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Policy and Regulation » Europe

Title: Statement on Gene Drives by the Norwegian Biotechnology Advisory Board
Publication date: December 29, 2017
Posting date: December 29, 2017

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

 

Dear Friends and Colleagues

Statement on Gene Drives by the Norwegian Biotechnology Advisory Board

In February 2017, the Norwegian Biotechnology Advisory Board issued a Statement on Gene Drives stating that the technology challenges established principles for risk assessment and regulation, and raised difficult ethical questions.

The Board recommended a moratorium on the use of gene drives until international regulations for handling and risk assessment are in place, and urged Norwegian authorities to be proactive in this work. Such regulations should be developed by for example relevant UN bodies, ensuring broad international consensus. Furthermore, all research and development of gene drives should be conducted openly and stepwise, and any proposal for release in the wild should be discussed in public international forums where various stakeholders are heard in the decision-making process.

We reproduce below the summary of recommendations.

With best wishes,

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____________________________________________________________________________

STATEMENT ON GENE DRIVES

The Norwegian Biotechnology Advisory Board
14 Feb 2017
http://www.bioteknologiradet.no/filarkiv/2017/02/Statement-on-gene-drives.pdf

This document was originally written in Norwegian, and has been translated for dissemination purposes.

New technology, called gene drive, has the potential to solve several significant health and ecological problems. At the same time, gene drives could have significant impact on the environment.

Gene drives make it possible, for the first time, to spread genetic changes in large populations of wild plants and animals, and thus override nature’s evolutionary constraints. Scientists are now working to develop gene drives to prevent the spread of malaria by eradicating mosquito species that carry the parasite, and to preserve endangered species, amongst other things. The technology challenges established principles for risk assessment and regulation, and raises difficult ethical questions.

With this statement, The Norwegian Biotechnology Advisory Board aims to be a driving force in the national and international debate on the use and regulation of gene drives.

Summary of recommendations:

The Norwegian Biotechnology Advisory Board believes it is urgently important to discuss the science, politics and societal consequences of the use of gene drives, both nationally and internationally. The Board urges Norwegian authorities to be proactive in the work towards establishing international regulations for gene drives.

The Norwegian Biotechnology Advisory Board believes the potential benefits of gene drives are large, but also recognize that there are significant risks associated with the use of the technology in nature. The Board holds forth that further research is required and should be encouraged. All research and development of gene drives should be conducted openly and stepwise, and any proposal for release in the wild should be discussed in public international forums where various stakeholders are heard in the decision-making process.

The Norwegian Biotechnology Advisory Board recommends a moratorium on the use of gene drives until international regulations for handling and risk assessment are in place. Such regulations should be developed by for example relevant UN bodies, ensuring broad international consensus.

A majority of ten out of fourteen board members recommend that field trials should still be allowed as part of research if the gene drive can be constrained (for example, on a remote island). A prerequisite is that such field trials are conducted according to guidelines developed by major international bodies such as the UN or EU. This ensures a stepwise process and emphasizes the precautionary principle, but allows a degree of risk where the potential benefit is significant.

A minority of two board members believe that a moratorium should include all field trials until a regulatory framework with broad international consensus is in place. They argue that the potential harmful effects of the use of gene drives can be substantial.

Another minority of two board members argue that potential eradication of malaria - a disease that claims half a million lives each year - is a weighty ethical reason to facilitate research and development of gene drives as much as possible, including limited field experiments where gene drives can be constrained (for example, on a remote island). It is sufficient that this research is carried out within existing national and international frameworks for GMO regulation and guidelines for research.

A joint Board recommends that research and development of self-regulating gene drives that only work over a few generations and other alternative methods of prevention and treatment of malaria and other proposed uses of gene drives, which are easier to control, should also be conducted.


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