What comes next?
Gene drive technologies are being researched and developed mainly in academic institutions as evidenced from published scientific research. Some of these academic groups have spun off small biotechnology companies to pursue product development. Currently there is no evidence that major multinational companies are involved in or have an interest in gene drive technologies, especially those that are self-sustaining.
Perhaps, depending on the type of gene drive strategy and the proposed target organism.
- Self-sustaining gene drive technologies are being designed as long-term, durable, and low-cost solutions requiring few additional inputs following the release of organisms containing the technology. A product that is highly species specific, will not need to be reapplied, and is intended to provide long-lasting effectiveness would most likely be marketed as a public good.
- Self-limiting gene drive products and non-replicating genetic biocontrol technologies, such as SIT, are likely to require regular applications of the technology over space and time in order to maintain their intended effects. These types of products may have more attractive characteristics for business enterprises.
- Public health products for use in developing countries are usually publicly funded and have very slim profit margins. Products for conservation purposes probably likewise will be publicly funded. Products for agricultural use might find a broader market, although this is not a given.
- Potential exists for local small business opportunities, for example providing services associated with product delivery and monitoring.
For more information:
https://ourworldindata.org/financing-healthcare
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National and local government agencies and not-for-profit foundations are currently the main funders of gene drive research.
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Several national agencies and international organizations have issued statements about biosafety and regulatory considerations for gene drive technologies. These include:
- The African Union High Level Panel on Emerging Technologies has formally supported research that would explore the use of this technology to control malaria.
- A number of national academic societies and government agencies have published recommendations for risk assessment of gene drive-modified organisms.
- Both the Convention on Biological Diversity and the International Union for the Conservation of Nature, in which many countries are members, are discussing gene drive technologies and new applications of synthetic biology.
For more information:
https://www.nepad.org/publication/gene-drives-malaria-control-and-elimination-africa
https://www.nepad.org/publication/position-paper-strengthening-au-member-states-regulatory-capacities-responsible
https://portals.iucn.org/library/node/48408
https://www.who.int/publications/i/item/9789240025233
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The Convention on Biological Diversity (CBD) is an international agreement under the United Nations Environment Programme (UNEP) that aims to conserve biodiversity, enable the sustainable use of the components of biodiversity, and enable fair and equitable sharing of benefits arising out of the utilization of genetic resources. 196 countries currently (2022) are Parties to this agreement. The CBD considers organisms containing engineered gene drives as Living Modified Organisms (LMOs; also referred to as Genetically Modified Organisms, or GMOS). Since gene drive-modified organisms are LMOs, the CBD considers the Cartagena Protocol on Biosafety (CPB) as the appropriate umbrella under which policies regarding their transboundary movement are developed. The CBD has thus far recommended that a precautionary approach should be taken with regard to decisions on activities in the field and recommended further consideration of risk assessment methods. Work is underway under the CPB to develop additional voluntary guidance materials to support case-by-case risk assessment of living modified organisms
containing engineered gene drives.
For more information:
https://www.cbd.int/doc/c/a763/e248/4fa326e03e3c126b9615e95d/cp-ra-ahteg-2020-01-05-en.pdf
https://www.cbd.int/doc/c/2c62/5569/004e9c7a6b2a00641c3af0eb/cop-14-l-31-en.pdf
https://www.youtube.com/playlist?list=PLbopRNGowKJ-LM6kEKvmwe5WZA30fR6G6
https://www.cbd.int/doc/c/c750/0f0a/6cd323ebe26a29d55f4e294b/cp-mop-10-l-08-en.pdf
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The precautionary principle is based on a statement from the Rio Declaration on Environment and Development, which states “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” The Preamble to the Convention on Biological Diversity also states, “Where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat.” The precautionary principle is often interpreted to mean that if there is uncertainty regarding whether a new technology may cause harm to the environment, it should not be introduced. Therefore, while the principle of precaution as written refers to affirmative action to prevent damage to biodiversity, in the case of GMOs (LMOs), it has been applied to prevent actions that have the potential to harm biodiversity when uncertainty about safety remains.
This perspective assumes that the status quo always is preferable to a new activity that may carry risks.
For more information:
https://www.un.org/en/development/desa/population/migration/generalassembly/docs/globalcompact/A_CONF.151_26_Vol.I_Declaration.pdf
https://iepi.mcmaster.ca/research/pillars-of-research/infectious-disease-management/research-syntheses/precautionary-principle/
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Membership of the International Union for the Conservation of Nature (IUCN) consists of States and government agencies as well as other organizations and institutions with interest in nature conservation. IUCN recently issued a report on the potential use of synthetic biology, including gene drives, for conservation recognizing the need for case-by-case assessments and decision-making for each different application of synthetic biology. Discussions are ongoing regarding the development of an IUCN policy on the implications of synthetic biology in nature conservation.
For more information:
https://www.iucn.org/theme/science-and-economics
https://portals.iucn.org/library/node/48408
https://www.iucncongress2020.org/motion/075
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We do not yet know the answer to this question as it is dependent upon many variables, including clarification of the regulatory pathway and collection of information needed to support risk assessment for different gene drive systems and in different venues.
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