Annotated Bibliography Entry
Reference:
ISNAR 2002b
Title: Next Harvest: Advancing Biotechnology’s
Public Good.
Authors: Luijben, M. and Cohen, J.I.
Publisher: International Service for National Agricultural Research
(ISNAR), The Netherlands
Publication details: Report of a Conference, 7-9 October 2002, ISNAR,
The Hague, The Netherlands
Summary
Scope
of Research
Table
1: Next Harvest, most researched food crops by region
Annex:
Biotech in Practice
in the Developing World
Table of Contents
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Summary
Developing
countries are advancing efforts to use biotechnology to improve food
and fiber crops for the benefit of their populations. Publicly funded
agricultural research programs in Africa, Asia, and Latin America are
combining new biotechnology techniques with indigenous genetic diversity
and local varieties, mainly to develop insect, virus, and herbicide
resistant crops and improved fruits and vegetables.
More than 40 crops are being targeted for improvement using biotechnology.
While
intellectual property issues have thus far proven manageable for most
countries, high regulatory costs, increased public concerns, and lack
of knowledge regarding the potential benefits and risks of biotechnology
confine research products to the laboratory. The research institutes
are anxious, however, to get new products to the farmer and establish
evidence of biotechnology's potential impact on food security among
developing countries.
These
are some of the findings from a meeting, titled Next Harvest: Advancing
Biotechnology's Public Good, and held on October 7-9, 2002 in The
Hague, the Netherlands. At that meeting, organized by the Biotechnology
Service of the International Service for National Agricultural Research
(ISNAR), research leaders and regulatory community members from 14 countries
took stock of progress made in using biotechnology to enhance agricultural
performance. Each participant brought to the meeting specific details
of food and fiber crop biotechnology undertaken in his or her country,
using a systematic data collection format.
This
approach supplied detailed scientific data on the crops involved, genes
of interest, germplasm sources, traits, regulatory status, and deployment
plans to facilitate national, regional and global analysis. In so doing,
this meeting provided the first collection and verification of information
on public research applications of GM technologies for crop improvement.
Collecting and analyzing comparable data facilitated participants sharing
experiences on virtually every aspect of their biotechnology research.
Analysis of the data collected, verified, and updated at the meeting,
reveals distinct trends in the past and future direction of public biotechnology
research in the developing world.
The
extent of biotechnology research being done by the developing countries
attests to the conviction among scientists and agricultural leaders
that GM crops have the potential to benefit farmers, producers, and
consumers. Significant biotechnology R&D capacity is especially
evident in Asia and Latin America. In Africa, greater challenges were
found, in the limited numbers of trained scientific staff and too few
properly fitted laboratories. However, as evidenced in most countries
studied, the creativity of scientists and these countries' inherent
wealth in genetic resources, are now poised to improve food security
and nutrition by providing new opportunities for developing-country
farmers.
Developing
countries are primarily relying on indigenous biotechnology capacity
in order to develop locally relevant and acceptable products. Indeed,
most of the biotechnology research done so far in the industrial countries
aims at improving temperate crops for farmers who can pay the often
high costs of technologies. The meeting in The Hague went beyond private-sector
commercial efforts. It focused specifically on GM crop research conducted
by and for the developing world, in public-sector agricultural research
institutions that are successfully combining new technologies with a
foundation of local plant breeding and germplasm development.
The
meeting's name Next Harvest signified its concern with
the plight of farmers outside the world's industrial and economic powers.
Public-sector research institutes have a key role to fulfill in developing
and disseminating GM crops for the poor. Without this capacity, one
research option is lost in the hopes of providing a bountiful next harvest
in the developing world; meaning that there will be fewer alternatives
to commercial inputs being developed by private companies.
The public sector's comparative advantage in biotechnology lies
in its ability to design needs-driven projects, rather than the profit-driven
efforts of private companies. Public-sector research focuses on local
priorities, using local germplasm and public goods.
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Scope
of research
In
the 15 countries sampled, more than 40 crops are the focus of public-sector
biotechnology research. The top-10 researched crops are rice (21% of
all projects), potatoes (11%), maize (11%), papaya (8%), soybean (7%),
sugarcane (5%), cotton (5%), tomato (3%), banana and plantain (3%),
and alfalfa (2%). A wide range of other crops together comprises 24%
of projects identified.
In
Asia, rice and papaya are the most common biotechnology research subjects.
Potatoes and maize are most common among African programs; and in Latin
America, potatoes, maize, soybean, and sugarcane are most common (see
Table 1). A host of other food and fiber crops are targeted to a lesser
degree. These range from groundnut, oil palm, and rubber tree to local
varieties of vegetables and fruits.
Virus
and insect resistance are the traits most often targeted by the developing-country
programs, accounting for 31% and 29% of the projects, respectively.
Improving product quality accounted for 9% of projects. Research targeting
fungal resistance, herbicide tolerance, and agronomic properties, accounted
for 7%, 6%, and 6% of the projects, respectively (see pie chart next
page). Other traits account for the remaining 11%.
The
greatest percentage of genes being used are 'off the shelf', meaning
genes or genetic elements that are already available in commercial products,
or that are the property of public research institutes and universities.
This is in contrast to the need for novel, locally isolated genes, some
already being developed by public-sector institutes. When asked which
genes and genetic elements are most valuable, the responses from the
group varied. Participants deemed the Bt gene family (for insect resistance)
and genes for fungal resistance as most useful. Further, a unique gene
for aluminum tolerance (developed in Mexico), a tissue-specific promoter
for rubber (from Malaysia), four corn promoters isolated in Egypt by
AGERI, and new transformation protocols and regeneration systems, also
developed in Egypt, were seen as having high potential. This summary
of the meeting introduces the study to those interested in our future
work, and to potential collaborators. More detailed analysis of this
data and GM applications will be available in subsequent research reports.
Table
1: Next Harvest, most researched food crops by region
Source:
ISNAR 2002b Next Harvest
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ANNEX
Biotech
in Practice in the Developing World
The
wide scope of public-sector work is perhaps surprising for two reasons.
First, biotechnology is often considered the domain of private enterprises
with deep pockets - large multinationals and advanced research institutes
and universities in the industrialized countries with large R&D
budgets. Second, developing-country scientists often work in countries
whose regulatory environment may permit commercial use of fiber crops
(cotton), but take a very cautious approach to the advancement of many
GM staple food crops.
Most
GM crop research in developing country, public sector programs was at
the laboratory, greenhouse, or confined field-trial stage. Few publicly
developed products have reached large-scale field trials and even fewer
have been commercially released to farmers. The lack of clear roadmaps
for getting GM products from the laboratory to farmers' fields was cited
as a major weakness and problem for these programs.
Reasons
why products of agricultural biotechnology seem to be stuck in the laboratory
include a lack of capacity to negotiate licenses to use genes and research
techniques patented by others, especially for crops with export potential,
difficulties encountered in meeting regulatory requirements, and the
lack of effective public commercialization modalities and working extension
networks. A problem facing Africa, in particular, is the lack of a dynamic
private sector to take technologies to the farmer. Nonetheless, the
sheer number of projects in the pipeline and the desire to demonstrate
impact of research is leading many institutes to get more specific about
deployment plans early on.
In
South Africa, for example, the Agricultural Research Council
in collaboration with the Vegetable and Ornamental Plant Institute (VOPI)
has developed a roadmap for commercialization of a GM potato. Negotiations
are ongoing with Syngenta, the owner of the gene used to improve the
potato, and food safety and environmental tests are being done. Similarly,
in Zimbabwe and other African countries, cowpea stakeholders
have formed a group called Network for the Genetic Improvement of Cowpea
for Africa (NGICA). NGICA's aim is to get GM cowpeas out of the laboratory
and into farmers' fields. To this end, it has formulated a step-by-step
action plan and timetable for commercialization of new varieties.
Of
the developing countries, China is most advanced in deploying
GM crops. It has two decades of biotechnology research experience, an
experienced regulatory system, and well developed extension capacity.
This has enabled it to disseminate GM cotton on a large scale, in addition
to approving commercial release of genetically modified tomato and pepper.
More recently, the government of China has adopted a more cautious approach
to the release of GM crops, due to internal political changes and external
trade pressures.
Egypt
also has publicly produced GM cotton that is ready for large-scale trials
and commercial release. The Agricultural Genetic Engineering Research
Institute (AGERI) developed an insect resistant long-staple strain by
crossing Egyptian elite germplasm with Monsanto's Bollgard II, with
the aim of minimizing the use of chemical insecticides and increasing
economic value by improving yield, productivity and fiber quality.
This
Egyptian example indicates the potential for biotechnology initiatives
in the developing world to link with the private sector, at least for
technology transfer and joint research efforts. In this case, AGERI
joined with a private multinational to produce the new variety. However,
will these partnerships continue for seed production and distribution?
Or will local seed companies become involved?
Another
example of public-private collaboration is the development of a GM papaya
by countries collaborating in the Southeast Asia Papaya Biotechnology
Network. Monsanto, the owner of a technology used to produce a new papaya
strain, was one of the private-sector collaborators in the effort.
While countries collaborate scientifically in the papaya network,
the private-sector licenses for using its technologies were negotiated
individually with each country. All rights of use pertain to domestic
use only. If a country decides it wants to produce the GM papaya for
export, it will have to renegotiate the license.
Such
examples of private-public cooperation illuminate ways for advancing
public-sector biotechnology research in the developing world and helping
public institutes cope with growing regulatory costs.
Regulation
Clearly
the extent and purpose of the research summarized above is impressive,
yet the public sector has had only limited success in getting its biotechnology
projects beyond the laboratory and through regulatory requirements.
Meeting these various requirements of regulatory systems can be demanding
and time consuming for many developing country scientists, requiring
additional expertise and experience.
The
Cartagena Protocol for Biosafety, designed to set international standards
for trade in living modified organisms, will also affect the public
research documented in this study. But just how indigenous research
will be affected is as yet unclear, since there is so little knowledge
about public research efforts within the developing countries themselves.
Biotechnology's potential to address local and export crop needs is
also unproven.
Thus, while scientists
are firmly committed to assuring safety as per environmental and health
concerns, it was also recognized that regulatory systems can be 'front
heavy.' That is, institutional and national biosafety committees can
require extensive amounts of data early on. Costly tests may be required
to approve even preliminary glasshouse or contained field trials, with
some countries requesting increasing amounts of data before a permit
is issued. These tough requirements limit the number of trials that
a research institute can conduct. In so doing, they place severe limits
on the variety of phenotypes that scientists need for selection in order
to ensure crop improvement.
While
such testing requirements are proposed as being protective of the natural
environment, many of the test results may be irrelevant to the question
at hand, whether a limited field trial would pose appreciable risks
to the surrounding ecosystem. Excessive testing does have a cost, also
in the form of missed opportunities for research.
As many of the tests are prohibitively expensive for cash-strapped public
research institutions, the question to ask, is "How much additional
safety are we buying with additional investments in biosafety regulations?"
Argentina
has countered this problem by whittling its application procedure for
greenhouse and field trials to a list of 150 questions. Later, for large-scale
plantings or seed multiplication, a comprehensive dossier with study
results must be submitted. At that point, food safety studies and an
assessment of impact on international trade must also be done.
Another
way countries are helping to streamline the regulatory process is by
simplifying their approvals procedures. The Philippines, for example,
issued an executive order in 2002 streamlining its approvals process
by putting the different elements - for example, quarantine and monitoring
- into the same department. South Africa, too, is moving towards this
'one window' approach, which should also make it easier for private
companies to navigate through the system.
Regulatory costing and time to decision
The regulatory costs for the public-sector agricultural research
institutes within developing countries were daunting, representing another
level of planning, budgeting and preparation that must be taken into
account.
In
terms of time, it is difficult to predict how long it will take
to get approval for the commercial release of a GM crop. In Indonesia,
for example, four years were needed for GM cotton to pass the regulatory
bodies to get to the farmer. Almost five years on, GM corn and GM soybean
have yet to get regulatory approval. Regulatory costs in Indonesia are
relatively inexpensive for the private sector but relatively costly
for the public sector, particularly
the costs of generating biosafety and food safety data. Public institutes
are considering collaboration with the private sector as one way to
overcome this problem."
In
India it takes 8-10 years to bring a project from the laboratory to
commercialization. Three to five years are needed for research and five
to eight years for commercialization. The cost of getting regulatory
approvals usually exceeds the research costs.
A
way to reduce the costs of generating food and environmental safety
data is to develop regional 'centers of excellence' where food
safety testing can be done reliably. It is extremely expensive for a
laboratory to become certified for doing food safety tests. If countries
develop complementary testing facilities, they could reduce the costs
of the testing procedures. There already is some regional capacity to
do certain studies, and cooperation could be pursued. The University
of Costa Rica and Embrapa in Brazil, for example, and AGERI in Egypt
all have advanced food safety testing facilities.
ISNAR
and collaborating partners are exploring further research into the costing
of regulation. This will be one of the agreed-on new activities arising
from the meeting.
Gene Flow
Developing-country
biotechnology scientists see themselves not only as users of genetic
wealth, but also as custodians of it, due to the extent of biodiversity
in many developing countries.
For
example, Costa Rica's main source of national income is eco-tourism
and it has the highest biodiversity for a country its size in the world.
For
this reason, gene flow assessments are important when evaluating GM
approvals in Costa Rica. Even though the country is a mere 51,100 square
kilometers, it is home to every wild rice variety that is common to
the Americas, including native oryza species and weedy rice complexes.
To determine where to hold a contained field trial, the university did
an exhaustive biodiversity inventory -- an extremely detailed, national
survey of genotype and location of each of the different rice landraces
and their weedy relatives. Even though cultivated rice is self-pollinating,
which reduces the risk of gene flow, such studies identify areas having
potential for gene exchange among related species, which was found to
include two rice relatives. Building on these findings, and mapping
their locations according to plant growth cycles, a location became
evident where a field test of a GM rice variety could be conducted.
Public Concerns
A
number of factors in the international scene stand in the way of biotechnology
products reaching commercial markets. For example, since 1999 the European
Union has had a moratorium on the import of all genetically modified
products. Before it lifts the ban, it is considering enacting laws that
would require GM foods to be segregated from non-GM products and labeled
as such. Reliably implementing such measures would be near impossible
for countries like Argentina, which export millions of tons of commodities
annually. In effect, Argentina would have to decide to relinquish the
European markets or to stop producing GM crops.
Anti-GM
public sentiment and the lobbying activities of non-governmental organizations
inhibit the advancement of biotechnology everywhere. Thailand's experience
illustrates the potential political clout of anti-GM groups that spread
alarming messages about genetically modified food to the public. Local
NGOs and Greenpeace-Thailand made a pamphlet How to Avoid GM Food and
distributed it on the streets. Public disquiet reached a pinnacle in
1999, when the government banned all GM crops. Currently GM seed is
allowed only for experiments, with few exceptions. The government has
approved GM soybean and corn for commercial use, mainly for animal feed
to help ensure that its livestock and poultry industry does not collapse.
Politicians
have to pay attention to public opinion and scientists have to do their
part in public education. For example, in Thailand, BIOTEC
is developing booklets, brochures, and even cartoons. Attitudes are
different for medicinal uses of biotechnology. The Thai government does
not mind health uses of biotechnology and NGOs have focused on food.
One
suggestion made at the meeting was that the public sector could lead
the way for successful deployment of commercial GM crops by getting
public biotechnology products through the regulatory system and approved
for release. If the first GM crop release was a public-sector product
- perhaps a locally important commodity, like an improved papaya, potato,
or sweet potato - that would engender public confidence and acceptance.
It might also 'kick-start' the regulatory system for further releases
by the private sector. The intention would be to provide concrete evidence
of biotechnology's potential to improve countries' food security.
However,
there was also concurrence that when commercially available, safe and
relevant products are ready for approval, these should not be delayed,
especially as public GM technologies, due to reasons identified above,
may not be ready for many years. When relevant commercial products are
delayed, it is the farmer who loses valuable options. In fact, moving
commercial products through national regulatory systems can be instrumental
in addressing safety concerns while preparing for the use of public
innovations.
Intellectual Property Rights
What
matters most in managing intellectual property rights is understanding
the technology that is being used.
In the
developing countries sampled, overall intellectual property rights issues
seem solvable at present. Abilities depend greatly on the in-country
capacity available, flux in the international legal situation, the type
of technology to be obtained, and if it is to be used for local or export
crop production.
While
many research institutes have managed to negotiate licenses for using
'off the shelf' genes, they are often at an overwhelming disadvantage
vis-à-vis the negotiating skills and legal savvy of the licensing party.
Reaching licensing agreements for newer, cutting-edge technologies also
appears to be far more difficult. Moreover, confidentiality requirements,
also limit opportunities for public-sector institutes to share their
experiences and learn from one another. Capacity to deal with intellectual
property issues must extend
beyond the research institute grounds, to law and judiciary professions
within and across national boundaries.
Brazil's
public-sector laboratories have noticed that the patenting process is
gaining momentum. Scientists are facing increasing "freedom to
operate" constraints, with many genes already patented in their
own country. To assess the situation, Embrapa contracted a lawyer to
do a survey of what patents have been filed and what are expected. Through
this process, Embrapa has realized how crucial it is to assess intellectual
property issues early on, at the research proposal stage.
From Pipeline to Products
The
data and experiences of the Next Harvest participants demonstrate how
far many developing countries have progressed in using biotechnology
while building capacity for regulation. This capacity creates the potential
to bring about a next harvest through public sector research to increase
future agricultural and economic well-being of developing-country populations.
Thus far, the emphasis has clearly been on research and regulatory capacity
building. Now that many GM projects are in the pipeline, there is
a need to advance and deploy the most important and safest products,
and to establish evidence for the role of biotechnology in food security.
But, will this next harvest occur, as many factors work against biotechnology's
ability to serve the poor.
Bringing
these technologies to the farm gate will require that developing countries
bring their biotechnology efforts to a new level. In the Green Revolution,
national research programs adapted techniques and germplasm provided
by international agricultural research institutes. However, in the "Gene
Revolution", the techniques of interest to the developing world
are largely coming from private companies, and the genetic wealth, techniques
and genes developed in their own programs.
There
are three 'pathways to innovation' for future research in developing
countries. The first is the 'gene for rent' model. In this scenario,
a private company would allow anyone to put, for example, its Bt
gene into any crop variety. There is a technology fee, but that is negotiable.
This pathway is IPR sensitive. The companies will only reveal their
latest invention if they know that their intellectual property is safe.
The
second pathway is that of adaptive innovation. Here a developing
country with some biotechnology capacity, would figure out how to exploit
foreign technology for domestic advantage. To follow this route, countries
must be able to experiment enough; and they must have the ability to
terminate the unsuccessful experiments. The regulatory systems also
need to enable the experimentation that will yield success.
The
third pathway most countries take will likely include both imitation
and elements of adaptive innovation. It will be the smallest,
poorest countries, without any capacity, that risk becoming increasingly
isolated, and remain dependent on free technology development and transfer
contributed by the international agricultural research community.
The
extent of biotechnology research being done by the developing countries
reflects a conviction that GM crops can benefit farmers, producers,
and consumers. Therefore, getting this research out of the laboratory
is the current goal of many scientists. One way countries foresee getting
biotechnology products out of the laboratory is through new modalities
for collaboration with the private sector, especially at the final stages
of product development - sharing the costs of environmental and food
safety testing and of releasing technologies to farmers.
Another
means to advance biotechnology is by government's offering incentives
and streamlining regulatory structures. A more active role is required
of the public sector to get new products to farmers.
Finally,
the more advanced research institutes are moving up the ladder, to gene
discovery. South Africa, for example, is ready to advance its capacity
in isolating its own genes.
What's Next
An
action plan, derived from participant recommendations, is being finalized.
Collaborative partnerships are being sought for conducting further
analysis and in-country research and capacity building derived from
the data collected, including crop and technology assessments.
Further details are available from ISNAR’s Biotechnology Service:
j.cohen@cgiar.org, j.komen@cgiar.org.
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ISNAR 2002b. Next Harvest:
Advancing Biotechnology’s Public Good.
Report of a Conference, 7-9 October 2002, ISNAR, The Hague, The
Netherlands
Table
of Contents
Next Harvest
Scope
of research
Biotech
in practice
Food
security
Regulation
Regulatory
costing
Gene
flow
Public
concerns
Intellectual
Property Rights
From
pipeline to products
What's
next
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Web
site: http://www.isnar.cgiar.org/ibs/NextHarvest.htm
