Chapter 10 Legal, Ethical and Social Concerns in Biotechnology Article XIV 1987 Constitution * Sec.10- S&T are essential for national development and progress. The state shall give priority to research and development, invention, innovation, and their utilization, NCBP * Undertake the study and evaluation of existing laws, policies and guidelines on biotechnology and its related matters * Recommend such measures for its effective utilization and prevention of possible pernicious effects in the environment. * Coverage :work involving genetic engineering A. Biotechnology Regulations: Philippine Policies Article Il of the 1987 RP Constitution * Section 15- Protection and promotion of right to health + Section 16- Protection and advancement of right of people to a balanced and healthful ecology in accord with the rhythm and harmony of nature * Section 17- priority to education, science and technology. National Policy on Biotechnology The state shall promote the safe and responsible use of modern biotechnology and its products as one of the several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment and industry development. * Identify and evaluate potential hazards involved in initiating genetic engineering experiments or the introduction of new species and genetically engineered organisms. = Recommend measures to minimize risksBiosafety Policy * Shall not engage in any activity related to chemical * Environmental Safety: containment policy and biological warfare. appropriate for the bichazard level of the organism + Guidelines shall apply to all research, production and used, manufacturing work and/or institutions in the * Product safety: adherence to country, whether public or private, national or a. Good Laboratory Practice(GLP) international, engaged in genetic engineering work. b, Good Manufacturing Practice(GMP) ©. Toxicity and potential adverse effects the therapy shedding of viral vector used. " Use of selectable markers in production of GMO's "Effects of Horizontal gene transfer to be considered with the features of selectable markers to be considered in assessing their hazards. a, Toxicity of the gene used as marker, 2. Spread of genes from a plant to microorganisms through non-sexual processes b. residues of genetically modified crops are b. Toxicity of the gene product. potential source of genetic pollution which may lead . Transfer of the marker gene to pathogens in the to antibiotic resistance in pathogens or environment. microorganisms. d. Potential damage to the environment due to the marker gene. Definition of Hazard, Risk, Harm and Damage in Biotechnology c. estimated contribution due to GM crops is 5.4.x * Hazard: “ a characteristic that in particular 110-6, which is comparable to the natural frequency circumstances can lead to harm. of mutation. + Risk: “ the chance in quantitative terms of harm, 4d, Breakdown products occurring from a defined hazard and the expression e. Non-specific Catalytic Activity “risk of (a specific event of set of events)” must refer Crop management to the hazard.* Harm: “occurs when a hazard is realized and damage is done to a human being (or other organisms or to the environment) + Damage: “loss of inherent quality suffered by an entity (physical or biological] Executive Order No. 247 (1995): Prescribing Guidelines and Establishing @ Regulatory Network for the Prospecting Of biological and Genetic Resources, Their By-products and Derivatives, For Scientific and Commercial Purposes * Provides for and Academic Research Agreements + Prior Informed consent of indigenous cultural communities if prospecting biological and genetic resources within their ancestral lands and domains * Prior informed consent of concerned local communities Original Composition of NCBP Chairperson: DOST Undersecretary for R&D Members: 1 biological scientist 1 physical scientist 2 respected members of the community ‘representative each from the DA,DENR, and DOH tobe designed by the respective heads of offices. environmental scientist 1 social scientist It shall be the policy of the State to regulate the prospecting of biological and genetic resources so that these resources are protected and conserved are developed and put to the sustainable use and benefit of the national interest. Provides for Commercial Research Agreements + There must be a limit on samples that may be obtained and exported *+ Complete set of all specimens collected shall be deposited with the National Museum or other government entity + Access to collected specimens and relevant data deposited abroad shall be allowed to all Filipino citizens and Philippine governmental entities.