Section 4 of the Environment Management Act, (EMA) 1996 provides for the ownership and protection of natural and genetic resources.
The natural and genetic resources of Malawi shall constitute an integral part of the natural wealth of the
people of Malawi and
a) shall be protected, conserved and managed for the benefit of the people of Malawi; and
b) save for domestic purposes, shall not be exploited or utilized without prior written authority of
the Government.
9This provision makes it clear that no single individual, organization, even Government owns
the natural or genetic resources of Malawi. They are the property of the people of Malawi.
This is in accordance with the Constitution of the republic of Malawi, for example, which
vests all lands and territories of Malawi in the Republic, in the people of Malawi (section
207). The Government has supervisory and custodian functions in the same manner as a
trustee has, to ensure that such trust property is utilized and managed for the benefit of the
people of Malawi, who are its beneficiaries. In addition, and specifically targeting the
potential for biopiracy of genetic resources, the provision makes it clear that the exploitation
or utilization of the country’s natural or genetic resources must not be taken outside Malawi
for whatever purpose without prior consent or authority of the Government.
According to section 8 of the EMA 1996, the Minister responsible for environmental affairs
is the responsible authority for promoting the protection of the environment and sustainable
utilization and management of natural resources. He is also responsible for the
administration of the Act. Hence the protection, conservation, management including
sustainable utilisation of natural and genetic resources under section 4 is the responsibility of
the Minister of Natural Resources and Environmental affairs. Section 2 of EMA 1996
defines natural resources as the natural resources of Malawi wherever located while genetic
resources are defined as genetic material of actual or potential value. Hence biotechnology
which uses living organisms or substances from those organisms (genetic materials) to make
or modify a product is a technique that uses natural or genetic resources. It follows therefore
that the use of biotechnology is regulated by the EMA 1996 and administered by the
Environmental Affairs Department. This is the basis upon which the Biosafety Act, 2002
was drafted. Indeed the EAD could have drafted regulations under section 4 as read with
section 77 of EMA 1996 without promulgating a new statute and thereby spending more
time. EAD could however have delegated this particular function to the Commission under
the Science and Technology Bill, 2002 since EAD’s major function is that of sectoral coordination and not the actual management of natural resources. Indeed in terms of section 6
of EMA 1996, the Act does not in any way divest any lead agency of the powers, functions,
duties or responsibilities conferred on it by any written law. Such an approach could have
avoided the current conflict between EAD and the proposed Commission.
4.1 Procedures and Guidlines for Research
In fact in actual practice the NRCM has taken the lead in formulating policies and guidelines
for the prospecting, research and development issues pertaining to the use of the country’s
genetic resources. The NRCM was empowered under a Presidential decree of 1974 to coordinate all research activities in Malawi and to ensure that all research projects contribute
to national development. The NRCM has an inter-sectoral committee on Genetic Resources
and Biotechnology which is mandated to grant approvals for the collection and exportation
of genetic resources for research purposes. Unfortunately this Committee has no legal
mandate from any existing legislation and its activities may easily be challenged at the
moment. The approvals are required where foreign scientists come into Malawi to collect
genetic resources or when local scientists collect genetic materials and export them to
foreign research institutions. Through this approval mechanism it was hoped the country
could monitor and control loss of genetic resources and realize benefits of the research
results. The system did not work well as many foreign and local scientists continued to
collect and export genetic materials without proper approvals. In response, the NRCM
10produced Procedures and Guidelines for Access and Collection of Genetic Resources in Malawi, 2000
which regulates the collection of Malawi’s genetic resources by foreign researchers and
scientists to ensure that these resources remain valuable assets for socio-economic
development10
.
The procedures and guidelines provide for the roles and responsibilities of Affiliating
Institutions, being those institutions the researcher will work with; certifying institutions
being government institutions designated to control certain sectors of genetic resources; and
the NRCM. The latter grants research approvals while the certifying institutions issues
certificates of collection to the researcher and provides counterpart staff to accompany the
researcher while the affiliating institution provides the space and ‘home’ for the foreign
scientist. Any export of genetic material will require a licence from the Minister responsible
for Natural resources and Environmental Affairs. A non- refundable fee which defers
depending on the use of the research must accompany all applications. Hence academic and
research institutions attract a lesser fee than commercial or private institutions. The
procedures and guidelines outline detailed responsibilities to ensure that foreign research is
monitored and benefits the country. Some of the responsibilities of the various institutions
are:
9 to encourage productive research collection and collaboration with foreign recipients for
collected materials in Malawi;
9 to ensure that foreign researchers on field trips are always accompanied by appropriate
staff paid for by the foreign researcher;
9 to verify that duplicate specimens are deposited with an appropriate designated local
research institution;
9 to ensure that endangered species, including special studies such as those involving
sharing of certain traditional knowledge, are not collected or carried out without a valid
waiver from NRCM;
9 to ensure that all research on genetic resources has the necessary approvals, certificates
and or, where necessary, export licences;
9 to ensure that the researcher compiles a complete list of all collected genetic resource
materials and a copy submitted to NRCM within three months;
9 to ensure that the researcher carries out his investigations in accordance with agreed
methods and set guidelines;
9 where the research involves use of traditional knowledge, to ensure that prior informed
consent has been obtained from the communities concerned.
10 See NationalResearch Council of Malawi (2000), Procedures and Guidelines for Access and Collection
of Genetic Resources in Malawi (National Research Council of Malawi, Lilongwe) pp. 1-3.
11These guidelines and procedures are exhaustive and may seem cumbersome and
bureaucratic. However, considering that it is very easy for foreign researchers to ‘cut corners’
where only one institution is involved and thereby frustrate the policy, it is essential that an
elaborate framework such as this be implemented and complied with.
In addition to the guidelines above the NRCM is promoting the use of agreements to
regulate the relationships between the collectors, NRCM and their foreign researchers .
These instruments include:
9 research agreements which define research collaborations between local research
organizations and their foreign partners and rights and obligations between the parties in
case of private sector collections; and
9 material transfer agreements which define facilitation access to genetic resources for
non-commercial use such as taxonomy/ethno botany or for routine purposes such as
teaching.
The NRCM is in the process of drafting specimen agreements for this purpose. The
specimens that have been drafted include:
9 Material transfer agreement for academic collectors for research use only
9 Material transfer agreement for non-profit making collectors
9 Research agreement for profit making collectors
9 Community resource rights clause for use with collection on customary land
9 Material transfer agreement for personal use with no possibility of third party transfer
9 Agricultural germplasm agreement for use with non profit collectors
9 Immigration proforma contract
These drafts are intended to provide guidance for different researchers and their foreign
partners. The Genetic Resource and Biotechnology Committee will be the authority to
approve research agreements. The approved agreements endorsed by the Committee while
those rejected will be returned for revision. Hence an agreement will only be valid after being
signed by the parties and endorsed by the Committee. According to the procedures and
guidelines, the Committee may withdraw certificates without notice or giving reasons to the
researcher. This provision can easily be challenged since it offends principles of natural
justice which apply under all situations under the Malawi Constitution.
Finally, the procedures and guidelines require the researcher to acknowledge Malawian input
into the research on publications resulting from the research. Copies of the publications,
including raw data in the case of academic non-proprietary research; or data or a subset of
data, in case of proprietary research, must be sent to the affiliating institutions in a timely
12manner. These provisions ensure that the results of the research are stored in Malawi and
therefore available for future reference.
These procedures and guidelines will have to be revisited in the light of the Science and
Technology Policy, 2002 and the Science and Technology Bill, 2002. They may be enacted as
regulations so that they have some force of law and can therefore be enforced in terms of
the existing legislation.
4.2 Material samples and technology change
The procedures, guidelines and draft agreements reflect growing attempts by developing
countries to ‘tame a slippery beast’11. It is widely acknowledged that what is lucrative is not
the ownership of a sample rather the information that is extracted from the sample and it is
the control of access to that information that is critical. Such transformation of sample
material is beyond the ability of centers of origin such as Malawi to track. Hence any
agreement to govern the exchange of such materials must deal not only with the multiplicity
of transactions through which the sample may go but also ‘12a resources that is inherently
fluid, immutable and dynamic’. The agreements that are being drafted continue to treat the
resource as a sample and not information. Hence they cater for compensation in form of
fees or royalties per sample. Such fees will generally be low since it is rarely certain that the
sample will yield something very valuable. Even when it does, the claimants assume the
collector will go back to the source for more in situ collections. However technology is
making it easier to replicate the materials in the laboratory. And there is no guarantee that
the source will be the only source. Further, there is little likelihood that sources of origin of
materials can effectively control the successive use of the materials. Once the material has
been handed over to a collector, there is little prospect that its use may be controlled.
Material Transfer Agreements may be used to make these agencies to declare the sources of
materials and to pay compensation to the suppliers. The situation may however be further
complicated if a collecting agency goes into bankruptcy or is subsequently found to be
bogus. Very few developing country institutions have the capacity to search for details and
verify and therefore be able to monitor. Finally, technology is making it possible to store
samples for a long time. By the time it is used the suppliers and the agreements will be very
dim history indeed13. These are very real challenges to the procedures guidelines and the
agreements being drafted.
4.3 Intellectual Property, indigenous knowledge and biotechnology
As observed in the foregoing paragraph, access to and control of information, especially
privileged information which provides a competitive advantage for a firm discovering a new
product, is the most important form of wealth and has created a wholly new economy. This
has brought two separate but related problems for poor developing countries such as
11 Parry, B(200) “The Fate of the Collections: Social Justice and the Annexation of Plant Genetic
Resources” in Zerner, C (2000) (ed) People, Plants and Justice: The Politics of Nature Conservation
(Columbia University Press, New York) p. 374 at387.
12 Ibid, p393.
13 Ibid pp. 386.
13Malawi. Not only is access to such technology not equitably distributed, but also the
intellectual property rights regime which enables the holders to exclude others from use of
such technology makes it very difficult for developing countries to catch up. This in fact is
the context within which the World Trade Organisation’s agreement on Trade Related
aspects of Intellectual property Rights (TRIPS) was adopted. The agreement allows for the
‘commodification and monopolization of the embodied alterations made to the genetic and
biochemical information’14. Such information is being patented by corporations and private
research institutions mainly in the developed world as new products in their own right.
“(P)ower and profit derive from the ability to actively restrict the circulation of information
through the use of the patent”15. It is essential therefore for a country such as Malawi to deal
with the question of intellectual property rights as an issue of development control and not
merely as a private commercial matter. The availability and access to life saving medicines
and sources of livelihoods may be adversely affected by the application of intellectual
property rights16
.
The Science and Technology Policy recognizes the importance of intellectual property rights,
especially patents, as a source of technological information essential for the beginning of any
project for new product development. The Policy seeks to promote the use of patents for
upgrading technology especially in the industrial sector of the economy. It stipulates a
number of strategies for achieving this objective. These include setting up sound and user
friendly patent information, assist in reviewing intellectual property legislation to make it in
line with international practice and enhance interaction between Malawian inventors and
those from other countries.
While noting the potential conflicts between cultural beliefs and scientific challenges, the
Policy recognizes the significance of indigenous knowledge systems especially in relation to
traditional medicine. The policy therefore calls for the identification, development and
protection of indigenous knowledge systems. In particular the policy recognizes the inherent
weakness of the classical “western” intellectual property rights regime to protect indigenous
Knowledge systems whose ownership structure is largely communitarian in character and
therefore cannot be protected by the individualistic western intellectual property regimes.
The Policy stipulates a number of strategies for achieving the identification, development
and protection of indigenous knowledge systems. These include commissioning studies to
identify, isolate and document IKS, promote training in IKS, establish incentives to promote
generation and utilization of IKS and develop legislation which protects rights of origin of
IKS.
It is noteworthy that although the Policy identifies the potential conflict between IKS and
the classical intellectual property regimes and therefore calls for the protection of IKS
through appropriate legislation, it does not seek to harmonise the apparent conflict, which
has been widely recognised, between the WTO TRIPS Agreement and the protection of
biotechnology resources in the developing world. In fact the Policy calls for the amendment
of the existing Patents Act and related legislation in order to comply with the TRIPS
14 Ibid, p. 386.
15 Ibid.
16 See UK Commission on Intellectual Property Rights (2002) Integrating and Intellectual Property Rights
and Development (Commission on Intellectual Property Rights, London).
14agreement. It would be important for the Policy to specifically recognize the conflict that the
TRIPS agreement has brought about especially with respect to biotechnology prospecting
and the patenting thereof and then deal with specific policy objectives which the Malawi
Government needs to follow with respect to the Agreement. In particular, the Policy should
have paid specific attention to the response offered by African countries in the OAU Model
Legislation for the Protection of Community, Farmers and Plant Breeders Rights, to utilize a
window provided by the WTO TRIPS article 27 (3) (b) to develop sui generis for their own
peculiar circumstances.
Further, the Policy does not address the institutional capacity building for IKS in Malawi.
Organizations such as the Herbalists Association of Malawi and the farmers organizations
which are directly involved in issues of IKS and the manner in which the intellectual
property regime affects their work ought to be facilitated. These need to be sensitized and
provided with the necessary framework and support to enable them contribute effectively to
the implementation of the Policy.
According to cepa