• Enhance the decision-making system on the application of products of modern biotechnology
• Serve as guidelines for implementing international obligations on biosafety
EO, executive order.
The policies and issuances scoped cover 27 regulatory subjects, which include health products, facilities, animals, plants, and drugs, among others. Issuances covering each regulatory subject were analyzed according to the nine categories for developing sustainable capacity for biosafety and biosecurity in low-resource countries ( Table 3 ). 22
Summary of policies and regulatory subjects covered according to nine categories for developing sustainable capacity for biosafety and biosecurity in low-resource countries
Entity | Country- or region-specific regulatory framework and guidelines or standards | Biosafety and biosecurity awareness | Infrastructure | Equipment, reagents, and services | Management processes and administrative controls | Training | Biosafety curricula | Biosafety association, professional competency, and credentialing | Individual mentoring and organizational twinning |
---|---|---|---|---|---|---|---|---|---|
All health products | ✓ | ✓ | |||||||
Animal facilities | ✓ | ✓ | |||||||
Animal transport | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Animals | ✓ | ✓ | ✓ | ✓ | |||||
Biosafety policies, measures, guidelines | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Clinical laboratory | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Disease outbreaks | ✓ | ✓ | ✓ | ||||||
Foreign rendering plants | ✓ | ||||||||
Genetically modified plant and plant products | ✓ | ✓ | |||||||
GMOs | ✓ | ✓ | ✓ | ||||||
HIV testing laboratory | ✓ | ✓ | ✓ | ||||||
Human stem cell and cell-based or cellular therapy facility | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Indigenous, exotic, and genetically modified arthropods | ✓ | ||||||||
Inspection, testing and certifying bodies, and other bodies offering conformity assessment services | ✓ | ✓ | ✓ | ✓ | |||||
Medical devices | ✓ | ✓ | |||||||
Nonindigenous or exotic organisms | ✓ | ✓ | ✓ | ✓ | |||||
Quarantine | ✓ | ✓ | ✓ | ✓ | |||||
Specimens for confirmation testing of HFMD | ✓ | ||||||||
Specimens for EVD testing | ✓ | ✓ | ✓ | ||||||
Specimens for Leptospira spp | |||||||||
Specimens for MERS-COV and novel influenza viruses | ✓ | ✓ | |||||||
Specimens for TB testing | ✓ | ✓ | |||||||
Tissue culture laboratories | ✓ | ✓ | ✓ | ||||||
Veterinary clinics and hospitals | ✓ | ✓ | ✓ | ||||||
Veterinary diagnostic laboratories | ✓ | ✓ | |||||||
Veterinary drugs, products, biologics, medicinal preparation, and their establishments and outlets | ✓ | ✓ | ✓ | ||||||
Weapons | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Total | 17 | 3 | 16 | 16 | 19 | 8 | 0 | 0 | 0 |
Heckert et al. 22
EVD, Ebola virus disease; GMOs, genetically modified organisms; HFMD, hand, foot, and mouth disease; MERS-COV, Middle East respiratory syndrome coronavirus; TB, tuberculosis.
Seventeen of the 27 entities follow a specific regulatory framework, guideline, or standard. These are determined by a government agency, a committee or board, or follow existing international guidelines. The frameworks are usually concerned with regulation of an entity and include establishment of standards, practices, and monitoring and evaluation plan.
Three out of the 27 entities have policies that discuss awareness. It includes mandates on biosafety promotion, participation, and development of advocacy materials and risk communication plans. It also states the need for policymakers to be aware and provided with sufficient and current information on biosafety.
Sixteen of 27 entities have policies related to infrastructure. The level of detail provided in the guidelines for infrastructure varies between entities. Some entities, such as animal facilities and clinical laboratories, are provided with broad guidelines. Conversely, guidelines for GMOs provide detailed information for physical containment according to four biosafety levels.
Nineteen of the 27 entities are provided with governance mechanisms through a policy. A government agency, a network of agencies, or a committee created through an issuance oversees the implementation of a policy framework, guidelines, or standards. These policies also outline the responsibilities of municipal, city, and regional counterparts of national offices, when applicable.
Eight of 27 entities are provided with training guidelines in their handling, transport, and use for staff. The policies outline capacity-building programs, continuing education programs, and minimum training and skill requirements for staff.
No mandates were found for the following categories: biosafety curricula; biosafety association, professional competency, and credentialing; and individual mentoring and organizational twinning.
A total of 28 stakeholders were identified by the participants. Twenty-two of the 28 identified stakeholders were government institutions. Six stakeholders identified include academic institutions, training centers, associations, and civil society organizations. Identified stakeholders were further analyzed according to ideal roles, basis for ideal role, resources available and adequacy, and reaction to framework.
Ideal roles identified by the participants closely follow current functions that the various stakeholders already perform. Most roles are concerned with the integration or strengthening of existing rules and regulations for biosafety and biosecurity. Twenty-four out of 28 stakeholders have a legal mandate as basis for the roles identified to them by the participants ( Table 4 ).
Ideal roles of identified stakeholders
Ideal roles | Agency involved |
---|---|
Accrediting and auditing body for laboratories | Department of Trade and Industry |
Background checks and vetting of laboratory workers | Intelligence agencies |
• Calibration of laboratory equipment • Management of financial resources | Department of Science and Technology |
Conduct of investigation on alleged bioterrorists | Department of the Interior and Local Government |
• Creation of a National Emergency Response Team • Issuance of permits for packaging and transport of biologicals • Maintenance of BMC list | Department of Health |
• Creation of national action plan • Emergency response beyond control of the institution | • Anti-Terrorism Council • Armed Forces of the Philippines • Department of National Defense • National Disaster Risk Reduction and Management Council • Office of Civil Defense • Philippine National Police |
• Emergency response in disease outbreak in plants and animals • Human and animal surveillance • Issuance of guidelines and license to operate for clinical laboratories for animal specimen | Department of Agriculture |
Integration of biorisk management in curriculum and laboratory activities | • Commission on Higher Education • Department of Education |
Regulation of entry and exit of BMCs | • Bureau of Customs • Bureau of Immigration |
Regulation of transport of BMCs/infectious substances by land, water, and air | Department of Transportation |
BMC, biological materials of concern.
Commonly identified resources available to the stakeholders were legislation, funding, capacity building, manpower, and facility/technology/machinery ( Table 5 ).
Resources available and adequacy of identified resources
Adequacy | Agency |
---|---|
Adequate | • Anti-Terrorism Council • Armed Forces of the Philippines • Department of National Defense • National Economic Development Authority, • Office of Civil Defense • Philippine National Police |
Current legislation does not include biorisk | Commission on Higher Education |
Insufficient manpower | • Civil Service Commission • Commission on Higher Education • Department of Agriculture • Department of Education • Department of Environment and Natural Resources • Department of Labor and Employment • National Training Center for Biosafety and Biosecurity |
Lacking regional counterparts | Department of Agriculture |
Limited capacity building efforts | Department of Agriculture |
Limited experts on biosafety | • Commission on Higher Education • Department of the Interior and Local Government |
Limited funding | • Civil Service Commission • Department of Education • Department of Labor and Employment • National Training Center for Biosafety and Biosecurity |
Limited in general | • University of the Philippines-National Institutes of Health • Private sector |
Meets minimum requirements | • Bureau of Fire Protection • Data Privacy Commission • Department of Foreign Affairs • Department of Health • Department of Science and Technology • Department of Transportation • Intelligence agencies • National Disaster Risk Reduction and Management Council • Professional Regulation Commission |
Varies | • Civil society organizations • International partners • Local Government Units • Nongovernment organization |
Participants strongly linked receptiveness with the ideal roles identified to the stakeholders. Stakeholders who are currently performing their ideal roles or have the resources to perform them were perceived to be more receptive. Stakeholders with unfamiliar functions or mandates to participants were less likely to be perceived as receptive ( Table 6 ).
Possible reaction to inclusion in framework
Possible reaction | Stakeholder |
---|---|
Receptive | • Anti-Terrorism Council • Armed Forces of the Philippines • Civil Service Commission • Civil society organizations • Data Privacy Commission, • Department of Budget and Management • Department of Environment and Natural Resources • Department of Health • Department of Labor and Employment • Department of National Defense • Intelligence agencies • International partners • National Disaster Risk Reduction and Management Council • National Training Center for Biosafety and Biosecurity • Nongovernment organization • Office of Civil Defense • Philippine National Police • Private sector • University of the Philippines-National Institutes of Health |
Receptive with reservations | Department of Agriculture |
Initially argumentative to eventually receptive | • Commission on Higher Education • Department of Education • Private hospital associations |
Neutral | • Department of Science and Technology • Department of Foreign Affairs |
Varies/mixed reactions | • Department of Interior and Local Government • Department of Transportations • Hospital/laboratory owners • Local government units |
Not sure/no consensus reached/no reaction identified | • Bureau of Customs • Bureau of Fire Protection • Bureau of Immigration • Department of Trade and Industry • National Economic Development Authority • Professional Regulation Commission |
A total of 114 votes were cast by 38 participants ( Table 7 ). The top three desired policy outcomes were (1) capacitating existing facilities to comply with the proposed policy, (2) professionalization of biosafety officer/creation of plantilla (a government-approved regular position), and (3) enhancing quality of laboratories.
Policy outcome activity results
Policy outcome | Pros | Cons | Votes | % |
---|---|---|---|---|
Capacitating existing facilities to comply with the proposed policy | • Compliance improves quality • Employee retention • Opportunities for ABOT graduates to be subject matter experts | • Acceptability • Burden, timeline, manpower • Responsibility | 29 | 25.44 |
Professionalization of biosafety officer/creation of plantilla | • Authority, recognition • Capacity building • Career opportunity • Local monitoring entity • Self-reliance | • Greater responsibility • Increase in qualification • No CPD units • Overlap of function | 27 | 23.68 |
Enhancing the quality/outputs of laboratories | • General safety, client satisfaction • Income • Integrity • Reproducible outputs • Satisfied employees | • Accountability • Budget, timeline • Extra work • Manpower, sustainability | 20 | 17.54 |
Penalize erring laboratories | • Income • Prompt corrective measure • Quality/accreditation • Strict compliance | • Cheating • Corruption • Fines • Possible shut down | 10 | 8.77 |
Specialized unit for biorisk management | • Chance to become a certifying body • Ensures biorisk management is not neglected | • Budget • Manpower • Space | 9 | 7.89 |
Creation/regulation of Institutional Biosafety Committee | • Monitoring • Prestige • Safe research • Speed of processing • Strict compliance | • Authority • Budget • Conflict • Lack of expertise | 8 | 7.02 |
Trained personnel | • Compliance improves quality • Employee retention • Opportunities for advanced biosafety officer training graduates to be subject matter experts | • Acceptability • Burden, timeline, manpower • Insider threat • Responsibility | 5 | 4.39 |
Controlling the number of new laboratories | • Easier management • Less competition • More efficient use of research quality • Traceability and monitoring | • Failure to meet needs • Increased risk during transport • Less accessibility to public • Monopoly • Worker fatigue | 3 | 2.63 |
Positive reinforcement | • Employee retention/promotion • Income • Motivation • Prestige | • Academic dishonesty • Budget • Commercialization | 3 | 2.63 |
ABOT, Advanced Biosafety Officer Training; CPD, Continuing Professional Development.
The desired policy outcomes were concerned with improving responsiveness and equity of facilities. This is manifested in the identified pros and cons of the outcomes. Pros include improved quality, increased client satisfaction, conduct of safe research, and increased employee satisfaction and retention. Cons identified include lack of budget, unrealistic timelines, lack of accountability, decreased access to facilities due to shutdowns, worker fatigue, and lack of manpower.
Based on the discussions, current response mechanisms are initiated with (1) an investigation and preparation of a case report by the lead veterinarian, (2) handling and transport of samples to the designated Regional Animal Disease Diagnostic Laboratory, (3) coordination between animal and human health response, (4) activation of reporting mechanisms to the local government unit and other concerned agencies, (5) monitoring and surveillance of other farms in surrounding areas, (6) quarantine efforts, (7) interagency coordination at the local level, (8) channeling of information from local to national actors, and (9) media and press relations.
Across the existing response mechanisms already mentioned above, the following common gaps were revealed ( Table 8 ): weak implementation or noncompliance to existing standards and protocols, unclear coordination mechanisms for emergency response, lack of training and education, and limitations in human resources and infrastructure.
Gap analysis results
Response phase | Gaps identified | |
---|---|---|
Event 1: Dead piglet brought to the RADDL for testing | Subevent 1.1: Initial laboratory testing for suspected ASF | • Weak implementation of existing SOPs and policies • Lack of quality assurance of skills and training of veterinarians and laboratory staff on proper knowledge and practices in animal testing • The need to regulate laboratory practices among government and private facilities through strict monitoring and evaluation processes • The need to ensure availability of controls in the laboratory, in relation to the validity of testing • The need to strengthen HR capacity for 24/7 emergency staff response • The need for guidelines and reliable reporting mechanisms to RADDL through the adoption of possible strategies such as an electronic geographic information systems-enabled reporting mechanism • Lack of protocols for waste disposal |
Subevent 1.2: Samples negative for ASF and stored in refrigerator for next day | ||
Subevent 1.3: 36 pigs dead not reported to RADDL during weekend | ||
Subevent 1.4: Dead pigs of two more farmers brought in for testing | ||
Subevent 1.5: 6 farms affected with high pig mortality | ||
Activation phase | ||
Event 2: Samples brought to another laboratory for testing 250 km away | Subevent 2.1: Meat of dead pigs sold in the market | • Noncompliance to SOPs for the handling, transport, and referral of samples in larger distances to reference laboratories • The need for coordinated action among different government agencies • The need for clear coordinating mechanisms between animal and human health responders • Shortage of personal protective equipment for responders • Incorporating proper documentation as part of laboratory SOPs; recording and tracking system should be in place • There is a need for retraining and re-educating laboratory personnel on safety practices |
Subevent 2.2: Children getting sick | ||
Subevent 2.3: Analyst getting sick and not reporting in; samples missing from laboratory | ||
Subevent 2.4: 17 affected farms, pig mortality >50% | ||
Coordination phase | ||
Event 3: Confirmed diagnosis | Subevent 3.1: Local media asking for update | • There is a need to ensure compliance to laboratory SOPs on divulging information to media • There is an absence of facility for burying of carcass and waste decontamination and disposal • Implementation of policy to monitor laboratory personnel, as part of safety and security precaution |
Subevent 3.2: Samples from vet reference laboratory positive for ASF | ||
Subevent 3.3: Pig carcasses buried on-site | ||
Subevent 3.4: Visit to analyst's home reveal samples used in “DIY home experiments” |
HR, human resource; SOPs, standard operating protocols.
Discussions in the three CWG meetings resulted to feedback on (1) framework design and (2) political strategy. Key recommendations are described hereunder.
Early drafts of the framework incorporated the establishment of the Biorisk Management Coordinating Agency, but the CWG advised against putting up a new agency, as it creates more bureaucratic processes. Instead, clarifying roles, capacitating existing institutions, and harmonizing existing efforts were recommended.
The design must be based on functions that need to be fulfilled in terms of biosafety and biosecurity, adopting a bottom-up approach, and incorporating inputs from frontline actors. These functions form the key areas of the framework in its current form.
Early drafts of the framework lacked proper emphasis on disaster risk reduction and management. The CWG advised the incorporation of the four pillars of disaster risk reduction and management, namely prevention and mitigation, preparedness, response, and rehabilitation and recovery, as the key contexts of the framework in its current form.
As the secretariat of the National Disaster Risk Reduction and Management Council, the Office of Civil Defense has the power to direct various agencies when facing a threat. Thus, it was discussed as strategic to house biosafety and biosecurity functions under this office.
The framework may be passed into law through a senate bill, house bill, or an EO signed by the president. It was agreed upon by the CWG that an EO would be the most strategic pursuit for this policy.
There is a possibility that the bill may be passed into law, but not funded and thus, not properly implemented. The CWG emphasized the importance of stating clear funding mechanisms in the document.
Based on these results of the Phase 1 assessment and recommendations of the CWG, a National Biorisk Management Framework was formulated ( Figure 2 ). The proposed framework is composed of eight key areas in biosafety and biosecurity and four key contexts in risk reduction and management.
Proposed National Biorisk Management Framework.
In an increasingly connected world, emerging or re-emerging diseases and the deliberate or undeliberate release of infectious agents hold greater potential to affect populations across borders. 29 Global experience with SARS (2003), H1N1 (2009), and COVID-19 (2019) shows that pandemics have extensive health, social, and economic impact that has made the importance of biosafety and biosecurity preparedness more evident. 30–34 Advances in biotechnology has also leaped the application of biological sciences in the fields of health, agriculture, and environment, among others. However, this advancement comes with an increased risk for DURCs. 35 , 36 Although there are obvious benefits to biological research, the increased DURC risk has created a moral and ethical dilemma for the life sciences: do the benefits of the research outweigh the risks? 37 Creating a biosafety and biosecurity framework, therefore, presents the challenge of striking a balance between protecting public health while creating a sound regulatory environment necessary for research and innovation. 32 , 38
The current Philippine National Biosafety Framework, EO 514, was part of a UN Environment Programme-Global Environment Facility initiative to assist countries in developing a national framework after the ratification of the Cartagena Protocol on Biosafety. The Philippines EO 514 definition of biosafety suggests that biosafety policies may apply to multiple sectors related to biosafety. However, the scope of the framework is limited to products of modern biotechnology, exotic species, and invasive alien species, leaning heavily toward the agriculture and environment sector.
This concern was also raised by participants during the stakeholder analysis. First, established policies that have already defined “biosafety” may mean that a different terminology should be used in the framework being proposed that encompasses all activities related to biosafety, extending to public health, laboratory management, and outbreak response. Second, the current definition in EO 514 focuses on the potential harm of regulated articles. However, there is a growing recognition that access to information, processes, practices, and equipment is equally important as having access to a biological or hazardous material. 39 An expanded concept may be necessary that balances the perspectives of science, security, prevention, and preparedness beyond laboratory work. 15
Consistent with the definitional limitation, the current policy framework lacks emphasis on risk reduction and management functions in response to the rise of complex biological threats, regardless of the cause. The integration of biosafety and biosecurity efforts to prepare for and respond to these threats should be found at the heart of biorisk management, broadly defined as the assessment of risks, identification of measures to reduce risks, and development of processes to implement and review risk-reduction measures. 40 Although existing regulatory processes already form a significant part of risk prevention and mitigation, there should be improvement in how these functions tie up alongside other efforts in the country's overall disaster risk reduction and management framework, particularly in risk preparedness, response, rehabilitation, and recovery.
The debate on whether regulation impedes innovation persists today as new technologies, particularly in the field of biological sciences, generate calls for application of the precautionary principle. 41 The precautionary principle is an approach to innovations with potential for causing harm when extensive scientific knowledge is lacking. 42 The relationship between regulation and innovation is complex and different regulatory instruments have varying effects on technological progress. 41 Although international legal frameworks for biosafety and biosecurity exist, these provide limited guidance on what constitutes a functional national regulatory framework. It is the responsibility of national governments to produce and implement evidence-based policies that apply the precautionary principle emphasized by the Cartagena Protocol on Biosafety. 36
Spearheaded by the National Committee on Biosafety of the Philippines, the implementation of policies related to biosafety is a task shared by four government agencies. The Department of Agriculture, Department of Environment and Natural Resources, Department of Health, and Department of Science and Technology have multifaceted roles that involve biosafety and biosecurity policy development, accountability, and capacity building. This current system utilizes a combination of network and traditional command and control regulation. These agencies regulate overall biosafety activities in the country while also being the sole regulatory arm of entities under their mandate.
Results of our policy review shows that the four agencies have developed policies to regulate biosafety through enforcing guidelines and standards ( Table 2 ). Although these policies have been implemented, stakeholder analysis results show limited capacity of regulators to maintain this ( Table 5 ). Insufficient institutional capacity manifests in the limited training of regulatory personnel and variations in the level of detail between and within biosafety policies of different agencies. Current policies in training refer to continuing education for facility workers in relation to biosafety but do not include regulatory personnel. This is consistent with stakeholder analysis findings, wherein participants noted that some agencies should but do not currently have the technical expertise to develop or implement policies on biosafety and biosecurity.
The lack of consensus for some agencies also shows the need to determine their structure, current competencies, and how regulators are regulated. In appointing a regulator, there should be consideration that the regulator should be as informed as the regulatees. The question of “Who regulates the regulators?” must examine which external bodies or individuals have the authority to reconsider the decisions made by the regulators. 43
Responsive regulation maintains that regulators are more likely to succeed by using mechanisms that are responsive to the context, conduct, and culture of those being regulated. 44 A command and control approach, as is currently applied in the Philippines, is an appropriate form of regulation when all parties agree to minimum standards of quality. 45 However, there is currently little involvement of the general public in regulatory functions. The Philippine National Biosafety Framework limits public participation to information related to biosafety decisions and begins only from the time an application is received. There is still a need for collaboration in disseminating regulatory standards and establishing the state's authority as a regulatory body.
The gap analysis shows that at the local level, there are existing scenario-based protocols at each phase of the emergency response to potential disease outbreaks, but harmonization is lacking. Based on the findings of the tabletop exercise, efforts in the implementation of protocols in laboratory testing and operations; monitoring and surveillance; quarantine response; veterinary and clinical disease investigation; waste disposal and decontamination, media, and; law enforcement are concrete but uncoordinated.
In an ideal setting, these mechanisms are implemented by local responders from the Bureau of Fire Protection and Philippine National Police. However, clear coordination mechanisms required to bridge the gap between public health and national security are either lacking or slow in activation. To set up a robust response strategy, multidisciplinary networks with diagnostic capabilities in law enforcement and public health, including environmental, agricultural, food, veterinary, and clinical institutions, are necessary to handle both intentional and unintentional biorisk incidents. 46
A common framework for biosafety and biosecurity must be created to accurately assess the risks posed by biological threats and ensure understanding of multidisciplinary strategies needed to mitigate them. This can be achieved by considering four key points 40 : (1) difficulty in estimating likelihood and consequences of a biological threat, (2) the need for broad and comprehensive definitions of biosafety and biosecurity to bridge the gap between national security, life sciences, and public health communities, (3) inaccurate perception of risk and its implications in the response, and (4) synergy in research and formulation of policy.
Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms for multidisciplinary and multilevel communication and interaction toward harmonized risk reduction and management; (2) establishes, benchmarks, develops, implements, and enforces guidelines on biosafety, biosecurity, and biorisk management; (3) regulate facilities where implementation of such guidelines is considered essential for occupational safety and the health of the public; and (4) is financed by the General Appropriations Act as part of the national budget.
The COVID-19 pandemic has manifested the gaps identified in this study. Policies and support mechanisms that focus on workforce development, particularly on trainings and workshops, provide a low-investment but high-impact solution in reaching the reform goals. An effective training program provides a cost-efficient longer term solution for lower to middle-income economies as heavy reliance on infrastructure and engineering safeguards involves overhead costs being accrued over time, impeding local acceptance and sustainability. Awareness-level trainings to policymakers also provide a common language among stakeholders and start an avenue for collaborative discussions. These introductory trainings allow engaging champions from various sectors, increasing the likelihood of program sustainability and accelerating simultaneous capacity building among stakeholders. The multidisciplinary approach enables collaboration and linkage among agencies and other concerned entities to prepare for and respond to a biological event of any scale in a timely and consistent manner.
No competing financial interests exist.
This study was funded by the University of the Philippines-National Institutes of Health and the U.S. Defense Threat Reduction Agency-Biological Threat Reduction Program.
Philippine biosafety regulatory gaps and initiatives.
The Philippine Biosafety Regulations started out strong in biotechnology and leads the Southeast Asian Region. However, regulatory issues and concerns surfaced that slowed down the progress of the country. Initiatives are currently being done to answer and bridge the gaps. There is a need to establish a liability and redress mechanism to address potential damage from genetically modified organisms (GMOs). However, ratification to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress is yet to be considered as the Philippines still lacks the capacity to implement such the Supplementary Protocol. The proposed change in language of the inclusion of socio-economic considerations (SECs) from “shall take into account” into “may take into account” aligns the regulation with the language in the Cartagena Protocol on Biosafety, while also limiting the possibility of politicization which is experienced in countries with regulation shaped by SECs. Finally, the emergence of New Breeding Techniques allowed the regulation to be product-based, as compared to the previous process-based regulation of genetic engineering products. Further steps in regulatory reform should then be sensitive to scientific development, while also aiming for international regulatory harmonization. The initiatives will be important as the Philippines prepare for future biotechnology developments.
Keywords: liability and redress, socio-economic considerations (SECs), New Breeding Techniques (NBTs)
INTRODUCTION
The development of biosafety guidelines was prompted by the discovery and use of recombinant DNA (rDNA) technology in biotechnology research in the early 1970s in recognition of their potential hazards to the human health and the environment. The first set of biosafety guidelines was crafted and used for self-regulation of rDNA biotechnology researches at the University of the Philippines Los Baños (UPLB) and the International Rice Research Institute (IRRI). As the use of rDNA biotech spreads to the national research network, the scientists prepared a proposal to establish the National Committee on Biosafety of the Philippines (NCBP) in 1990 through Executive Order 430. The NCBP formulated and published the Philippine Biosafety Guidelines Series 1 in 1991. Since then, NCBP has been serving as the national authority as regards the development of biosafety policies and guidelines in coordination with the concerned agencies and department, for activities involving modern biotechnology and genetically modified organisms (GMOs) (NAST, 2009). The Philippines has also ratified the Cartagena Protocol on Biosafety (CPB), which requires the regulation of GMOs before they are subject to transboundary movements.
A science-based regulation permitted the Philippines to be the first in Asia to have a GM crop commercialized in 2002—the Bt Corn. By 2006, the spread of cultivation enabled the country to join the ranks of biotech mega-countries (growing at least 50,000 hectares as reported by ISAAA 2016). To this date, the Philippines leads in Southeast Asia in GM crop cultivation. While the country had a strong start in GM research and production, progress has been evidently slower during the last decade especially with the shift in the biosafety policy from the Department of Agriculture Administrative Order no. 8 (DA-AO8) to the Joint Department Circular no. 1 (JDC-1) in 2016. This was the aftermath of a dispute over Bt Eggplant wherein local and internationally backed anti-GMO groups vandalized the field trials. The gap year in 2015 while the AO8 was under review suspended all ongoing and approved applications and forced them to resubmit under the new system of the JDC-1 (USDA-FAS 2020). Constraints in the regulatory process delayed the development of Bt Eggplant despite being on the brink of commercialization. As the national governments were busy with reforming DA-AO8 and crafting JDC-1, such has actually diverted their attention from other pressing issues such as the potential damage from GMOs, new breeding techniques, and socio-economic considerations.
The Cartagena Protocol opened the negotiations for establishing a legally binding international instrument for liability and redress, addressing potential damage from the transboundary movement of GMOs. However, the Philippines has not made any move on the international instrument, even if the country is one of the negotiators. Considering that damage may arise from the use of counterfeit seeds, which can be described as the unauthorized production and sale of GM corn seeds, there might be a need to consider ratifying the international instrument.
Another concern is whether the products of New Breeding Techniques (NBTs) will be subject to regulation. NBTs are emerging technologies with wide applications in agricultural research, and the existing regulatory systems (not just in the Philippines but also in many other countries). Through SDN1 and SDN2 of NBTs, it is possible to develop genetically edited plant varieties that do not possess a foreign gene. By virtue of the absence of a foreign gene, scientists argue that such products are equivalent to conventionally developed varieties although the process falls under genetic engineering. However, the definition for GM and regulated articles are process-based and therefore guidelines have to be revised.
Lastly, the commitment of the Philippines to the Cartagena Protocol prompted JDC-1 to include socio-economic considerations (SEC); this too needs to be revisited. While SECs include the social, ethical, and economic concerns that can potentially cover the broader risks posed by the GM product, the question remains on whether SECs should be a mandatory requirement.
This paper discusses the above regulatory issues and concerns that need to be addressed by the Philippine regulatory system. There are already some initiatives being undertaken, and options which the country can pursue in moving forward. The first section tackles the gap on mechanisms for liability and redress in addressing damage from LMOs. The second section discusses the emergence of NBTs and how this fits with the regulatory system. Finally, the last section looks at the implications of including/excluding socio-economic considerations.
GAP ON LIABILITY AND REDRESS
The Nagoya-Kuala Lumpur Supplementary Protocol
Article 27 in the Cartagena Protocol provided the opportunity for countries to establish laws and procedures addressing damage arising from the transboundary movement of GMOs, materializing into the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The Supplementary Protocol puts persons (termed as operators) liable or responsible for damage caused by GMOs, ensuring they will undertake measures that will redress/remedy the damage (CropLife International, 2013). To be considered as damage, the conservation and sustainable use of biological diversity, or human health should be affected first, characterized by an adverse, measurable and significant effect (Nijar, 2012). There are two pathways to deal with the damage. First, in the administrative approach, a national authority has the power to identify and require the operator to take measures for the damage, or even implement response measures itself. Second, the civil liability approach defers to the domestic laws to settle the damage. The Nagoya-KL Supplementary Protocol has been open for signature and ratification since 2010 and as of October 2020, there are already 48 countries ratified to the Supplementary Protocol. However, the Philippines has not made a move to sign the Supplementary Protocol. As the Philippines continue to deal with GMOs, it may be worthwhile to consider having a liability and redress mechanism, but the limitations in adopting such mechanism should be also understood first. The next few sections weighs in on the factors at stake for the Philippines in ratifying the Supplementary Protocol.
Benefits of the Supplementary Protocol
With an established mechanism for liability and redress, it may promote an enabling environment for maximizing the benefit from GMOs. The mechanism will serve as fall back in the event of damage. In particular, countries with insufficient resources and are biological diversity hotspots will have more incentives to establish a liability regime (Santoso 2016). The Supplementary Protocol may also help implement the polluter who pays principle, where the cost of damage repair is shifted on the person liable and not on the society (Santoso et al., 2018). While that principle is already applied with regards to environmental damage, the Supplementary Protocol makes it relevant in the context of GMOs (de Guzman, 2001). Furthermore, many provisions, especially the article on civil liability procedures, defer to the domestic law which imposes a sense of flexibility on the countries. After all, the instrument was made a Supplementary Protocol instead of an amendment to the CPB to allow countries to assess whether ratification would align with their national priorities and interests, and to decide their own procedures for pursuing response measures (Jungcurt and Schabus, 2010). This provides room for the rules and procedures to fit in the context of the countries for easier implementation. The Supplementary Protocol may also provide an incentive to comply with environmental norms (Santoso et al,. 2018). The possibility of being liable to a damage and the burden for undertaking response measures may influence the operator to take more precautionary and preventive measures during its activities. In this sense, the extra caution to be exercised may generally lessen the possibility of damage occurrence.
Underlying issues of the Supplementary Protocol
There are challenges in the implementation of the Supplementary Protocol. First, the provisions are largely administrative in nature, owing to the lone article dedicated for the civil liability. Consequently, developing countries that are unfamiliar with the administrative approach may struggle in the implementation of the Supplementary Protocol. Second, substantial resources are needed to implement the Supplementary Protocol. During the negotiations, the financial guarantee is particularly a major point of discussion (Gupta and Orsini, 2017). This issue is particularly relevant when small operators become liable to large damage that is beyond their capacity to compensate. In the event that the operator fails to provide remedy, countries must be financially prepared to ensure that compensations or response measures will still happen. Financial resources are also needed in determining the occurrence of damage. For example, a baseline data is required in order to establish the occurrence of damage (Santoso et al.. 2018). Conducting the baselining activity, and even up to the monitoring and detection of damage, would require financial resources, and manpower as well.
The problem of counterfeit seeds
Damage can still occur through the use or movement of GMOs within the national boundary. However, the Nagoya-KL Supplementary Protocol was formulated to address only the potential damage coming from the transboundary movement of GMOs. Nevertheless, the principles and procedures in addressing damage provided in the Supplementary Protocol are still applicable to domestic damage. This can be the opportunity to establish a mechanism in addressing domestic damages, especially for countries already using GMOs without a formal liability regime. In the context of the Philippines, the issue of counterfeit seeds may be relevant in the discussions on the ratification to the Supplementary Protocol.
Counterfeit seeds contain the traits of a GM Corn that did not undergo the rigorous regulatory process, and are produced and sold by unauthorized people. Counterfeit seeds come in two forms: “ukay-ukay” seeds and “sige-sige” seeds. “Ukay-ukay” seeds are pilfered seeds from production areas, while “sige-sige” seeds are the offspring of the F1 GM seeds, consequently losing the vigor of the resistance trait (Aguiba, 2018). Counterfeit GM seeds are sold as conventional seeds, and thus, do not come with a refuge system as required for insect resistance management (IRM). The seed industry reported that the proliferation of counterfeit GM Corn seeds resulted in a decline of 18.6% in the adoption rate of GM corn in 2016 (Arcalas, 2018).
The inadequate implementation of the refuge system could encourage the evolution of the target pest resistance to the Bt toxin in GM corn, possibly compromising the effectivity of the GM technology and discouraging adoption by farmers (Bourguet et al., 2005). Superior pest populations may develop that will make pest management methods ineffective, and could adversely affect and damage biodiversity in the long run (Dhillon et al., 2011).
While there is no evidence yet to prove damage from counterfeit seeds, the potential of these seeds, and of GMOs in general, to cause damage should not be undermined. The need for a liability and redress mechanism is recognized, but necessary preparation in terms of financial resources and manpower is required to implement such mechanism. The Philippines may not be adequately equipped with the requirements for the implementation, considering that the country has not made a move on the Supplementary Protocol for several years. Nevertheless, the Philippines should still prepare for the possibility of ratification considering that there will be more engagement on biotechnology activities as indicated by the ongoing review of the existing regulatory system.
IMPLEMENTATION OF SOCIO-ECONOMIC CONSIDERATIONS
Legal basis of SECs
Regulatory oversight under the Cartagena Protocol largely focuses on the science-based risk assessment of GM products in relation to the human health and environment. However, Article 26 of the Cartagena Protocol also leaves the possibility for countries to include the broader concerns of the public during the assessment, such as socio-economic considerations (Falck-Zepeda, 2009). The Protocol did not formalize the procedures in implementing SECs, which leaves flexibility for countries. In response, several countries including the Philippines, Brazil, and Kenya have expressed their willingness to include SECs in their frameworks (Falck-Zepeda 2009). Nevertheless, compliance with including socio-economic considerations in the decision making has been controversial among countries, and still remains as a major point of contention up to now.
In the Philippines, SECs are reflected in the National Biosafety Framework (NBF) and JDC-1. The NBF required the issuing of guidelines for the conduct of socio-economic assessments, in which the effects on small farmers, indigenous people, and women among others will be accounted for. SECs are incorporated in the JDC-1 through the application process where a questionnaire regarding the potential socio-economic impacts of the product are answered and submitted. The SEC submissions are then evaluated by a biosafety committee, which may tap specially-appointed experts. However, proposals in the ongoing review of the JDC shifts the language of SEC inclusion from “shall take into account” into “may take into account” suggesting that SECs will now be optional and not mandatory. This aligns with the language provided in the CPB. Public consultations will be the avenue to account for SECs instead the application process.
Benefits and implications of SEC inclusion
Some countries like Norway, Mexico, Thailand, and Egypt have increasingly incorporated SECs into their frameworks, moving away from science-based assessments and towards the broader and less quantifiable issues such as the societal and ethical concerns (Smyth and Phillips, 2014). Arguments for supporting the inclusion of SECs point out their relevance in protecting the rural and indigenous communities and their livelihoods against the negative impacts of GMOs to (Falck-Zepeda, 2009). The discussion regarding SECs is particularly relevant in countries that are biodiversity hotspots (Catacora-Vargas, 2012). Furthermore, there is a recognition that responsibility for each technological intervention does not end in the confinement of laboratories, and that developers have a social responsibility to fulfill once their products enter the market (Catacora-Vargas, 2012).
Inclusion of SECs will have several implications in the regulation. First, they may complicate the current biosafety regulatory process, especially in the decision-making (Mampuys, 2018). Scenarios may occur where the product is determined to be safe during the biosafety assessment but fails during the socio-economic assessment. It begs the question of how SECs will weigh against scientific evidence in reaching a decision for approval of the product. Second, clear rules and procedures must be in place to establish a predictable regulatory system. The imparted certainty and robustness can boost the interest of developers and encourage them to invest more in product development.
Lastly, there is also a corresponding increase in the regulatory cost and delays for each assessment which vary depending on the scope of the study (Falck-Zepeda and Zambrano, 2011). More resources and specialized personnel will be required for conducting such assessments, in which countries with insufficient capacity will experience difficulties. Higher cost may force public institutions with less available resources to explore other non-regulated technologies, potentially reducing the number of technologies to be released for the public (Falck-Zepeda and Zambrano, 2011). While the added cost will have direct impacts, a study has shown that delays will even have more impact in decreasing net benefits compared with the cost (Bayer et al,. 2010).
Politicization of SECs
While there are perceived benefits for society, experience shows that the societal dimension may not be the only focus of the SECs. As socio-economic considerations take on a bigger role in the regulation, product assessments tend to be more subject to politicization. Decisions will then be impacted more by the pressure exerted by environmental non-government organizations (eNGOs) lobbying against GMOs (Smyth and Phillips, 2014). Experience from countries that shaped their regulatory system using SECs such as in the European Union and Norway demonstrate how the political dimension is exploited in decision-making. In the EU, politicization is apparent where the precautionary principle is used as an excuse by politicians for banning GMOs despite having science-based information on the safety of GMOs (Aerni 2019). In Norway, GM Corn was prohibited in the country because of the skepticisms expressed by the public, particularly from non-government organizations and farmer unions, even if the product did not represent negative effects on health (Myskja and Myhr, 2020). These examples demonstrate how political pressure can be decisive in the decision-making for GM approval with little regard to scientific evidence.
Looking forward
The potential benefits of the inclusion of SECs in the decision making are already recognized internationally and our country has already expressed its interest. However, partaking in such direction entails rigorous preparation in terms of the capacity to implement and incorporate such assessments in the regulation. The inclusion of SECs in regulation also makes decision-making prone to political pressure, even if the biosafety assessments prove the safety of the products. Considering the ongoing JDC-1 reform that shifts the implementation of SECs to optional, SECs will have a limited role in decision-making which reduces the possibility for politicization of the regulation, while also promoting a science-based regulation. The reform also helps shape a more manageable system considering that the Philippines already lacks the needed resources to conduct socio-economic assessments. In hindsight, the reform on SECs may prove advantageous to the Philippines as it engages deeper in biotechnology.
UNCERTAINTY AROUND NEW BREEDING TECHNIQUES
New plant breeding innovations
For many years, genetic engineering has been the premier molecular technique for plant breeding, which was also the basis for the establishment of regulation worldwide. However, science has come a long way as new and more sophisticated techniques based from the increased understanding of plant breeding has emerged in the past decade. The collection of these new techniques is termed as New Breeding Techniques.
NBTs shows promise as a tool for crop improvement by inducing genetic change not possible before. First, while genetic engineering allows the insertion of foreign DNA into cells, gene editing is capable of imparting genetic modification using the target organism’s own genome without having to transfer a whole gene from a different organism. Second, the highly precise nature of NBTs allow changes at specific sites in the genome with minimal unintended modifications, compared with the random, and consequently prone to off-site changes of genetic engineering techniques (Wolter et al,. 2019). Lastly, genetic engineering can only modify single traits, but NBTs allow simultaneous manipulation of multiple traits (Wolter et al,. 2019). The use of NBTs makes it advantageous to work with traits relevant to improving agricultural productivity such as disease resistance, insect resistance, and abiotic stress tolerance.
NBTs result to a large spectrum of products that fall between the products of genetic engineering and conventional breeding. Some techniques are only an improvement of conventional techniques (SDN1, SDN2), consequently inducing changes that are commonly found in nature or from techniques with a proven history of safe use (Sprink et al., 2016). Furthermore, those techniques result to final products without gene insertions, escaping the GM regulation (Araki and Ishii, 2015). Other techniques insert genes (SDN3) resulting to transgenic products or GMOs, qualifying for GM regulation. The heterogeneity of NBT products is the main challenge for regulation.
The problem of regulation
The existing GM regulation is process-based, where all products derived through genetic engineering are regulated, irrelevant of the characteristics of the final product. This is because the regulation was established in response to genetic engineering. Since similar products should be given the same level of regulatory oversight, it is logical that NBT products similar to their conventionally-bred counterparts should not trigger GM regulation (Conko et al,. 2016). However, the existing regulation does not distinguish these NBT products, and would instead classify them under the regulation. Therefore, the existing GM regulation is unfit for giving the NBT innovations commensurate regulatory oversight (Davison and Ammann, 2017). This posits the need to update the regulation into a product-based regulation.
The concept of a product-based regulation is aligned with the accumulated scientific development and experience in the past decades. Using the studies already conducted, the scientific community has reached a conclusion that the process used to produce an organism, whether it would be genetic engineering or any molecular tools, is unrelated to the level of risk of the resulting product (Conko et al., 2016). Therefore, in order to formulate a scientifically sound regulation, the product should be the primary consideration in deciding its regulation and not the process used to obtain the product (McHughen, 2016). Initiatives to address these NBTs through a product-based regulation have already started in the Philippines, which will be discussed in the next section.
Regulatory status of NBTs in the Philippines
In 2018, a team composed of Dr. Reynante L. Ordonio, Atty. Paz J. Benavidez II, Atty. Edmund Jason G. Baranda and Dr. Ruben L. Villareal was commissioned to review the research and regulatory landscape of NBTs and come up with a material that will help regulators formulate the appropriate framework. For the purpose of the study, the team set a criterion for determining regulation and consequently reviewed the known techniques as of 2018 whether they would give rise to products that will be regulated.
In the existing biosafety regulation, the articles produced using modern biotechnology and in possession of novel combinations of genetic materials will be subject to regulation, in which the term “novel combinations” is not defined. For the purpose of the study, the team came up with the definition as “those not likely formed in nature or not possible through conventional breeding” (Baranda et al., 2018). The proposal is well aligned with the scientifically-sound product-based regulation, as the regulation will only be triggered if the final products contain novel combinations.
In the same material, a fragment length threshold was also proposed where introduction of fragments shorter or equal to 19-base pairs (bp) can be considered as native sequences and thus would not be regulated, while sequences with at least 20-bp will trigger a review if the product falls under the regulation. However, in the update presented by Dr. Cariño last October 13, 2020 in the webinar “Regulation and Genome Edited Plants” organized by CGIAR, this rule was not mentioned in the current regulation update in the Philippines and might have been dropped. Nevertheless, the proposed definition for the novel combinations was retained. The updates to the Philippine regulation are expected to be released in the near future.
Rapid development in science for only a few years resulted to the current plethora of NBTs, and scientific progress is expected to be faster in the coming years. The emergence of NBTs exposed the problem that the existing legal framework has been outpaced and outdated by the scientific progress, causing a growing gap between innovation and regulation. Policy development will then be critical as it would influence the next generation of researches and innovations. This includes the technology transfer from the international scene into the country as well. Considering that local development alone would not support biotechnology development in the country, the Philippines should then work towards a more science-sensitive regulation, where the global scientific understanding on biotechnology is recognized and accommodated. This would encourage and permit knowledge-sharing, technology transfer, and trade of biotechnology innovations with other countries. Moving forward, as we continue to engage deeper in biotechnology, regulatory reforms should also be directed towards international harmonization.
There is an opportunity to address the pressing issues surrounding the GM regulation. Complying with the obligations on the Cartagena Protocol regarding liability and redress and SECs would require resources that the Philippines does not adequately have, which poses a challenge to their implementation. The country will have to delay its ratification to the Supplementary Protocol, but the need for a liability and redress mechanism should be considered in the future. The implementation of SECs will have to settle on a limited role as provided in the ongoing JDC-1 reform, emphasizing a science-based regulation. The regulatory update to accommodate NBTs through a product-based approach is scientifically sound, but further steps should be directed towards regulatory harmonization. The current initiatives will not only help the Philippines regain its momentum, but also help sustain engagements in biotechnology in the coming years.
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The gap labels system of taiwan, magna carta for science & tehnology personnel: bridging the gap to keep the filipino s&t workers.
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Introduction: The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework in the Philippines that can mount an adequate and well-coordinated response. The objective of the study was to assess, strengthen, and harmonize efforts in biorisk management through the development of a National Biorisk Management Framework. Methods: The development of the National Biorisk Management Framework was carried out in two phases: (1) assessment of the current biosafety and biosecurity landscape and (2) framework development. Results: This study identified policy gaps in the incorporation of biosafety in course curricula, professional development, and organizational twinning. The desired policy outcomes focus on increasing the capacity and quality of facilities, and the development of the biosafety officer profession. The tabletop exercises revealed weak implementation of existing protocols and unclear coordination mechanisms for emergency response. Based on these, a framework was drafted composed of eight key areas in biosafety and biosecurity, and four key contexts in risk reduction and management. Discussion and Conclusion: Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms toward harmonized risk reduction and management, (2) establishes and enforces guidelines on biosafety, biosecurity, and biorisk management, (3) regulates facilities essential for occupational safety and public health, and (4) is financed by the General Appropriations Act as part of the national budget.
Keywords: biorisk management; biosafety; biosecurity; policy analysis; policy gaps.
© Raul V. Destura et al. 2021; Published by Mary Ann Liebert, Inc.
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2019, Iapa Proceedings Conference
International Journal of Scientific and Management Research
Angela Austria
This study was conducted to narrate the experiences of farmers and local government unit (LGU) employees in the Municipalities of Villasis, Pangasinan and Cuyapo, Nueva Ecija on genetically modified organisms (GMOs) particularly GM crops. This study also sought to identify the challenges encountered by the farmers and the LGUs in using GM crops and it also determined how the LGUs monitor and help the farmers in GM crop production. The findings of this study served as the basis for creating possible courses of action that the LGUs could do to help the farmers, especially the low-production farmers, maximize their production by using GM crops. The researchers employed qualitative research design, particularly the narrative approach through the conduct of one-on-one interviews with farmers and focus group discussion with LGU employees then specific themes were formulated to describe the experiences and challenges encountered by the farmers and the LGUs and how the LGUs monitor and help...
Lex Publica
Saida Talukder Rahi
Multiple challenges of Genetically Modified Organisms (GMOs) have led different countries to adopt quite different approaches for GM foods and crops. Among Developing Countries, In Bangladesh, commercial cultivation of GM crops is poised to receive approval, but the country faces constraints in reducing risks associated with the release and handling of GMOs. The primary goal of this study is to examine the various laws, policies, and regulations that Bangladesh has to regulate issues related to GM foods and to determine how current laws are applied to assess and manage risks associated with the introduction of GM crops. An analytical and qualitative approach was applied in this regard. In general, the concepts of intellectual property rights, trade, food safety, labeling, and public policy are relevant to GMOs. It is found that there are currently no laws enacted particularly to address the biosafety of GM crops and foods. Only the Biosafety Guidelines, a non-binding document, cover...
International Journal of Scientific World
Jacqueline Bagunu
Susana Carro-Ripalda , Joanildo Burity , brian wynne , Phil Macnaghten , Susana Carro
MARINA ABDUL MAJID
Malaysia's Biosafety Act 2007 proposes to address socio-economic considerations of Genetically Modified Organisms(SECGMOS) under Section 35 which mirrors Article 26(1) of the Cartagena Protocol on Biosafety(CPB). There exists a disagreement among parties to the CPB concerning the scope of SECGMOS under Article 26. Past negotiations of the CPB indicates that developing countries such as Malaysia and the African block had proposed for SECGMOs for fear that the introduction of GMOs would pose as a threat socially, economically and culturally to developing countries. SECGMOS complements social development, an aspect of sustainable development. Without a parameter for the scope of SECGMOS within the CPB, Malaysia will use its own discursion to implement Section 35 of its Biosafety Act 2007. This paper seeks to identify the means in enabling Malaysia to implement Section 35 of the Biosafety Act 2007. The methodology adopted in this study combines relevant references such as legislatio...
Woldeyesus Sinebo
The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human health is recommended.
kavita Gupta
World Journal of Advance Research and Reviews
Sanjay Prakash Srivastava (Professor, Law)
The production of genetically modified crops for commercial release and agriculture resulting in a number of changes in the life style of an individual and farmers particularly. Scientists who analyze the impact of agricultural biotechnology from the socio-legal perspective; looked the tall claim of genetic engineering with suspicion. They claim alterations can change the organism's metabolism, growth rate, and/or may have down side effect on external environmental factors. This research paper tries to explore and examine the concerns raised from the socio-legal perspective as society should have minimum scientific knowledge in reference to use of GMOs and its derivatives. It is concluded with the finding that a reasonable policy with regard to their use by the farmers and others stake holders need to be prepared.
Joanildo Burity , Phil Macnaghten
Susana Carro-Ripalda
Unless we examine why GM crops have not been universally ac- cepted as a public good, we will fail to understand the conditions under which ‘GM crops can help to feed the world’. The rise of genetically modified (GM) crops has been dramatic, but their uptake has not been the smooth nor universal transition predicted by its advocates. Controversy is present even in countries, such as the US, where approvals have been impressively rapid. All too commonly the regulation of GM crops has been challenged as inadequate, even biased. While public and regulatory debates about GM crops have been grid-locked in many parts of the world including the UK and EU, there are lessons to be learned from the global ‘rising powers’ who have experienced similar chal- lenges in governing GM, within their own cultural contexts. This research, undertaken by Durham University, in partnership with local research teams in Mexico, Brazil and India, and funded by The John Templeton Foundation under the banner ‘Can GM crops help to feed the world?’, reveals a diverse variety of factors that influence decisions surrounding the adoption of GM technologies, many of them cross-cultural and of global significance.
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The Journal of Peasant Studies
Tomas Larsson
Peter Newell
Madeline Suva
Godfrey Ramon
Journal of agricultural and Environmental Ethics
Anne I Myhr
World Development
Monika Szkarłat
Maite Salazar
Economic & Political Weekly
Krishna Ravi Srinivas
Daniel Valenzuela
Ronald Herring
Yaroslav Blume
ceri-sciences-po.org
Yves Tiberghien
Saturnina Halos
Ifpri Discussion Papers
Simon Mevel
International Journal of Engineering & Technology
Mohamad Hafis Aliaziz
Pablo Pellegrini
Kertha Patrika
orima davey
The COVID-19 pandemic has been a stark warning to the Philippines and the rest of the world: Good health is critical to economic and societal functioning, and countries that neglected their health sectors have reaped the consequences. At the same time, societal, medical, and regulatory attitudes toward health innovations such as telemedicine were upended, and the possibilities seemed limitless, if only for a few years. As priorities in 2024 turn toward economic recovery, it falls on health systems to retain their learnings from the pandemic and invest more heavily in technologies to strengthen health and care in the long term.
In the Philippines, matters of health care are often tethered inextricably to local politics. Concurrently, the humility and candidness of public discourse can be advantageous. Politicians, academia, and nongovernmental organizations alike are explicit on what needs to improve, and even government reports can be unusually blunt about their own performance. This clear-eyed view has partly translated into a steady improvement in health system capacity over the years.
Barangay (district) health stations have proliferated since 2004, and under-five mortality has halved since 1993. Sin taxes bring in revenue larger than the entire health budget, providing much-needed funding for UHC. Malaria has been suppressed, and additional laws on reproductive health, cancer, occupational safety, mental health, and integrated health services and financing have been passed.
In particular, the 2019 UHC Act marked a major milestone in equalizing access to health care. From a meager 38 percent coverage in 2000, all Filipinos will now be automatically enrolled, with health care increasingly delivered at the community level, focused on prevention, and integrated with the rest of the health system. The Department of Health (DOH) aims for Filipinos to be “among the healthiest people in Asia by 2040.”
Despite these advances, lifespans in the Philippines have risen relatively slowly since 1990 (Figure 1), and widespread stunting of children’s growth will continue to slow future advances in healthy life expectancy. This is not entirely an issue of income or geography—poorer countries such as India and larger archipelagoes such as Indonesia have lengthened lifespans more despite spending less. Such sobering statistics represent the unfinished work in Philippines health and care.
Towards successful aging in asia.
The price women pay for dementia: strategies to ease gender disparity and economic costs.
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Introduction. The Philippines is the first country in Southeast Asia to adapt a national biosafety guideline. The guideline, published in 1991, focuses on genetic engineering and other activities that require the importation, introduction, field release, and breeding of nonindigenous organisms. 1 The country signed into the Cartagena Protocol on Biosafety to the Convention on Biological ...
The document discusses issues related to biosafety policies in the Philippines regarding genetically modified organisms (GMOs). It explains that biosafety aims to manage risks from intentional or unintentional introduction of regulated materials. The Philippines started focusing on biosafety when local universities began using biotechnology. Draft guidelines emphasized safety of processes over ...
The Philippine Biosafety Regulations started out strong in biotechnology and leads the Southeast Asian Region. However, regulatory issues and concerns surfaced that slowed down the progress of the country. Initiatives are currently being done to answer and bridge the gaps. There is a need to establish a liability and redress mechanism to ...
Introduction: The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework in the Philippines that can mount an adequate and well ...
the current biosafety and biosecurity landscape and (2) framework development. Phase 1: Assessment of the Current Landscape Policy review. This step entailed a rapid scan and re-view of existing policies related to biosafety and biose-curity in the Philippines. Policies were searched in the laws and policies databases of six concerned government
Introduction: The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework in the Philippines that can mount an adequate and well-coordinated response. The objective of the study was to assess, strengthen, and harmonize efforts in biorisk management through the development of a National Biorisk Management Framework.
It is the responsibility of national governments to produce and implement evidence-based policies that apply the precautionary principle emphasized by the Cartagena Protocol on Biosafety.36 Spearheaded by the National Committee on Biosafety of the Philippines, the implementation of policies related to biosafety is a task shared by four ...
Abstract. This paper analyzes the government biosafety regulatory approach to genetically modified (GM) crops in the Philippines focusing on the interplay and politics of the different government ...
Discussion and Conclusion: Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms toward harmonized risk reduction and ...
Abstract. This paper analyzes the government biosafety regulatory approach to genetically modified (GM) crops in the Philippines focusing on the interplay and politics of the different government agencies (DOST-DOH-DENR-DA-DILG) that comprises the National Biosafety Committee of the Philippines (NBCP) in terms of entry permit applications of ...
Within Asia, the Philippines is on the front lines of the agro-biotechnology movement and was one of the first Asian countries to endorse commercialization of GM crops. 20. The Philippines has embraced agro-biotechnology as one method to improve national food security. 21. In 2004, the Philippines grew 0.1 million hectares of GM crops. 22
policies, legislation, regulations, and cross-cutting issues that surround biosecurity and biosafety in the Philippines and New Zealand. In terms ofbiosecurity encompassing biosafety in the local context, this study revealed that such a concept is not yet present in the Philippines, whilst, to some extent it is happening in New Zealand.
The document discusses the evolution of biosafety policies in the Philippines from the 1970s to present. It notes that the Philippines was the first developing country to establish a biosafety system in 1990 through an executive order. Since then the country has expanded its biosafety framework, signing international agreements and establishing new guidelines and committees. However, the ...
on biotechnology and oversees compli ance to biosafety policies. It form. lated and adopted the Philippines Biosafety Guide lines in 1991. The poster presented the organizational structure of the NCBP, the National Biosaf. ty Policies and Guidelines, and the mechanism of implementation. The guid. lines today, however, have been undergoi.
This is done by establishing safety measures that significantly reduce the likelihood of acquiring infections and accidents.[2] Manuscript revised August 17, 2021; accepted August 18, 2021. Date of publication August 20, 2021. This paper available online at www.ijprse.com ISSN (Online): 2582-7898.
set scientific, technical, and. procedural standards on actions by agencies and other sectors to promote biosafety in the Philippines; oversee the. implementation of the NBF; act as a. clearing house for biosafety matters; and coordinate and harmonize the efforts of all concerned agencies and departments in this regard. (Section 4.1)".
originated from the 1987 Report of the Ad-hoc Committee on Biosafety composed of representatives from the University of the Philippines at Los Banos, International Rice Research Institute, and Department of Agriculture. The ad-hoc committee, on the other hand, based its biosafety guidelines on those of Australia, United States and Japan.
This research paper tries to explore and examine the concerns raised from the socio-legal perspective as society should have minimum scientific knowledge in reference to use of GMOs and its derivatives. ... National Biosafety Policies and Local Ordinances Many national guidelines or rules have come in place to regulate the GMO crops and these ...
Genetically modified organisms and biosafety is sues. Dr. Jasleen Kaur 1. Dept. of Botany, Dyal Singh College, Lodhi Road, New Delhi-110003. Article History : Abstract: Genetic modification is a ...
4.6.1 Biosafety Policy Functions. 4.6.1.1 Assist concerned departments and agencies in formulating, reviewing, or amending their respective policies, measures and guidelines on biosafety; 4.6.1.2 Hold public deliberations on proposed national policies, guidelines, and other biosafety issues;
4.27.4 National Biosafety Framework for the Philippines (2006) The Framework covers all activities related to the development, adoption and implementation of all biosafety policies, measures and Guidelines and in making decisions concerning the research, development, handling and use, transboundary movement, release into the environment and ...
The Philippines is the first country in Southeast Asia to adapt a national biosafety guideline. The guideline, published in 1991, focuses on genetic engineering and other activities that require the importation, introduction, field release, and breeding of nonindigenous organisms. 1 The country signed into the Cartagena Protocol on Biosafety to the Convention on Biological Diversity in 2000.
This study examines the Philippine biosafety policies and their effectiveness in regulating biotechnology. The study found that 1) Philippine biosafety guidelines are consistent with international standards, 2) efforts are being made to strengthen research capacity and regulation, and 3) current research focuses on applying technologies developed elsewhere to local conditions due to limited ...
The COVID-19 pandemic has been a stark warning to the Philippines and the rest of the world: Good health is critical to economic and societal functioning, and c ... Power of Ideas Essays; Research and Reports Research and Reports. Back to Content Hub Research and ... Quintus Lim is an associate director of policy and programs for the ...