Biotechnology and Biosafety
Attributes
Medium: Animals, Plants and/or Others
Country: Philippines
Analytical Framework(s): Other
Study Date: 2004
Publication Date: 2005
Major Result(s)
Study Note: The aims of this study were: a) to determine the prospects for biotechnology product development (BPD) in the Philippines; b) to examine the effectiveness of Philippine biosafety regulatory mechanisms, the capacity of local institutions to implement biosafety guidelines, and the extent of environmental risk analysis conducted before the commercial release of Bt corn was approved; c) to study the mechanisms used in intellectual property (IP) management in the Philippines and how these can be used to deter illegal importation and commercialization of untested biotechnology products and; d) to recommend measures to further improve the Philippine biosafety regulation system (PBRS) and provide adequate safeguards to minimize environmental risks.
Study Details
Summary: The application of modern biotechnology is recognized as the potential answer to the growing problems of food security (i.e., the ability to provide adequate and affordable food), poverty and environmental degradation, particularly in developing countries. The challenge for these countries is how to benefit from the application of these technologies considering their lack of necessary biosafety regulation and intellectual property management capacity. The aim of this study was to find out if the Philippine biosafety regulation system is effective, if it protects intellectual property rights (IPR) and if it has the capacity to respond to the potential increased pace in biotechnology product development. The results of the study show that: (a) the current Philippine Biosafety Guidelines are consistent with the Cartagena Protocol on Biosafety (2000); (b) efforts are being made to enhance human resource and infrastructure capacity for research and development, and biosafety regulation; (c) due to resource limitations, research and development efforts focus on testing the applicability of technologies developed in other countries to local conditions. These studies are less costly but can contribute significantly to the knowledge and science on biosafety; (d) Bt corn 1 , the first genetically modified crop approved for commercial release in the Philippines, underwent several stages of risk assessment before it was approved for commercial release; and (e) the intellectual property rights related to biotechnology are protected under the Intellectual Property Code of the Philippines (1997). It can be concluded that in the Philippines, biosafety regulation and intellectual property management systems have been effective in regulating the use of biotechnology materials and in providing IRP protection. The Philippine Biosafety Regulation System can adequately cope with biosafety regulation requirements at the current level of agricultural biotechnology research and development in the country.
Site Characteristics: In the Philippines, modern biotechnology R&D started in the late 1970s. In anticipation of the need to set-up an institutional and policy framework to govern the use of genetically engineered crops, a group of scientists from the University of the Philippines Los Baños (UPLB) and the International Rice Research Institute (IRRI) drafted biosafety rules. This became the basis of Executive Order (EO) No. 430 issued in 1990, which in turn, created the National Committee on Biosafety of the Philippines (NCBP) and instituted the Philippine Biosafety Guidelines (PBG). Other related measures such as Department of Agriculture (DA) Administrative Order (AO) No. 8 of 2002 (Implementing Rules and Regulations for the Import and Release into the Environment of Plant and Plant Products Derived from the Use of Modern Biotechnology); the Republic Act (RA) 9168 of 2002 (The Philippine Plant Variety Protection Act (PVPA) of 2002); the DA AO No. 7 (Implementing Rules and Regulations of the Philippine Plant Variety Protection Act, 2002), 2 and RA 8293 of 1997 (Intellectual Property Code of the Philippines) were issued to enhance the Philippines' capacity to comply with international agreements such as the Cartagena Protocol on Biosafety (2002) and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) (1994). However, while PBG mechanisms have been set-up, apparent gaps in the regulatory system have been observed.
Comments: Primary and secondary data were used in this study. Primary data was gathered through interviews with key informants (KIs) from state colleges and universities (SCUs), public R&D institutions, funding agencies, provincial and municipal agricultural offices, Institutional Biosafety Committees (IBCs), private seed companies, regulatory agencies, non-government organizations (NGOs) and farmers. Secondary data was gathered through the review of reports, policy papers, other relevant documents and biosafety guidelines from the various websites of international development organizations involved in biotechnology and biosafety (such as the Biosafety Information Network and Advisory Service-United Nations Industrial Development Organization (BINAS-UNIDO), Food and Agriculture Organization-Asian Biotechnology Network (FAO-Asia Bio-net), World Intellectual Property Organization (WIPO), National Academy of Agricultural Sciences (NAAS)-India, International Service for National Agricultural Research (ISNAR), Berekely Electronic Press (BEPRESS), and the Council for Biotechnology Information, DA, NCBP).