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Norway: Gene Drives

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Limited Research, No Clear Regulations

A moratorium on gene drives has been recommended, but no regulations in place.

Worldwide, gene drive regulations are in flux. Gene drives are being developed using transgenic technology (GMOs) that contain foreign genes, as well as gene editing, including CRISPR (synthetic gene drives), which do not, complicating regulatory oversight as gene editing and GMOs are often regulated differently.

In 2017, the Norwegian Biotechnology Advisory Board recommended a moratorium on the use of gene drives until international regulations for handling and risk assessment are in place. Gene drive research, including field trials, could be allowed if they are able to be contained. Research field trials must be developed according to EU and UN guidelines.

Norway has a history of fierce opposition to transgenic biotechnology (GMOs) dating to the early 2000s. Biotechnology in Norway is regulated by the Ministry of Agriculture, the Ministry of Environment and the Ministry of Health. Genetically engineered organisms are regulated by the Gene Technology Act, one of the world’s strictest, which requires that genetically modified products contribute to sustainable development in order to be approved. 

Products

None

Regulatory Timeline

2017: Norwegian Biotechnology Advisory Board proposes final recommendations for how gene drives should be regulated, including a moratorium on the use of gene drives until international regulations for handling and risk assessment are in place.

2001: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.

1993: Gene Technology Act finalized, which states products should be ethically justified, sustainable and provide societal benefits.

1992: Bioteknologirådet (Biotechnology Council) established. It has since been a consultative body for the government and parliament on both ethical and environmental concerns related to genetically engineered crops for import. Bioteknologirådet has developed close relationships with anti-biotech activists and has yet to recommend importing even a single genetically engineered food crop.

NGO Reaction

The original opposition to biotechnology in Norway was spearheaded by the Norwegian Institute of Gene Ecology (GenØk) whose purported vision is the safe use of biotechnology. In 2006, GenØk obtained status from the coalition government as the National Center for Biosecurity. It produced a series of studies purporting to demonstrate the dangers of insect-resistant Bt corn, which was used as a pretext to suspend the cultivation of Bt corn in Europe, leading to widespread criticism by mainstream scientists. GenØk became tied very closely to the Biotechnology Council, even exchanging board members, in effect blocking all innovation in the crop biotechnology sector. GenØk has consistently promoted the work of anti-GMO scientists including the discredited findings of French scientist Gilles-Éric Séralini. It also promotes activist documentaries, such as OMG GMO, scathingly criticized by scientists and reviewers.

Many environmental advocacy groups led by a consortium of 18 organizations known as GMO-Nettverket (GMO-Network) are also active detractors of biotechnology in Norway. The organization includes Greenpeace Norway, Friends of the Earth Norway and numerous organic groups The GMO-Network calls for a “precautionary approach to GMOs” and claims they have “adverse effects on the ecological system and cause unacceptable trouble for conventional and organic farming.” Although the group claims that it is “not against GMOs in general,” they maintain there has not been sufficient “research on long-term consequences for the environment and human health”.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which gene drive products and processes are approved or in development and their regulatory status.

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Gene Drive Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene drives regulated through existing biotechnology laws.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Gene Drives:
Genetic engineering technology used to transmit a characteristic throughout a wild population. For example, it can be used to develop mosquitoes that only have female offspring. If released into the wild, these mosquitoes would breed with wild malaria-carrying mosquitoes and over time would eliminate the population. Scientists are interested in using this technology to help eradicate disease-carrying insects and control invasive species, but questions about how gene drives will be directed and controlled are still being fleshed out.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionGene DrivesGene Drive Rating
Japan11
Brazil88
Canada88
Russia11
Argentina11
Israel11
Australia44
China11
US44
Chile11
New Zealand44
Ukraine11
Central America11
Paraguay11
Uruguay11
India11
UK22
Mexico11
EU22
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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