Business Potential for Agricultural Biotechnology - Asian Productivity ...

Business Potential for Agricultural Biotechnology Products
Regulatory Environment
Two major regulatory milestones have been the establishment in 1990 of the National
Committee on Biosafety of the Philippines (NCBP) under Executive Order 430 and the issuance
in 2002 of Department of Agriculture (DA) Administrative Order No. 8: Rules and Regulations
for the Importation and Release into the Environment of Plants and Plant Products Derived from
the Use of Modern Biotechnology.
The NCBP formulated biosafety guidelines for conducting research and field testing involving
living organisms in 1991, and they are considered the strictest in the world (Galvez,
2005; Colmo, 2005; BMARC, 2005). Institutional Biosafety Committees were established, and
material transfer agreements were required of collaborating institutions. Licensing agreements
were brokered by the International Service for the Acquisition of Agri-biotech Applications
(ISAAA). To date the NCBP has approved a number of applications for research and a limited
number for field testing. The DA has approved several events regarding importation of GM
products, with Bt corn the first to be allowed for importation for direct use as food and feed, in
2002.
Figure 4 shows the process flow and major key players. NCBP, DA-Bureau of Plant
Industry, DA-Science and Technology Review Panel, DA-Bureau of Agriculture and Food
Products Standards, DA-Bureau of Animal Industry, Department of Environment and Natural
Resources (DENR), Department of Health-Bureau of Food and Drugs, and the Department of
Trade and Industry are involved in regulating biotechnology products. Mandatory GM labeling,
more of a consumer choice than a regulatory issue, has been proposed by some legislators/
senators and is now being discussed in public hearings. GM labeling has a major impact on the
growth and sustainability of SMEs as it increases production cost by around 10%–12%
(Estabillo, 2005).
Intellectual Property Rights
Laws have been passed concerning the protection of the rights of sources or stewards of
biodiversity—the raw material for biotechnology—and generators of biotechnology products
and related processes. EO 247, considered to be a landmark instrument, addresses benefit sharing
from biodiversity use. However, its guidelines were too restrictive for researchers and were
later superseded by Republic Act 9147, the Wildlife Resources Conservation and Protection Act
of 2001, which redefines bioprospecting to exclude scientific and academic research. EO 247
and RA 9147 are the country’s response to the threat of biopiracy, ensuring that benefits accrue
to the appropriate stakeholders.
The Intellectual Property Code of the Philippines (RA8293), signed into law in 1997, and
the Plant Variety Protection (PVP) Law, enacted in 2002, support technology innovators and
generators. At the institutional level, the Department of Science and Technology (DOST) has
formulated IPR guidelines for technologies generated through its competitive grants program,
acknowledging its ownership of these technologies and sharing the benefits through royalties
among the research institutions and the researchers and scientists. The DOST-Technology
Application Institute provides patent assistance to scientists; however, approval of such patents
can take more than a year. The Philippine Intellectual Property Office acknowledges that only
very few scientists apply for and become patentholders. The long approval process, the system
of reporting technologies generated by publicly-funded research, and limited knowledge about
the value of IPR protection are major constraints in IPR management in the NARS.
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