
| Keywords: | Access to genetic resources; Consultative Group on International Agricultural Research (CGIAR); International Plant Genetic Resources Institute (IPGRI); Food and Agricultural Organization (FAO); Intellectual property rights. |
| Correct citation: | Pistorius, R. (1995), "Will Material Transfer Agreements Open Pandora's Box?" Biotechnology and Development Monitor, No. 24, p. 2022. |
Germplasm collections under trusteeship of the Consultative Group on International Agricultural Research (CGIAR) were built up on the basis of the principle of free access to and use of genetic resources. With the implementation of the Convention on Biological Diversity, national states can exercise sovereign rights over genetic resources. The International Plant Genetic Resources Institute (IPGRI) and FAO now attempt to design a mechanism to guarantee a continued access and distribution of germplasm transfers while taking the Convention's prescriptions into account.
Material Transfer Agreements (MTAs) are contracts on the conditions
of transfer and use of genetic resources. They are not a completely new
phenomenon. Especially within the biotechnology industry in the USA, and
lately also in Europe and Japan, MTAs are increasingly being used to transfer
(genetic material of) varieties and/or breeding lines with a potential
commercial significance. MTAs can be considered to comply with growing
market forces on the use of genetic resources. Additionally, since the
current openaccess regime does not result in enough economic incentives
for developing countries to invest in new conservation facilities, the
use of sovereign rights might be considered as a feasible means to generate
addition income.
At the same time, however, MTAs are used to guarantee that genetic
material does not become subject to the private property regime. The Botanical
Gardens at Kew, London, for example, uses MTAs to prevent the contracting
party from using the received material for commercial purposes. As will
become clear in this article, the CGIAR centres intend to use MTAs to ensure
continued free availability of "designated germplasm". Designated
germplasm is germplasm acquired prior to the entry into force of the Convention
on Biological Diversity (CBD), or material developed by a centre from
this germplasm. However, the parameters for the exchange of genetic resources
are changing dramatically, creating a new legal environment for the twelve
CGIAR institutes maintaining germplasm collections. This is particularly
true for the postCBD period, in which the provisions of national sovereignty
in relationship with a fair and equitable sharing of benefits have started
to dominate international decision making.
Changing parameters
The past 10 years show a gradual erosion of the principle that genetic
resources are "heritage of mankind". This principle was first encoded in
the FAO International Undertaking on Plant Genetic Resources established
in 1983. In 1989, the Undertaking was extended by two resolutions. The
first resolution (4/89) recognized that Plant Breeders' Rights, as provided
by the Union for the Protection of New Varieties of Plants (UPOV)
Convention of 1978, were not inconsistent with the Undertaking. It simultaneously
recognized Farmers' Rights, which were defined in the second resolution
(5/89). In 1991, a third resolution (3/91) stated that the concept of the
heritage of mankind is subject to the sovereign rights of nations over
their genetic resources. It also agreed that Farmers' Rights will be implemented
through an International Fund for Plant Genetic Resources.
Not only the FAO Resolutions, but also the CBD has added new conditions
for the access to and compensation for plant genetic resources. The CBD,
which was signed in 1992 and entered into force in December 1993, recognizes
the sovereign rights of nations over their genetic resources, and proposes
the "equitable sharing of benefits from its use."
The effect of the FAO Undertaking and the CBD on CGIAR policies has
been very limited, because (a) the CGIAR genebanks until recently had no
formal ties with the FAO Global System on Plant Genetic Resources for
Food and Agriculture, FAO's institutional structure; and (b) the CBD
did not cover ex situ material already in storage prior to its implementation.
Hence, CGIAR could continue to apply the principle of free access without
having to deal with the question of sovereign rights.
The FAO/CGIAR agreement
Resolution 3 to CBD of the Nairobi Final Act in 1992 identified access
to existing ex situ collections and Farmers' Rights as outstanding
issues to which solutions had to be sought within the FAO Global System.
On 26 October 1994, twelve CGIAR centres maintaining ex situ germplasm
collections placed designated germplasm accessions under the auspices of
the FAO as part of the International Network of Ex Situ Collections.
IPGRI played an important role in negotiating this agreement on behalf
of the CGIAR.
According to Article 3b of the FAO/CGIAR Agreement, each of the 12
CGIAR centres has to apply to the following two provisions: (a) "not
to claim ownership over the designated germplasm received, or to seek intellectual
property rights over that germplasm or related information" (e.g. research
results and information obtained from the persons or communities who had
donated the germplasm to the CGIAR centre); and (b) "to ensure that
any subsequent person or institution to whom he or she makes samples of
the germplasm available, is bound by the same provision."
In addition, Article 10 of the FAO/CGIAR Agreement explicitly states
that the centres have to accept responsibility for ensuring that any recipient
of the designated germplasm and/or related information is bound to the
same conditions as the 12 centres. A total of about 450,000 designated
accessions have been listed in the Annexes to the individual Agreements
which are part of the FAO/CGIAR agreement. After June 1995, institutes
and persons requesting material from the CGIAR centres will receive a Notice
Letter in which the new provisions are made clear. By signing the Notice
Letter the new user agrees with Article 3b of the FAO/CGIAR agreement.
However, designated germplasm is genetic material that has been acquired
or improved prior to the entry into force of the CBD. What about material
acquired after the enforcement of the CBD? Whereas the current agreement
merely consolidates the principle of genetic resources as "heritage of
mankind", exchange and use of postCBD material will surely fall under
specific provisions of both the Undertaking and the CBD related to sovereign
claims and a "fair and equitable sharing of the benefits". In this context
it should be noted that the CBD recognizes the primacy of Intellectual
Property Rights (IPR).
Rules for the exchange of post CBD material are currently being debated
in the FAO Commission on Plant Genetic Resources in coordination
with the Conference of Parties to the CBD, representing the countries
that signed and implemented the CBD. The FAO/CGIAR Agreement however does
not yet cover postCBD material. The Agreement does state that the
signing CGIAR centres are to "actively participate" in the debate
with the aim of reaching an arrangement which will "facilitate exchange
and utilization" and a "fair and equitable sharing of the benefits derived
from the commercial or other utilization of the germplasm".
Outstanding issues
As the FAO Commission on Plant Genetic Resources is now in the process
of bringing the Undertaking in line with the principles of the CBD, the
outcome of the debate between the FAO Commission and the Conference of
Parties to the CBD on access and exchange issues will have direct consequences
for the CGIAR policies. CGIAR centres will have to anticipate national
sovereignty claims from source countries that are supported by the CBD
for the material acquired by the centres after the CBD entered into force.
In the process of setting up national legislation, source countries could
start to impose restrictions on the distribution and collection of their
genetic resources.
It is in this context that the discussion on the application of MTAs
to the distribution of postCBD CGIAR material takes place. How can
the CBD provisions of sovereign rights and a "fair and equitable sharing
of the benefits" be linked with CGIAR's mandate to maintain the free availability
of germplasm? The solutions will be dependent on the outcome of other discussions
among the member states of the FAO Commission and CBD Conference of Parties.
An increasing number of CGIAR centres are distributing material from
their breeding programmes to commercial users. With regard to commercial
application of the material supplied, six centres are now drafting MTAs:
CIAT, CIP, CIMMYT, ICRISAT, IITA and IRRI. Considerable differences in
the interpretation of MTAs exist among these centres: some centres just
want to be informed about commercial uses, others want to be asked for
agreement.
IPGRI's proposal
In June 1995, Geoffrey Hawtin, IPGRI's general director, proposed a
multilateral framework which could provide a mechanism for the sharing
of benefits in cases in which the source country is known and the research
leads to commercialization.
With regard to material distributed from CGIAR breeding programmes,
Hawtin suggests categorizing material "notforprofituse"
and for "commercial use". Notforprofituse would include
farmertofarmer exchange, and varieties bred which are made available
without profit. Commercial use includes all cases where IPR protection
is employed.
Hawtin suggests applying a compensation mechanism to cover preCBD
material and putting "any benefits derived from commercial use (...)
into the envisaged international fund for the implementation of Farmers'
Rights." Hawtin warns against complex negotiation procedures which
lead to the equitable sharing of benefits. "In most cases such financial
benefits are not unlikely to be large, which (...) underlines the importance
of analyzing the transaction costs involved. (...) In any case the international
community will have to weigh the transaction costs against the possible
benefits."
Pandora's box
The question is what role CGIAR centres would take in case of a violation
of MTA rules by private or public users. A detailed compensation arrangement
as part of the CGIAR MTA policy can become very complex. The recent unofficial
MTA proposal of Barton and Siebeck includes optional clauses in which the
rights of a source country are protected by means of a "lineage norm" based
on the level of parentage between the improved variety and its genetic
source material. They mention a minimum lineage norm of 25 per cent.
Also, recipients that pursue IPR on genes or inventions deriving from CGIAR
material would not be allowed to assert IPR against the source country
for a number of years, unless the invention is made available within that
country at an equitable price.
In spite of their logical and reasonable content of MTAs, it should
be questioned to what extent they will really help developing countries
to benefit from their national sovereignty over genetic resources. MTAs
might bring more unexpected costs in terms of extra regulation than real
benefits if not quickly streamlined. The following points illustrate some
potential pitfalls in the implementation of the MTAs:
(1) Opposition by industry. Some users in industry might not
want to accept material on terms that restrict their right to exploit IPR
(especially patents) in the developing and/or source country. This applies
especially to cases in which CGIAR centres use the 'for research only'
clause in MTAs, thus preventing patenting of the transferred material or
of certain kinds of derived products. In these cases, commercial users
might want to circumvent CGIAR centres. There are many alternative suppliers
outside the CGIAR network. Elite material, to date, is usually exchanged
within breeders networks, outside the CGIAR system.
(2) Use of multiple resources. Barton and Siebeck state that
a 'lineage norm' can easily be challenged by users. Parentage in advanced
varieties depends on a host of different lines, each most often contributing
much smaller portions than onefourth to a new line. In the medical
sector private companies, such as Merck, tend to use material from one
source country (e.g. Costa Rica). But in the agricultural sector it is
typical for a variety to include genetic material from many sources. Applying
a similar approach to genetic material used in agricultural research would
lead to highly complex sharing formulas.
An additional argument could be that MTAs imply open access to information
on the pedigree of commercial varieties, which in the private plant breeding
industry is usually kept secret. How can a lineage norm function properly
while not violating this practice?
(3) Extent of rights. To what extent rights of source countries
as described in MTAs also include derivatives of subject material is unclear.
Advances in biotechnology can complicate negotiations on what is a derived
product. For example, circumstances could exist in which techniques are
used that can vary genetic expression in different hosts. The gene essentially
remains the same but its function differs. Also, techniques might be used
to identify similar genes or gene combinations in other species which then
are patented by the user who is thus circumventing claims. Barton and Siebeck
suggest that MTAs could contain "reach through" clauses in order
to prevent these specific cases and secure royalties to the source country.
However, the question to what extent a user will still be interested in
a MTA restricting its rights to use a patent again becomes relevant. The
issue would perhaps require a study on the options for integrating the
UPOV rules on "essentially derived varieties" and MTAs.
(4) Position of developing countries. The citation above mentions
"developing nations" as areas in which a patent owner may not seek protection
of its rights. This calls for a proper definition of which countries are
developing countries and which countries are not. Among the developing
countries as defined in the CBD several countries have advanced biotechnology
industries, such as Brazil and Malaysia. They will interpret the clause
as an impediment to their efforts to expand their regional or worldmarket
share. Apart from this, many developing countries do not (or do not yet)
possess juridical mechanisms to enforce national claims on technology transfer
or financial compensation.
Are MTAs as used by CGIAR institutes a useful mechanism to strike an
equal balance between free accessability and fair compensation? If CGIAR
centres prefer not to continue setting up joint ventures with commercial
users, the demand for complex MTAs will become less urgent. This in turn
would deprive source countries from the incentive to get involved in compensation
issues through sovereign claims.
Robin Pistorius
University of Amsterdam, Department of Political Science, Oudezijds Achterburgwal 237, 1012 DL Amsterdam, the Netherlands. Phone (+31) 20 525 4587; Fax (+31) 20 525 2086; Email r.pistorius@sara.nl
Sources
J.H. Baron and W.E. Siebeck (1994), Material Transfer Agreements
in Genetic Resources Exchange: The case of the International Agricultural
Research Centres. Issues in Genetic Resources No.1, May 1994. Rome:
IPGRI.
J.H. Barton and W.E. Siebeck (1995), Securing Genetic Resources Exchange Through Transfer Agreements. Not published.
FAO Commission on Plant Genetic Resources (1995), The International Network of Ex Situ Collections, and the CGIAR Centres. FAO document no. CPGR6/95/12 ADD.1, June 1995, Rome: FAO
G. Hawtin (1995), Approaches to Facilitating Access to Plant Genetic Resources and Promoting the Equitable Sharing of Benefits Arising from their Commercial Exploitation, within the Context of the CGIAR. Not published.
|
![]() |
| back to top |
|
|
|
|