Governance
Videos and papers on regulatory frameworks and oversight mechanisms relevant to gene drive technologies
Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission
24859S. L. James, B. Dass and H. Quemada, Transgenic Research, 32:17. 2023-03-15 15:00:05.
Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.
GeneConvene Global Collaborative Webinar Series | Demystifying the Convention on Biological Diversity – Seven Videos
21940Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2022-04-28 12:39:49.
The Convention on Biological Diversity (CBD) is an international agreement aimed at providing the legal framework for country cooperation to conserve biodiversity, while also enabling its sustainable use, and providing for fair and equitable sharing of the benefits derived from that use. It became effective in 1993 when the first 30 countries signed it, but now has 196 parties. Biotechnology figures prominently in this agreement, since one of its major goal is to "promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to the results and benefits arising from biotechnologies." The CBD provides the basis for regulations on biotechnologies, particularly genetically engineered organisms (including gene drive organisms). While the convention, and its subsidiary agreements, have a significant impact on the regulatory environment within which synthetic gene drive research takes place, the procedures and decision-making processes connected with the CBD are often not transparent to researchers and others who do not closely follow the proceedings.
Regulatory and governance considerations for gene drive research
32181ISAAA Inc., 2021-06-22 12:36:13.
GeneConvene Global Collaborative Webinar Series | Engineered Gene Drives: Policy and Regulatory Considerations Webinar Series October-December 2020
14808Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-22 19:38:17.
In this series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured. Each seminar is ~60 minutes in length followed by questions and answers.
