There are various pieces of legislation that are relevant to the biotechnology industry in Malaysia. The following offers a snapshot of some of the Acts in place that have a direct impact on the biotechnology sector in Malaysia.
The Biosafety Act of Malaysia (effective 1 December 2009) was put in place to govern and regulate the release and import of living modified organisms (LMOs) and products of such organisms in Malaysia. This was put in place to ensure safety and prevent unforeseen consequences as a result of the release or import of LMOs.
The Act is enforced by the National Biosafety Board (NBB), who decides all applications and matters under approval, under the advisement of the Genetic Modification Advisory Committee (GMAC).
The NBB and GMAC are made up of prominent leaders of Malaysia’s research institutions and experts in the fields of biosafety, biodiversity and biotechnology.
The Department of Biosafety under the Ministry of Natural Resources and Environment (NRE) acts as the secretariat for the NBB and GMAC, as well as the focal point for Malaysia’s biosafety framework.
To date, the only LMOs that have been released in Malaysia were genetically modified mosquitoEs to suppress the Aedes aegypti population for a mark-release-recapture field test in Bentong, Pahang.
For more information, please visit http://www.biosafety.nre.gov.my/law_regulation.shtml
Protection of New Plant Varieties Act
The Protection of New Plant Varieties Act 2004 (PNPVA) came into effect on 20 October 2008 and grants applicants exclusive breeder’s rights to their registered plant varieties for purposes of breeding, research and commercialization.
The Act provides intellectual property protection for plant breeders, particularly for those looking to exploit the rich local biodiversity for research in natural products and traditional/complementary medicine.
Such plant varieties need to be distinguishable from similar plant varieties and the duration of these licenses depend on the uniformity and stability of the variety.
The PNPVA also provides for enforcement should there be any incidence of infringement.
For more information, please visit http://pvpbkkt.doa.gov.my/
National Biodiversity Policy
The National Biodiversity Policy was officially declared in 1998 and is an important milestone as it marks Malaysia’s commitment to the developing itself into a world centre of excellence in conservation, research and utilisation of tropical biological diversity.
The Policy emphasized the need to conserve and sustainably utilize Malaysia’s biological resources for the purposes of safeguarding food security and maintaining environmental stability.
A copy can be downloaded from this link: http://www.arbec.com.my/NBP.pdf
National Biotechnology Policy
Please click on the link to learn more about the National Biotechnology Policy.