R&D. 14 In the later part of the
1990s Korean firms began investing in more agricultural biotechnology. Green cross, Heungnong
seeds, Joongang seeds, and Seoul seeds are among the leading companies in agricultural
biotechnology R&D.
The country has instituted regulatory measures for safe development and application of biotechnology.
In 1997, the Ministry of Health and Welfare promulgated the guidelines for recombinant DNA
experiment covering physical and biological containment for small and large-scale experiments,
proper handling of rDNA molecules including storage and movement of rDNA organisms, safetycontrol measures and safety evaluation procedures. The Ministry of Agriculture is preparing theguidelines for experiment and handling of rDNA organisms in agriculture, forestry and livestock.
Other Asian countries are engaged in the development, importation and export of GMOs. By early
2000 Indonesia had five GMO crops approved for field trials. They are Bt cotton, corn, roundup ready

14

Acharya, R. and Mugabe, J. 1995.

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

15

cotton, roundup ready corn and roundup ready soybean. Thailand has approved several field trails
and commercialization of GMO products. For example, in 1994 it approved application by Calgene
Fresh Company to conduct a field test GMO Flavr Savr tomato. By 1996 Flavr Savr tomato had been
approved for commercialization in Thailand.
Indonesia has commercialized Bt cotton. It has more than 4,000 hectares of this crop grown in theSouth. The government approved contained and field trials of this Bt cotton in 1998 and 1999
respectively. Trails were conducted by the Monsanto in collaboration with Hasanuddin University inSouth Sulawesi and Universitas Gadjah Mada (UGM).
Malaysia has also received and approved GMOs for field trials and commercialization. In October
1996, the Malaysian government received an application for the import of transgenic soybean forfood and feed. This was the first application to be reviewed by the country’s Genetic Manipulation
Advisory Committee (GMAC). The glyphsate-tolerant “Roundup Ready Soybean”, line 40-3-2,
containing enolpyruvateshikimate-3-phosphatesynthase (EPSPS) gene derived from Agrobacteriumsp.
The Philippines has had several applications for field trials and commercialization of GMO crops. In
1999 two multinational companies, Agroseed Corp. and Pioneer Hi-bred Philippines Inc., applied for
permits to conduct field trials of Bt maize with resistance against Asiatic corn borer. The companies
are to conduct these trails in collaboration with the Institute of Plant Breeding (IPB) of the Universityof the Philippines in Los Banos (UPLB). The country has a body of policies aimed at regulating thedevelopment, importation, transfer and use of GMOs. In 1990 an executive order was issued by the
President to establish the National Committee on Biosafety of the Philippines (NCBP). In 1991, the
NCBP and the Department of Science and Technology developed and published national biosafety
guidelines.
2.3 Biotechnology in Latin America
In Latin America, leading actors in biotechnology include Argentina, Brazil and Cuba. Argentina is
one of the major exporters of genetically modified crops. It is estimated that GMO soybean occupies
40% of the land area under soybean cultivation in the country. The number of GMO field trials has
considerably increased over the last few years. Between 1991 and 1994 42 field trials were approved.
In 1995 alone 36 were approved and 78 in 1997 and 90 in 1998. 44% of the field trials carried out in1998 were performed with maize, 27% with sunflower, 13% for soybeans and 5% for cotton,as wellas rice and wheat .
Argentina has instituted regulatory measures for the safe development and application of
biotechnology in general and GMOs in particular. It has policies, procedures and institutionalarrangements to regulate the development, importation and export of GMO products. The country
uses GMO specific legislation and implicit laws covering veterinary products and seeds. There are
explicit regulations on contained use, deliberate release and commercialisation of GMOs. These

16

ATPS SPECIAL PAPER SERIES N O. 15

are contained in Resolutions of the Secretary of Agriculture, Livestock, Fisheries and Food (SAGPyA)
No. 656 of 1992, No. 837 of 1993, and No. 289 of 1997. Additional regulations apply to human safetyof foods and food ingredients containing GMOs. These are deposited in SAGPyA No. 511 of 1998.
The regulations focus on the properties of the new trait and not on the process used to develop aparticular GMO.
The National Biosafety Committee (CONABIA) established in 1991 by the SAGPyA to provide advice
and oversee the implementation of biosafety regulations. It reviews applications for testing andcommercialising GMOs in the country. CONABIA recommends to SAGPyA whether to approve ordisapprove applications. Final decisions are made by SAGPyA. It is the one that also grants permits
for GMO testing and commercialisation.
Cuba has also invested considerably in modern biotechnology. In 1998 the Government of Cuba
allocated a budget of US$ 50-70 million to biotechnology R&D with emphasis on the development of
GMO products. The country’s biotechnology R&D activities are conducted and coordinated by theCentre for Genetic Engineering and Biotechnology (CIGB) and the Centre for Molecular Immunology(CMI). With modern production facilities and highly trained personnel, the CIGB has devoted its
efforts to the development of new products using recombinant DNA techniques. Its products include
the production of hepatitis-B vaccine and a vaccine (on trial) against the HIV. Cuba is also engaged
in the production of GMO crops. The country has enacted legislation to regulate the development,
testing and commercialization as well as import and export of GMOs. Decree No. 190 of 1999 spells
policies and scientific procedures for assessing risks and regulating GMOs
In Brazil, until July 1999, 112 institutions have been awarded permits to work on GMOs research.
The Brazilian government holds a peculiar position distinctive from other Latin American countries,
having set up a legally binding regulatory system for the sustainable development of biotechnology
considering biodiversity issues and the preservation of biological species along with fundamental
biosafety questions. Brazilian biosafety regulation establishes guidelines for the contained use ofgenetic engineering techniques and for field trials with Genetically Modified Organisms (GMOs),
managed by the National Technical Biosafety Committee. Therefore, the Brazilian regulatory
framework is then similar to the European regulatory system, since it considers the control of DNA
technology distinctively from other technological processes.
Based on the Law Project of the then Senator Marco Maciel and after five years of negotiations within
the regulatory instances of the government, in 1995 the Brazilian Biosafety Law was set up and the
National Technical Biosafety Committee (CTNBio) created: Law 8974 /95. The President has madea few sanctions to the law, on the chapter referring to the link of CTNBio to the Presidency. This veto
was explained since the creation of public institutions is of exclusive competence of the Executive
Government and since the law did not include the participation of environmental protection groups,
consumer protection agencies and representatives from the industry and workers’ health.

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

17

Among the main characteristics of Brazilian Biosafety Law 8974/95, it is worth pointing out the maindifferences from other countries’ regulation:•

Emphasises the technique used in the genetic modification, regarding how the organism
has been modified through DNA/RNA recombinant techniques. Note that the regulation in
many countries focuses only the resulting phenotype and/or the environment where fieldtrials will be conducted.

3.

International Public Policy Issues

3.1 Public Perception
Public perception of modern biotechnology is one of the factors that now influence the direction of
innovation in, including commercialization of, the technology. It varies from one country to another,and from one region to another. It is largely influenced by values and psychological factors as well as
public confidence in scientific agencies responsible for risk assessment and management. It is also
influenced by information from industry, governments, scientists, public interest groups, and the
media. Regulatory and scientific agencies are expected to conduct objective risk assessment andto provide the public with factual information on the nature of risks and benefits of a particularbiotechnology product or process.
Most of the assessments or studies of public perception of biotechnology have been conductedin developed countries. However, efforts are now being made to assess public attitudes to thetechnology in such countries as the Philippines and Mexico15. These studies show that although thelevel of developing countries’ public awareness of and concern about GMO are lower than in thedeveloped countries, they are not nonexistent. The current debate on the impacts of geneticallymodified organisms tends to assume that developing countries’ publics are not aware of andconcerned about biotechnology—its positive and negative impacts. In a recent paper Aerni argues
that:
The transatlantic debate is strongly dominated by Western perceptions about the risks and benefits of thistechnology and how developing countries should solve their agricultural problems. Very often, stakeholders inpublic debates in Western countries are NGO leaders or academic professors from developing countries who
fit their view or interests and invite them to speak for the developing countries as a whole. But, apart from the factthat these experts cannot represent the view of their own country, … There is not just a single developing country
perspective but several, each reflecting the particular social, political, economic and cultural circumstances.16

15

See Aerni, P. 2001. Public Attitudes Towards Agricultural Biotechnology in Developing Countries: A Comparison between
Mexico and the Philippines. Science, Technology and Innovation Discussion Paper No. 10. Cambridge, MA, USA: Centre forInternational Development.
16
See Aerni, P. 2001. Public Attitudes Towards Agricultural Biotechnology in Developing Countries: A Comparison between
Mexico and the Philippines, p. 10. Science, Technology and Innovation Discussion Paper No. 10. Cambridge, MA, USA: Centre
for International Development.

18

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

19

Recent media attention in Europe has increased public debate and controversy over the safety ofGM crops and foods generally. In the UK the debate may have been aggravated by the bovine
spongiform encephalopathy (BSE) and traces of Escherichia coli found in meat products. The BSE
crisis undermined public confidence in UK’s institutions responsible for regulating safety of foods. In
Europe there is growing public hostility to GMO products.
Genetically modified foods challenge traditional European ideas about food. Europeans simply regard biotechnology
with suspicion, at least where their food is concerned. …All the talk of Frankenfoods in the United Kingdom has
left its mark. Because of the public’s response, the European approval procedures for GMOs are stringent andthorough. …European resistance to the introduction of GMOs is so strong that approval has practically come toa stop. Europe is faced with a crisis, voters do not want GMOs and do not believe in assurances of their safety.
As a result, Europe is in danger of rejecting this new science of biotechnology despite its enormous potential forgood. 17

The European anti-biotechnology stance may influence some of the developing countries’ policies.
It is likely to have irreversible consequences for the entire field of biotechnology and its potential
benefits for the poor in developing countries.
The participation of developing countries in the ongoing debate on biotechnology should be
influenced and informed by their own aspirations, needs and perceptions of this technology. It should
evolve as these countries gain a better understanding of the technology, and as their R&D efforts
generate new products and processes, and as they experiment with biosafety regulations to assess
and manage risks. What is of concern is that the growing uncertainty and anxiety over GMO productsin Europe may undermine their current investments in R&D. Again the challenge is one of building
regulatory measures and capability that promote investment in the technology while ensuring thatscience-based risk assessment form the basis for decision-making.
3.2 Regulatory Approaches and Capability
The above review of the status of biotechnology demonstrates that there is a correlation between
investment in R&D and the formulation and implementation of regulatory measures for biosafety.
Countries that have more established biotechnology R&D programmes and are either
commercializing and/or testing GMOs also possess relatively developed biosafety instruments. The
review also shows that countries have either formulated single explicit or use several regulatory
instruments. Many of the developing countries involved in biotechnology R&D have adopted explicit
biosafety regulations and established specific agencies or committees on biosafety.

17

Richardson, J. 2000. ‘EU Agricultural Policies and Implications for Agrobiotechnology ’, p. 81 in AgBioForum, Volume 3, Number
2&3, 2000.

20

ATPS SPECIAL PAPER SERIES N O. 15

There are marked differences in developed countries’ regulatory approaches. In 1986 the US adopted
the “Coordinated Framework for the Regulation of Products of Biotechnology” that created a strong
federal commitment to the safe development of the products of biotechnology from the laboratory,
through field-testing and development, and to commercialization. This framework is founded on theprinciple of substantial equivalence—that any risks from biotechnology products are the same inkind to those of similar products. USA regulatory agencies are the Environmental Protection Agency(EPA), the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services,and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture.
APHIS regulates the development and field-testing of GMO plants and microorganisms. It reviews
environmental and agricultural safety of the GMOs. The FDA is responsible for assessing food safety
and nutritional aspects of new plant varieties. It requires that GMO foods meet the same standards
as is required of all other foods. EPA handles safety of pesticides and establishes tolerance standards
or levels for substances used as pesticides in food and feed. It is also responsible for issuing permits
for field testing of GMO plants with pesticidal traits.
The European Union’s (EU’s) main instrument for regulating the development, testing andcommercialization of GMOs has evolved since the early 1990s. The Directive 90/220/EEC on the
deliberate release of genetically modified organisms requires an assessment of environmental
impact and promotes a step-by-step approach in granting approvals for release of GMOs. It requires
an importer or manufacturer to submit a notification to the national component authority of a Member
State where the GMO is to be first placed on the market before releasing it into the environment. The
notification must contain information on product, and dossier of all risk assessment conducted on
the product. EU’s risk assessment approach takes into account how the product was developed,
including the processes of generating a GMO product. Austria, France and Germany have invoked
Article 16 (safety clause) of the Directive 90/220/EEC to temporarily ban the commercialization of
GMO corn and oilseed in their economies.
The US and EU regulatory approaches differ in two ways. First, while the US focuses on regulating
the end product, the EU tends to regulate the whole process of biotechnology R&D andcommercialization of products. Secondly, “US policies tend to be more supply-driven, while EU
policies are demand-driven, dominated by consumer concerns. Thus, efficiency of production is thepresiding goal in the US. In the EU, on the other hand, emphasis is on quality aspects, both of
products and of production methods”.18
Many of the developing countries are instituting biosafety frameworks [several of them with financial
support from the Global Environment Facility (GEF)] with procedures and institutional arrangements

18

Haniotis, T. 2000. ‘Regulating Agri-Food Production in the US and the EU’, p. 84 in AgBioForum Volume 3, Number 2&3, 2000.

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

21

for regulating the development, testing and commercialization, including importation of GMOs.
While the developed world (particularly in the US) regulatory measures are now mainly for purposesof promoting knowledge-intensive biotechnology industry to expand national competitiveness in the
global economy and ensure environmental safety, biosafety frameworks of many developing countries
are not being introduced with the goal of promoting industry but mainly for risk assessment andenvironmental management. In terms of the explicit goals of their regulatory regimes, developing
countries can be categorized into three groups. The first is a group of countries that aspire to develop
domestic biotechnology through national public R&D and/or by creating incentives for the participationof multinationals as sources of technology. These countries have relatively liberal regulations. They
also have more explicit regulatory institutional arrangements. They include Argentina, Brazil, Cuba,
Egypt, South Africa, India and Zimbabwe.
A second group of countries is that which has adopted more defensive measures to assess andregulate the development, testing and commercialization of biotechnology. “Generally, in thesecountries norms in any form (voluntary or mandatory) are accompanied by regulatory inertia due tothe competing jurisdictions of the authorities involved, pressure from interest groups, or inability totake informed decisions. Regulatory oversight in terms of monitoring or enforcement is absent inmost cases”,19 Ethiopia is an example of this group.
The third group is that of countries where there is no domestic high level biotechnology R&D and noestablished commercialization of GMOs by external agencies, and with no explicit regulatory
measures. In this group are a large number of African countries, for example Burundi, Sudan, andTanzania.
The first category of countries is likely to attract private investment and activity in GMO development,
testing and commercialization. It will also witness rising rates of technology transfer as such companies
as Monsanto establish local presence start socializing with local public R&D actors. These countries’
capability for and public confidence in GMO regulation may grow as they engage in intense
biotechnology R&D and an incremental further revision and development of their regulatory systems.
On the whole, there are many developing countries with regulatory systems. Their approaches varyand capabilities differ. However, many of these countries are faced with challenges of strengthening
their regulatory systems to respond to domestic and international demands. In general terms, they
suffer from inadequate financial and human resources and young (and in many cases absence of or
existing of weak agencies) regulatory institutional arrangements. It is this context that developing
countries must make decisions on GMOs and move into implementing the Cartagena Protocol on
biosafety to the convention on biological diversity.
19 Tzotzos, G. 1999. ‘Regulation of Biotechnology in LDCs’, p. 214 in AgBioForum Volume 2, Number 3&4, 1999.

4.

The Way Forward For Africa

How then should African countries respond to the opportunities and challenges posed by genetic
engineering? We suggest that these countries should establish broad-based platforms to mobilize
the public and scientific communities to build confidence in the technological advances associatedwith genetic engineering. In addition, they will need to identify their specific national priorities in foodproduction and harness the growing body of science and innovations in genetic engineering toaddress specific problems. Public R&D agencies and policies dedicated to genetic engineering aswell as partnerships with private industry will be crucial, and lastly African countries will need develop
and implement regulatory measures to manage any environmental, economic, health and social
risks associated with genetic engineering. Below we expound on each of the actions.
4.1. Build Public Confidence and Participation
Science in general and genetic engineering in particular are not evolving in a socio-political vacuum.
The African public and politicians have (or should have) a direct interest in scientific advances andtechnological developments associated with genetic engineering, yet they are not participating in
the GM debate. In many countries of the region there are obstacles to citizens’ participation in thedebate on the impacts of GM crops and the potential role of genetic engineering in solving foodinsecurity. Considerable institutional space in the debate has been taken by isolated groups of nongovernmental organizations opposed to GM crops and purporting to speak for the African rural poor,and groups of scientists who espouse the benefits of the new technology for the poor. It is unlikely thatthe two groups—anti and pro GM crops groups have the attention of millions of farmers in Africa. The
general public and farmers in particular are not informed about the nature of the technology, its
potential benefits and risks, and rarely do they participate in deciding on what crops or problems
biotechnology research and development should focus on.
With the intensifying debate on GM crops, confusing counter claims from pro- and anti-GM activists,and often passive reactions by African governments, the public is likely to lose confidence in thescientific enterprise and overall decision-making authorities. What are required in the region today
are processes that will legitimately bring the voices of the public to inform and change the focus andcontent of the current debate. Three actions that should be taken to build public participation andconfidence are:22

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY23(a) Well-structured and objective assessment of African public perceptions of and/or opinions
on genetic engineering and GM products should be undertaken. Such assessments
must be accompanied by organized activities to provide the public with reliable andadequate information on the nature of the technology and its products.
(b) Have public stakeholders; the youth, women, farmers and other social groups, legitimately
represented on bodies that are charged with regulating GM import, development andcommercialization. Currently, it is difficult to determine the legitimate loci of GM decisionmaking in many countries of sub-Saharan Africa. Even where biosafety frameworks havebeen developed and adopted (e.g. Kenya and Zimbabwe), political institutions have
either ignored these and have often made policy pronouncements that are not necessarilyfounded on science and informed by public opinion. What is required is the review anddetermination of appropriate decision-making mechanisms. Such mechanisms shouldhave representation from all stakeholders including farmers, consumers,
environmentalists and religious bodies.
If genetic engineering is to improve food production in Africa it is should be guided to co-evolve withlocal social and economic production systems. Appropriate social and economic institutions will be
required to articulate demand for the technology and to act as ‘watchdogs’ for its responsible
application. It is in this regard that we are proposing the establishment of broad-based platforms thatenlarge public confidence in genetic engineering through open participation in priority setting anddecision-making.
4.2. Build and Utilize Public R&D Capacity
To harness and benefit from advances in genetic engineering as well as to manage any risks Africancountries need to build a diverse range of human and institutional capacities. They require expertisein such areas as molecular biology, biochemical engineering, plant breeding and bioinformatics.
They also need national agencies or institutes dedicated to the conduct and management of genetic
engineering. Currently many African countries do not have such agencies. Their limited investments
in genetic engineering and biotechnology tend to be in the form of projects scattered across theinstitutional landscape. This is in sharp contrast to the organization of biotechnology and genetic
engineering activities in such countries as Cuba, China, India and the US where special centersdevoted to genetic engineering have been established. It is probably only in Egypt, Nigeria and South
Africa where agencies dedicated to biotechnology are found.
It is crucial that each African country identifies and implements measures to build dedicatedbiotechnology agencies. Such efforts may focus on identifying a few national institutes with potential,
and providing political support and financial resources to such institutes to grow into national centersof excellence in genetic engineering for food production. These centers should focus on specificpriority problems identified through public participation. They need significant and predictable funding
and should have explicit links to private sector. In addition to research, they should devote theirattention to training of scientists in such new science fields as genomics.

24

ATPS SPECIAL PAPER SERIES N O. 15

The establishment of national centers of excellence in genetic engineering needs to go hand inhand with the creation of appropriate mechanisms to finance R&D. Current funding of biotechnology
R&D is still relatively low to enable African countries to effectively engage in genetic engineering. For
example, an assessment by Falconi in 1999 showed that Indonesia’s total expenditure for the 198596 was US$ 18.7 million while Kenya spent about $3.0 million. Nigeria and South Africa are increasing
their financial investment in biotechnology and genetic engineering. Nigeria’s Federal Government
now provides the National Biotechnology Development Agency with an average of US$ 263 million
per year for the next three years as a start-up grant. South Africa’s new biotechnology strategy commits
more than US$ 300 million per year from government to finance a variety of biotechnology initiatives.
Other countries of the region need to invest more in genetic engineering. Some of them may wish to
create special funding mechanisms, possibly National Biotechnology Funds (NBFs) for R&D. Suchmechanisms would mobilize domestic and international public and private finance to support specificpriority research and innovation activities that target the improvement of food production.
4.3. Establish and Apply Regulatory Instruments
Many African countries lack coherent regulatory instruments and institutions for risk management inrelation to genetic engineering. Where instruments have been formulated and adopted bygovernments, there are weak institutional arrangements for enforcement of regulatory procedures.
As a result, there is no consensus on how best to respond to global developments in genetic
engineering and, particularly, whether to allow the importation and/or development of GM crops.
The current controversy over GM food aid to Zambia and Zimbabwe clearly demonstrates theimportance of governments instituting and applying regulatory instruments as well as risk assessmentand management procedures.
In June 2002 the government of Zimbabwe rejected a consignment of 17,500 tonnes of maize fromthe US because it was not certified free of genetically modified material. The government wasconcerned that some of the grains would be planted and thus releasing GM into the environment
and potentially undermining the country’s exports to the European Union and other countries thathave banned GM foods.20 Zambia also rejected GM maize from the USA citing potential humanhealth risks. This is despite assurance from the US administration that the maize had been tested
and proven to be safe.
There are many interest groups engaged in the debate on whether African countries should accept
GM food. These range of groups of scientists to activists. What is of concern is that they have focusedno or very little attention on how best to use existing national, regional and international regulatory
instruments to make informed decisions. In some cases some may be exploiting such situations as

20

Zimbabwe’s government recently accepted the GM maize after protracted controversy and diplomatic interventions from the
USA and the World Food Programme.

I NTERNATIONAL T RENDS IN M ODERN BIOTECHNOLOGY

25

political uncertainty and economic instability to promote narrow agendas to deny the public choice
and to undermine national learning from the application of risk assessment and management
instruments. In Zimbabwe for example the debate acquired an intense political tone and locus ofdecision-making become full of intense diplomatic interventions denying local scientists and national
regulatory authority space to engage in risk assessment. Our survey and consultations with relevant
government officials and scientists show that the government did not in a procedural way apply
provisions of national biosafety regulations. The Research (Biosafety) Regulations Statutory Instrument
20 of 2000, regulates the development and application of modern biotechnology in general, andgenetically modified organisms in particular. The law vests responsibility for risk assessment with
the National Biosafety Board (established by section 4).This Board did not get an opportunity to
conduct scientific analysis of the GM maize offered by the US.
Risk management and making decisions on the development, importation and use of GM crops areknowledge intensive responsibilities that require the participation of scientists and consumers.
Appropriate regulatory instruments should guide these processes. Such instruments should enablecountries to invoke the precautionary principle without denying them with opportunities to address
short-term and urgent needs, particularly in terms of access to and provision of food to the hungry.
They should create institutional arrangements that mobilize domestic and international science tomake informed decisions.
There is need to build national capacity to assess and respond to risks as well as to tap benefits
generated by genetic engineering. Such initiatives as the capacity building programme of theInternational Center for Genetic Engineering and Biotechnology (ICGEB) will play a major role inbuilding the capacity of African countries to conduct risk assessment. The ICGEB is engaged in thebuilding of national capacity in industrial, agricultural, pharmaceutical, animal and human healthbiotechnology. The ICGEB has now more than 30 affiliated centers around the world some of whichhave emerged into centers of excellence in genetic engineering.
4.4. Build Public-Private R&D Partnerships
A large and growing portion of the scientific information and investments in genetic engineering areheld by private sector mainly in the industrialized world. According to Ernst & Young, for example, in1997 US companies invested $9.4 billion in R&D, employed 140,000 people and posted total revenues
of $18 billion. At the same time there were 1,036 European companies working in the life sciences,
employing more than 39,000 people directly, with revenues of $3.1 billion and $2.2 billion invested in
R&D.21 For public research institutions in Africa to access this information they will need to create
strategic links with or to the private companies in the industrialized countries. The second reason

21

See Falconi, C. 1999 for Ernest and Young data.

26

ATPS SPECIAL PAPER SERIES N O. 15

has to do with the fact that commercialization of biotechnology is effectively achieved with theparticipation of private sector. The economic history of public R&D in many parts of the world
demonstrates that public agencies have limited capacity to engage in the commercialization of new
innovations. They often require private entrepreneurs to take their innovations into the economic
domain.
Another good reason is that private biotechnology companies are potential new sources of financial
resources for biotechnology R&D in Africa. The historical evolution of biotechnology in such countries
as the US, Germany and Japan vividly demonstrates, the role of companies as sources of finance forbiotechnology R&D. In Japan biotechnology companies have financed biotechnology R&D throughsuch arrangements as venture capital. In the US they have provided finances to university departments
and scientists to undertake specific research on contract basis. Countries of Africa may wish to
explore and exploit financial opportunities associated with partnering with private companies.

5.

Conclusion

This paper has given a general sense of trends in biotechnology development and commercializationand drawn out some of the policy implications for developing countries. It has shown that a growing
number of developing countries are already investing in related R&D, and some are exporters ofgenetically modified products. Their success in acquiring and sustaining global markets for theirbiotechnology is dependent on public perceptions of the technology, its risks and the nature andlevel of public confidence in national regulatory regimes. Countries of Africa should eschew theeither or, pro and anti- sentiments and erect scientific and technological foundations for harnessing
benefits of the new science while at the same time reducing risks. It is through their own investment
in genetic engineering that they are able to make informed decisions on which specific GM crops toimport or accept as part of any food aid. Furthermore, with increased investment in genetic
engineering that targets specific food production challenges, it may be possible to build the basis forfood security in the region: reducing dependency on food aid. Africa requires genetic engineering aspart and parcel of its endogenous scientific and technological development.

27

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