The Policy recognizes the important contributions that modern biotechnology is making to
production systems in agriculture and health delivery. It further notes that apart from the
establishment of the Molecular Biology and Ecology Research Unit established at the
University which is an important entry point for the country to adopt third generation forms
of biotechnology, the country’s capacity in biotechnology has been limited to first and
second generation forms of biotechnology such as fermentation and tissue culture.
The Policy further recognizes the significant steps taken by the Malawi Government in
developing a legal framework governing biosafety issues in Malawi. Parliament passed the
Biosafety Act at its last sitting in October this year. The Act is awaiting signature by the
President and should become operational fairy soon. The Policy however outlines various
strategies to promote the development of biotechnology in Malawi. These include establish
and or strengthen centers of excellence in specific areas of biotechnology, increase awareness
in biotechnology, enhance human resources capacity and establish a national programme of
action, capacity to monitor and evaluate programmes of international co-operation in
biotechnology. It is clear therefore that the Science and Technology Policy was drafted and
adopted more or less at the same time that the Biosafety Act was enacted. Yet the
conflicting mandates discussed earlier were not considered.
5.1 The Biosafety Act 2002
Following the country’s signing of the Biosafety Protocol in 2000, a Biosafety Bill was
drafted by the EAD after wide consultations with various stakeholders. Parliament enacted
the bill at its last sitting in October 2002. This part reviews the major provisions of this
legislation with specific attention to issues of stakeholder involvement in its implementation
and enforcement.
Part II deals with the institutional framework and administration of the legislation including
the specific functions and duties of the responsible agency. The Minister responsible for
Environmental Affairs is given overall responsibility over the administration of the Act “and
15such other officers subordinate to him as may be appointed under this part”. This provision
is repeated under section 5. The Minister is vested with several functions under the Act.
These include formulating and reviewing guidelines on biosafety, liaising with institutions
involved in biosafety, promoting awareness in biosafety and approving safety aspects of
import, export, manufacture, processing and selling of genetically modified organisms.
The Ministry of Natural Resources and Environmental Affairs, especially the
Environmental Affairs Department is the agency responsible for co-ordination of
environment and natural resources issues in Malawi under the Environment Management
Act 1996. Issues of biotechnology and biosafety in Malawi are a responsibility of different
government or quasi government agencies. These include the departments of forestry,
agriculture, health, trade and industry, the NRCM and statutory bodies such as the Malawi
Bureau of Standards, the University of Malawi and the National Herbarium and Botanical
Gardens. Within these departments and parastatal organizations, there are specialized
research institutions which deal specifically with biotechnology products.
Hence, the Forestry Research Institute of Malawi (FRIM) as the research arm of the
Department of Forestry is involved in forestry plant breeding and propagation; Chitedze and
Bvumbwe Research stations and the Central Veterinary Laboratory of the Ministry of
Agriculture are involved in agricultural plant and animal breeding as well as animal disease
diagnostics; within the University of Malawi, Bunda College of Agriculture, Chancellor
College and College of Medicine are involved in research in plant and animal breeding,
molecular markers and diagnostics respectively.
There is therefore the need for an institution that can co-ordinate the development of
biotechnology in terms of policy direction, funding framework and issues involving
international co-operation. The EAD as the agency responsible for co-ordination of
environmental issues was given that role. There is need however to harmonise the
provisions of the Biosafety Act, 2002 and the Science and Technology Bill, 2002 to
streamline functional responsibilities of various agencies.
5.2 The Biosafety Fund
Part III establishes a Biosafety Fund whose objects shall be the safe management of
biotechnology activities. In particular, section 12 stipulates the uses to which the fund may
be employed. These include:
♦ Research and training to promote the safe management of biotechnological activities.
♦ Acquisition of land, equipment, materials and other assets for the construction of
buildings in order to promote the objects of the fund;
♦ The cost of any scheme which the Minister considers to be in the interest of the safe
management of biotechnological activities;
It has been established that the country’s human resources and infrastructure facilities in
biotechnology management are very inadequate (Maliro M et. al, 2001). The Fund would
16therefore cater for a major gap in the country’s efforts to promote and safely manage
biotechnology.
The sources of the Fund are stipulated in section 7 (2). These include
♦ Monies appropriated by Parliament for the purpose;
♦ Fees, levies and penalties payable under the Act; and
♦ Voluntary contributions and donations received for the purposes of the Fund.
The sources are, on the face of it, adequate to constitute a viable fund for the management
of biotechnological activities in the country. It is noteworthy, however, that a number of
pieces of legislation pertaining to environment and natural resources management in the last
few years have established funds to cater for the promotion of statutory objects under their
enabling legislation but none of these funds are in place. These include the Environmental
Fund under the Environment Management Act, the Fisheries Fund under the Fisheries
Conservation and Management Act, 1997 and the Forestry Fund under the Forestry Act
1997. It is not certain therefore that Government will find the necessary resources to
establish the Biosafety Fund. Moreover, considering the obscure nature and hence the kind
of priority that may be placed on it by Government, it is unlikely that we can see a Biosafety
Fund soon.
This is a situation which requires lobbying by civil society including institutions that are
involved in biotechnological activities to ensure the Fund is constituted and utilised for the
purposes for which it has been established. Hence voluntary contributions and donations
can be made to the Fund through civil society fund raising as well as those of the institutions
involved in biotechnological activities, whether governmental or quasi government. These
organisations can be involved in joint fund raising activities through project proposals. Such
joint activities can attract funding from diverse sources and increase the country’s chances of
advancing in biotechnological activities.
There is however one major obstacle which can significantly reduce civil society enthusiasms
for such fund raising. The Fund is purely governmental (section 9) and does not allow any
space for civil society participation in its set up or management. This is a major short fall in
the legislation and will adversely affect fund raising activities. Most donors and contributors
are demanding transparency and accountability in funds management. Due to government
record in previous funds management, some donors or potential contributors would not be
very comfortable with a wholly government managed fund.
The presence of civil society in the management of the fund would have encouraged donors
to contribute to the Fund. Moreover in view of the fact that government activities in
research including and especially new research such as biotechnology are unlikely to be
increased due to funding constraints, it would have been more meaningful to seek to
facilitate civil society, private and quasi governmental research activities through the Fund. A
trust fund encompassing the participation of major stakeholders would have been more
17participatory and facilitate more players in the promotion and safe management of
biotechnology research.
5.3 Licences and Permits
GMO licences
Part IV of the Act requires that a person shall not engage in the following activities without
obtaining and except in accordance with licence granted under this Act, namely:
♦ genetic modification of organisms (GMOs);
♦ importation, development, production, testing, release and use and application of
GMOs; and
♦ use of gene therapy in animals or human beings
The Minister responsible for environmental affairs is the licencing authority responsible for
the granting, renewal, variation, suspension and revocation of licences. In certain special
cases the Minister may grant a permit to an applicant to engage in activities stipulated above
without a licence. Permits may be issued for scientific research and experimental purposes,
and emergency supply of food for human beings. Such a permit may exempt the holder
from any of the provisions of the Act.
Other Licences
The Act further requires business retailers to take out a product licence if they want to be
engaged in trading in GMOs or their products. Section 19 provides that no person may
engage in the business of selling, exporting, supplying or procuring for sale, export or supply
or manufacture of GMOs or their products without a licence issued under the Act. There are
also requirements for licences for persons engaged in the business of manufacturing of
GMOs or their products, wholesale dealing in GMOs or their products and retail pharmacy
business. The Minister may however specify in the Gazette circumstances in which
importation of GMOs or their products may be exempted from the provisions of section 19.
The Act stipulates in some detail the matters the Minister shall consider before issuing a
licence under the Act. These relate, inter alia, to the safety, efficacy or quality of GMOs or
their products as well as the premises, procedures and equipment to be used (section 22). In
addition the Minister shall consider whether the person is a fit and proper person to deal in
GMOs or their products under the particular licence applied for (section 23).
Upon being satisfied of these matters the Minister shall then issue the licence subject to such
general or special conditions as he shall deem fit. The general or special conditions that the
Minister may impose on the licence may provide for adequate safeguards to ensure that the
GMOs or their products will be properly managed. They provide for space for the
compromise where it may appear to the Minister that giving a blanket licence will threaten
the environment such as plant and animal life including human beings.
18The Act however does not provide for the participation of either governmental or quasi-
governmental institutions in considering whether or not a licence should be granted. There is
no provision for members of the general public or civil society to lodge objections to
applications for GMO or other licences under the Act. Although the list of matters to be
considered by the Minister before issuing a licence are exhaustive and may assist in GMO
environmental impact assessment, there is clearly need to ensure that other stakeholders who
may be affected by the licence provide in the decision making process and voice their
concerns accordingly.
Hence the only available remedy is an appeal under the Act. However, since the question of
an appeal is post facto, any relief granted may come too late after damage has already occurred.
That is why an EIA style licence and permit application process would be much more
preferable and effective as not only can it reduce potential harmful effects of GMOs and
their products but it can also provide the necessary mitigation measures and prepare the
affected communities for the foreseeable impacts of the GMOs.
5.4 GMO Labeling and Advertisement
According to section 26 all containers or packages used in the course of business of selling
or supplying GMOs or their products must be properly labeled in accordance with
regulations made under section 41. Subsection 2 prohibits false descriptions or marks of
containers or packages of GMOs or their products and descriptions or marks of GMOs or
their products which are likely to mislead as to their nature, quality, efficacy or quality. This
also applies to any leaflets supplied with together with GMOs or their products (section27).
Any violation of these provisions is an offence and attracts a penalty as provided for under
section 40 of the Act.
The Act further provides power for the Minister to make regulations which may prohibit
advertisements that are likely to lead to the use of GMOs or their products or of a type that
may be stipulated in the regulations. The regulations may also prohibit use of words or
phrases likely to mislead the public as to the nature or effects of the organisms or products
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