New Frontiers in Biosafety and Biosecurity

Raybould, Alan

doi:10.3389/fbioe.2021.727386

Cited by 5 publications

(6 citation statements)

References 36 publications

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“…Now, particular emphasis needs to be placed on mobilizing domestic and external financial resources to better sustain these efforts, including efforts toward institutionalizing the relevant policies through approved legislation or regulation. 31 …”

Section: Discussionmentioning

confidence: 99%

Strengthening Biorisk Management Capacities in Burkina Faso: Contribution of the Global Health Security Agenda

Dama¹,

Orelle²,

Nikièma³

et al. 2022

Health Security

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The Global Health Security Agenda and the International Health Regulations (2005) recommend that countries strengthen the capacity of their national laboratory systems to comply with the International Health Regulations. To efficiently and effectively direct these efforts, the US Centers for Disease Control and Prevention—in collaboration with the Ministry of Health Directorate of Laboratories, the African Society for Laboratory Medicine, and Integrated Quality Laboratory Service—assessed Burkina Faso's national laboratory system using the World Health Organization Laboratory Assessment Tool . Based on gaps observed in biorisk management, the Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) was developed to assess 10 public laboratories handling dangerous pathogens. This tool uses a specific scoring matrix with quantitative output. Composite assessment scores for the 9 primary modules (capacity areas) were reported, with the highest scores reported in cleaning, disinfection, sterilization, waste management (42%), and good laboratory practices (40%), and the lowest scores in biosecurity/biosafety (33%), documents/regulations (18%), emergency management (16%), and risk management (5%). To address challenges identified in the assessments, a set of activities was planned with a focus on biorisk management. Results from an evaluation conducted 1 year later, using the BSS LAT, showed an increase in the average score of all indicators from 25% to 45% and an increase in the biorisk management module score from 5% to 35%. This evaluation process was a decisive step toward strengthening the capacity of the laboratory system in Burkina Faso. Global Health Security Agenda investments and activities have made a lasting impact on improving biosafety and biosecurity in public health laboratories. To ensure sustainability, a strong laboratory quality management program based on a mentorship system is greatly needed.

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Section: Discussionmentioning

confidence: 99%

Strengthening Biorisk Management Capacities in Burkina Faso: Contribution of the Global Health Security Agenda

Dama¹,

Orelle²,

Nikièma³

et al. 2022

Health Security

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“…The United States argues that it will not issue policies for tighter monitoring of sophisticated biotechnology until biosafety and biosecurity hazards have been established, claiming that intellectual freedom for invention is also important, even though biosafety risks must be anticipated ( National Human Genome Research Institute, 2013 ). Although different countries have taken different regulatory paths, the principal goal of effective medical biotechnology regulatory policy, which includes “top-down” setting of general objectives by the active political leadership and “bottom-up” innovation in the application, is the elimination of risk or willingness to take an acceptable risk based on the value of the opportunity ( Raybould, 2021 ). China is seeking to call for prudent vigilance, building processes for assessing anticipated benefits as well as assessing safety and security threats both before and after initiatives are performed, to achieve a reasonable balance between precaution and innovation.…”

Section: Discussionmentioning

confidence: 99%

Towards Better Governance on Biosafety and Biosecurity: China’s Advances and Perspectives in Medical Biotechnology Legislation

Xue

Liu

2022

Front. Bioeng. Biotechnol.

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In this paper, we systematically investigated and assessed China’s evolving medical biotechnology legislative and regulatory regime. 89 laws, rules, measures, guidelines, and views from 1985 to 2022 were systematically analogized and 28 were found to be involved in medical biotechnology legislation, including the recently passed Biosecurity Law. We classified the legislations and performed a comparative analysis for their legal binding based on the legal subject and extent of application, then further analyzes some of the legislative challenges in governing medical biotechnology risks in the context of China’s upgrading its regulatory and legal regime in the last 3 years. We concluded that policymakers in China have now incorporated medical biotechnology-related biosafety and biosecurity into the national strategic goals of a “People-Centered” approach to establish and foster an ecological civilization, particularly in the aftermath of the “He Jiankui affair.” Instead of relying on a patchwork of existing regulations and measures relating to the emerging field of medical biotechnology, China is attempting to integrate a patchwork of existing regulations and measures into a comprehensive legal framework, such as the constitution, National Security Law, Biosecurity Law, administrative regulations, departmental and local rules, and has begun to use the Civil Code and Criminal Law to explicitly identify actions relating to medical biotechnology. In general, China follows the “precautionary principle” as it thinks that uncertainty in science and technology should not be used to justify delaying the adoption of measures to prevent injuries or dangers, stating that whoever advances biotechnology must face the burden of proof of no harm. There would be a need to impose oversight for prevention and precaution if any biotechnology breakthrough that carries risks on which no scientific consensus has been reached. We argued that the “top-down” formulation of general objectives by the active political leadership and “bottom-up” innovation in the implementation are the keys to achieving these goals. Given the rapid advancements in medical biotechnology, countries all over the world must examine the governance landscape around biosafety and biosecurity and quickly consider options for their own comprehensive, credible, and long-lasting regulatory frameworks and experiences learned from China’s governance will help chart a scalable future roadmap.

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“…Regulatory studies are more meaningful if the regulatory authority defines what is regarded as significant and potentially harmful changes, and the applicant conducts studies that address those changes. By implementing the innovation principle, regulators could also define potentially beneficial changes; this would provide a good balance by not focusing only on potential risks but also weighing them against benefits when arriving at a decision that would be in the national interest (Raybould, 2021).…”

Section: Discussionmentioning

confidence: 99%

“…GEd comprises powerful new techniques that could distribute innovation in agricultural biotechnology among a wider set of product developers and have more direct benefits to consumers (Lema, 2019). To realize these opportunities, any specific regulation of GEd needs to encourage innovation and ensure that the risks from using GEd products are acceptable (Raybould, 2021). Such an outcome is unlikely to be achieved simply by the wholesale application of current GM regulations to GEd products.…”

Section: History Of Adoption Of Gmos and Emergence Of Nbtsmentioning

confidence: 99%

Regulatory frameworks can facilitate or hinder the potential for genome editing to contribute to sustainable agricultural development

Mbaya

Lillico²,

Kemp³

et al. 2022

Front. Bioeng. Biotechnol.

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The advent of new breeding techniques (NBTs), in particular genome editing (GEd), has provided more accurate and precise ways to introduce targeted changes in the genome of both plants and animals. This has resulted in the use of the technology by a wider variety of stakeholders for different applications in comparison to transgenesis. Regulators in different parts of the world are now examining their current frameworks to assess their applicability to these NBTs and their products. We looked at how countries selected from a sample of geographical regions globally are currently handling applications involving GEd organisms and what they foresee as opportunities and potential challenges to acceptance of the technology in their jurisdictions. In addition to regulatory frameworks that create an enabling environment for these NBTs, acceptance of the products by the public is vitally important. We, therefore, suggest that early stakeholder engagement and communication to the public be emphasized to foster public acceptance even before products are ready for market. Furthermore, global cooperation and consensus on issues cutting across regions will be crucial in avoiding regulatory-related bottlenecks that affect global trade and agriculture.

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New Frontiers in Biosafety and Biosecurity

Cited by 5 publications

References 36 publications

Strengthening Biorisk Management Capacities in Burkina Faso: Contribution of the Global Health Security Agenda

Strengthening Biorisk Management Capacities in Burkina Faso: Contribution of the Global Health Security Agenda

Towards Better Governance on Biosafety and Biosecurity: China’s Advances and Perspectives in Medical Biotechnology Legislation

Regulatory frameworks can facilitate or hinder the potential for genome editing to contribute to sustainable agricultural development

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