A. PREAMBLE
Malawi is endowed with rich biological diversity and genetic resources with
great potential to provide diverse chemicals, enzymes and genes. These resources,
if used properly and in a sustainable manner, can contribute to the socio-economic
development of the country. The uses for these resources can vary from plant
extracts for herbal products, naturally occurring enzymes in industrial manufacturing
to organic molecules used to design new pharmaceutical drugs. They can also
be used as a source of diverse genes in the breeding of crop and animal varieties
with high performance.
Malawi is party to several international treaties, conventions and agreements
that have implications on genetic resource utilisation and exploitation. These
include the Convention on Biological Diversity (CBD) to which Malawi acceded
in 1992. The CBD places great emphasis on national and community sovereignty
over genetic resources and biodiversity and moves away from the notion that
these resources and knowledge are the common heritage of mankind. The World
Trade Organization (WTO) Agreement on Trade-Related Intellectual Property Rights
(TRIPs) calls for parties to adopt a wide range of intellectual property rights
regimes, including patents, plant breeders rights, and trade secrets. Agricultural
genetic resources agreements are treated within the International Union for
the Protection of New Variety (UPOV Convention), which defines rights to new
varieties which may be created by plant breeders to which Malawi is not yet
a party. In addition, the non-binding International Undertaking on Genetic
Resources explicitly recognizes the concept of rights to traditional land races,
which may be created or preserved by rural and indigenous communities throughout
the developing world.
These treaties bind the
government of Malawi under International Law to enact the necessary regulations
for their implementation.
Hence since 1992, the Government
of Malawi (GOM) and key stakeholders on the environment have been devising
new approaches and formulating the requisite policies and legislation to guide
Malawi forward in its environmental management endeavours. The National Environmental
Action Plan (NEAP), adopted in 1994, documented the depletion of the country’s
natural resources and provided a guideline for action-oriented programming.
The NEAP included loss of biodiversity among the nine major environmental problems
in Malawi. The National Environmental Policy (NEP), approved by cabinet in
1996, places emphasis on the management of the environment and genetic resources
by the community. The NEP is enshrined in the Environmental Management Act,
approved by Parliament in 1996. The Act, among other things, imposes restrictions
on the collection and export of genetic resources without the prior informed
consent of the responsible Minister. The Act ensures that the country’s
genetic resources are protected and sustainably utilised for future generations.
It is, therefore, important that this protection adequately covers all avenues
that can be used by unscrupulous prospectors to collect and export Malawi’s
valuable genetic resources. It is also important that proper documentation
be kept on genuine research efforts that involve the collection and export
of such genetic resources.
The National Research Council
of Malawi (NRCM) is empowered under the 1974 Presidential Decree to coordinate
all research
activities conducted in this
country and to ensure that any research project proposed for execution is geared
to national development needs and goals. The NRCM’s Genetic Resources
and Biotechnology Committee (GRBC) is, therefore, mandated to grant approvals
for the collection and exportation of genetic resources for research purposes.
Such approvals are granted only on advice from designated national institutions.
Through this mechanism the GRBC
is expected to monitor
and document genetic materials that are collected or researched upon by foreign
scientists including
those dispatched by local researchers to foreign institutions. However, this
system is not being fully implemented and as a result, foreign researchers
and institutions have continued to collect Malawi’s genetic resources
without proper approvals and permits. In addition, local researchers have
continued to export and exchange genetic resources without proper approvals
and records.
This has led to situations where genetic resources are being lost without
proper records and without Malawi realizing benefits from the results of
such research
and the commercialization of the research results. It has, therefore, become
necessary to develop guidelines that sets up the procedures for the seeking
of approvals for research and collection of genetic resources. The guidelines
are intended for use by:
Foreign scientists and research institutions that plan to conduct research
involving the collection of genetic resources;
Local scientists and research institutions that plan to collect and export
genetic resources for analysis or as part of an exchange programme with a
foreign institution, scientists;
Local scientists
and research institutions that are funded by an external source on research
projects involving the collection
of Malawi’s genetic
resources.
Malawi Government officials at ports of entry
The guidelines are not intended to restrict innovative research in genetic resources but serve to ensure that Government is committed to promote research in the proper management and sustainable utilization of biodiversity for research so that the country is benefiting from the utilization of its resources.
B. OBJECTIVES OF THE GUIDELINES
The Council expects that research that involves the collection of Malawi's genetic resources by foreign researchers and scientists follow set guidelines to ensure that genetic resources remain valuable assets for socio-economic development. In essence, the guidelines shall serve to achieve the following objectives:
Ensure that research
of Malawi's genetic materials does not lead to loss of biological diversity.
Ensure that exchange
of genetic resources germplasm and commercialisation of research results
are done in such a way that Malawi benefits economically
from whatever is exported.
Encourage the establishment
of gene banks and genetic data banks (in-situ and ex-situ) and formation
of strong linkages with the banks including
the SADC gene bank.
Ensure that research
projects that involve exchange of genetic resources and germplasm are
effected in a manner that encourages collaboration
with
foreign researchers.
Ensure that expatriate
researchers/collectors work closely with competent local researchers
to safeguard Malawi's interest.
Ensure that research
projects on genetic resources are only those that are geared towards
Malawi’s socio-economic development and that their execution
does not lead to fragmentation and duplication of research efforts.
Encourage research
projects on proper management, conservation and sustainable utilisation
of genetic resources
C. CATEGORIES OF RESEARCHERS
For purposes of these guidelines researchers shall be categorized as follows:
1. Foreign researchers or institutions
These are researchers or institutions wishing to conduct research that involves the collection and/or export of genetic resources from Malawi. These are sub-divided into the following:
Academics and Research Institutions:
These are students/scholars, academic
and research institutions outside Malawi seeking to conduct research that
involves the collection and/or export of genetic resources for academic
research use.
Non-Profit institutions:
These are institutions outside Malawi seeking
to conduct research that involves the collection and/or export
of genetic resources for natural products research and development. These
include
registered charity organisations, NGOs and trusts.
Commercial Public or Private Institutions:
These are commercial companies
outside Malawi seeking to conduct research involving the collection
and/or export of genetic resources for natural products research and development
and eventually to market the products on the international markets.
2. Local researchers or institutions
These are researchers ordinarily resident
in Malawi and institutions wishing to export genetic resources to researchers
and institutions outside Malawi for analysis or on exchange basis.
Academics and Research Institutions:
These are students/scholars,
academic and research institutions within Malawi seeking to export genetic
resources to foreign institutions for academic and research use.
Non-Profit institutions:
These are institutions within Malawi, requesting
permission to export genetic resources for natural products research and
development. These include registered charity organisations, NGOs and
trusts.
Commercial
public or Private Institutions: These are companies within Malawi seeking to export genetic resources
for natural products research
and development and eventually to market the products to international
markets.
D. PROCEDURES AND REQUIREMENTS FOR APPLICATION
The procedure of approval of research that involves
collection of genetic resources shall involve several institutions including
Affiliating institutions, Certifying institutions and the National Research
Council of Malawi (NRCM). Affiliating institutions are those that the researcher
will work with in conducting research work. These institutions will need to
have requisite resources (equipment, facilities and staffing) to undertake
the proposed work. Certifying Institutions are those government institutions
designated to control certain sectors of genetic resources. A list of those
is provided in appendix 1. These institutions will review research proposals
prior to submission to NRCM. Following approval by NRCM, Certifying Institutions
will be required to issue a certificate of collection to the Scientists in
addition to providing the counterpart staff to accompany foreign researchers
on collection mission. The NRCM’s GRBC will be responsible for approval of
research programmes involving collection of genetic resources. In addition,
foreign and local researchers wishing to export any genetic resource will need
to seek export license from the minister of Natural Resources and Environmental
Affairs as stipulated by the Environmental Management Act. All applications
for research on genetic resources shall meet the following requirements:
The local researcher shall be from or affiliated to a recognized
research or academic institution while foreign researchers shall be those
that are affiliated to a recognised foreign and local research or academic
institution.
Each application shall be submitted to the Council, through the affiliating
institution, at least 2 months before the commencement of the research and
shall include a curriculum vitae of the lead researcher.
A non-refundable fee submitted to the National Research Council of Malawi
as follows shall accompany each application as follows:
Foreign researchers and institutions wishing to conduct research involving
the collection and/or exportation of genetic resources in Malawi.
Academics and research institutions -US$ 150
Non-profit institution -US$ 300
Commercial public or private institution-US$ 600
Local institutions wishing to conduct research involving
the collection and/or exportation of genetic resources outside Malawi.
Academics and research institution -US$ 50
Non-profit institution -US$ 150 Commercial public or private institution -US$ 200
The fees are subject to review from time to time.
Each application shall be submitted according to the format in Appendix
2. In addition it shall include an attachment of the research project details
including title, names, researchers, objectives, description of problem area,
hypothesis, materials and methods (methodology), workplan, expected output,
CVs.
Each application by foreign researchers shall include evidence of affiliation
to local and foreign academic or research institution. It will be up to the
applicant to negotiate for the affiliations. The Council regards the affiliation
as a contract between the foreign researcher and the affiliating institution.
Approval shall not be granted unless affiliations are confirmed by the local
affiliating institution.
The applicant shall specify the quantity of the genetic
resources to be collected. The Chairman of the GRBC shall, however,
reserve the ultimate right and authority to authorize the collection
of the genetic resources applied for in the quantity he/she shall
deem reasonably necessary depending on the nature and scale of the
reasons for which the collection is being sought for.
E. RESPONSIBILITIES OF AFFILIATING AND CERTIFYING INSTITUTIONS
Encourage productive collection and research collaborations
with foreign recipients on collected materials in Malawi.
Ensure that foreign researchers on field trips are always accompanied
by local counterparts. The researchers must meet expenses of the counterpart
such as transport, accommodation and daily allowances.
Verify that duplicate specimens of all collections are deposited with an
appropriate designated Malawian research organisation/ institution.
Ensure that endangered species listed in the Appendix to the Convention
on International Trade in Endangered Species and Malawian endangered species
are not collected without a valid waiver obtained from National Research
Council of Malawi (NRCM). The certifying organisations will from time
to time inform GRBC on areas defined as special studies. No Collection
of
rare
endangered germplasm is allowed without a valid waiver obtained from
NRCM.
In terms of genetic resources, special studies are defined as those
studies involving:
sensitive areas such as sharing of certain traditional knowledge
on use of genetic resources;
endangered rare plant and animal species, human bodies/parts.
Ensures that all research on genetic resources has necessary approvals and certificates before commencement of the project and in case of export, that a valid export license is obtained from the responsible Minister.
Ensure that the researcher compiles a complete list of all collected genetic
resource materials and a copy submitted to the National Research Council of
Malawi within three months of completion of field work.
Ensure that the researcher carries out his/her investigations according to
the agreed research methods and collect the genetic materials following the
set guidelines; have the progress of his/her investigations monitored; affiliating
institution to make available to NRCM 3 copies of any research findings obtained
from the research work.
Ensure that prior informed consent (PIC) has been obtained from communities/authorities
under whose jurisidiction falls the desired genetic resources prior to
commencement of any research work that involves the collection of such resources.
Must ensure that these guidelines are adhered to for proper management
and sustainable utilization of Malawi's genetic resources and traditional
knowledge.
F. RESEARCH AND MATERIAL TRANSFER AGREEMENTS AND CERTIFICATES
Research and Material Transfer Agreements shall be used to define research collaborations between local research organizations and foreign research partners and to define rights and obligations respectively between parties in the collection and use of the genetic resources. In supporting the cause and spirit of these national procedures and guidelines for access and collection of genetic resources as set out in here, collectors shall be obliged to sign any relevant material transfer agreement that shall be available in force from time to time. These agreements shall be provided by NRCM or any of the certifying institutions. In absence of these material transfer agreements, the general procedures and guidelines as set out in here shall wholly apply but subject to conditions, rules and regulations that Government of Malawi shall deem necessary to put in place at that time. Designated certifying organizations (provider) shall facilitate the administering of the material transfer agreements at an institutional level and shall forward them to the chairman of the Genetic Resources and Biotechnology Committee for final certification and endorsement.
The Genetic Resources and Biotechnology Committee shall be the sole authority
to approve Research and Material Transfer Agreements on genetic resources.
Secretariat shall review requests for certificates, Research and Material
Transfer Agreements signed by recipient and provider.
The GRBC shall co-opt relevant stakeholders such as legal experts, certifying
organisations, NGOs, local communities, or the private sector, as appropriate
to review Research and Material Transfer Agreements.
Approved Research and Material Transfer Agreements shall be endorsed by
the GRBC. Rejected ones shall be returned to the provider organisation with
a detailed description of revisions required for approval.
Material Transfer Agreements administered by or on behalf of the GRBC
as specified above shall be valid upon signing by both the provider and
recipient.
G. WITHDRAWAL OF CERTIFICATES
The GRBC reserves
the right to withdraw any certificates without notice or giving reasons
to the researcher/collector or institution.
Violators of Malawi's
genetic resources regulations shall be punishable by fine or imprisonment
or both and may be subject to further prosecution as
prescribed by the Environmental Management Act.
H. PUBLICATIONS AND DATA
External researchers are required to acknowledge Malawian collaboration and
participation on publications written out accordingly.
Four copies of all publications arising from the collections in Malawi
shall be sent to the affiliating institution in a timely manner
In the case of academic, non-proprietary research or otherwise, all raw
data generated by the recipient shall be deposited in a timely manner with
the affiliating
institution as provided.
In the case of proprietary research, data or a redacted subset of data
generated by the recipient shall be deposited in a timely manner with
the affiliating
institution according to the terms of the negotiated Research Agreement.