Biotechnology - Does the Law of the Jungle Apply?

Eow Khean Fatt provides a brief introduction to biotech and an overview of the current issues.


In this two-part article, Eow Khean Fatt treks through the biotechnology quagmire with the aim of helping the reader avoid missing the wood for the trees. Part I of this article provides a brief introduction to biotechnology and an overview of the current issues surrounding it.


How do you fancy the idea of molecule-sized robots that when injected in our bodies, will seek out and destroy mutant cells but repair damaged ones? Or what about an American biopharmaceutical company holding the patent for the Met-IL9 gene which renders human beings less susceptible to allergies and asthma? The above is no longer the subject of fiction. We are at the threshold of a new biotech revolution. Are our present laws sufficient to handle this new wave of legal issues arising from biotechnology?




In brief, biotechnology is the application of biological knowledge and techniques to make or modify a product, to improve plants and animals, or to develop microorganisms for specific uses.


There are two broad categories of biotechnology: traditional and modern. Examples of traditional biotechnology processes include fermentation, production of biofertilisers and biocontrol agents, cell and tissue culture. Modern biotechnology involves recombinant biotechnology or genetic engineering such as genomics, bioinformatics, transformation, marker-assisted breeding, diagnostics and vaccine technology.


The potential of biotechnology to humankind are endless. For example, with respect to food production, biotechnology may be used to produce ingredients, vitamins, starter cultures and enzymes for food processing. Scientists are even using biotechnology to produce more nutritional and better tasting food. In the agricultural field, biotechnology is used to produce crops with higher yields, longer storage life, stronger resistance to disease (thereby decreasing the need for pesticides), and better tolerance of poor soils or dry climates. In medicine, biotechnology offers methods of producing vaccines at a lower cost. For the protection of the environment, genetically modified bacteria may one day be used to convert organic wastes to useful products or to clean up oil spills.


Before examining the law governing biotechnology in Malaysia, it would be useful to have a brief overview of some of the topical issues governing the area of biotechnology in order to understand the legal issues that need to be addressed.




Biopiracy refers to the illegal collection of indigenous plants by corporations who patent them for

their own use. Naturally, instances of such actions have resulted in a strong sense of protectionism amongst local communities.


There have been many instances where patents by large MNCs have been challenged. Some of the well-known examples are mentioned below.




A 1995 patent for “Use of Turmeric in Wound Healing” was challenged in 1998after an investigation instituted by India’s Council of Scientific and Industrial Research (CSIR) which established that the use of turmeric to promote wound healing had been known for generations in India through Ayurvedic medicine. The CSIR challenged the patent on the grounds of “prior art” and produced ancient Sanskrit text to prove it. The ending was a happy one, the patent was withdrawn as the US Patent Office agreed that the invention was not novel.




The Neem tree is traditionally known in South East Asia (particularly among the Indian community) as a tree of many medicinal values. Patents were granted to a US company for extraction and storage processes of neem seed extracts. The controversy arose because Indian farmers were worried that the patents would prevent them from using neem as a source of homemade pesticide. The Indian government filed a complaint to the US Patent Office for copying an Indian invention which was later withdrawn when the Indian Government realized that the patents were for specific processes and would not prevent the use of neem in traditional ways.





Patents were granted to an American company, RiceTec Inc, for novel varieties of basmati rice, their plants and seeds, and a method of breeding and selection so that when cooked, the rice would have the qualities of traditional basmati.


The complaint filed was on the basis that the use of the name ‘basmati’ infringed upon the collective natural heritage of Indian and Pakistani farmers who grow traditional basmati rice, effectively allowing the company to steal the market from Indian traders. Consumers would be misled into buying American rice of Indian origin which could be passed off as possessing the same qualities of basmati rice.


Although a protest was lodged by the Indian government against the use of the basmati name, there was no formal challenge to the patent. The court is still deciding whether the use of the name “basmati” is geographically linked as it has become generic and is used to describe rice varieties in other parts of the world such as Thailand and Uruguay.




The advent of genetically modified (GM)foods, its benefits and its repercussions, have caused GM foods to be regarded with a mixture of scepticism and enthusiasm in recent years. Presently there are no regulations governing the development and use of GM Organisms (GMOs) in Malaysia. Application for the approval for GM crops or food is strictly voluntary.


According to the Genetic Modification Advisory Committee (GMAC), the Malaysian body responsible for the review and assessment of release of GMOs, only one product to date has received approval, a soybean product.


Regulatory mechanisms for GMOs are governed by the “National Guidelines for the Release of Genetically Modified Organisms into the Environment” (“Guidelines”), launched in 1997 by the Minister for Science, Technology and the Environment.


The Guidelines cover all GMOs (plants, animals, microbes, etc) at all stages of research and development; their use, handling, transboundary movements; and the release and placing in the market of GMOs and products containing GMOs. The Guidelines do not discriminate between imported or locally created GMOs. They were designed to supplement existing regulations for the import of agricultural, food and pharmaceutical products. Implementation of the Guidelines is carried out via existing enforcement mechanisms present in the various Ministries and agencies which are component members of GMAC, including the Ministry of Health, the Ministry of Agriculture, the Quarantine Department and the Department for Food Quality Control. Other members of GMAC comprise representatives from academia, R&D institutions, the Attorney-General’s office and an NGO (the Third World Network).


It is assuring to note that these Guidelines are currently being revised and drafted as a mandatory Biosafety Bill to ensure compliance rather than being on a voluntary basis.




It is hoped that this provides an introduction, albeit brief, into the world of biotechnology and the many issues implicated in its application. In the next issue of LEGAL INSIGHTS, we aim to provide an explanation of the current legal framework in Malaysia in respect of biotechnology and an overview of various international rulings, as well as the ethical concerns raised in respect of biotechnological advances and the ensuing legal challenges imposed by such concerns.



EOW KHEAN FATT ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it )



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