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European Union: Gene Drives

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Mostly Prohibited

The EU is in the process of deciding whether gene drives will be permitted and if so, how they will be regulated.

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.

There are currently no finalized regulations specifically for gene drives in the EU. Gene drives fall under the strict regulations for gene edited organisms that were promulgated in 2018 when the European Court of Justice (ECJ) ruled that gene editing shall be regulated under the 2001 GMO Directive that heavily restricts transgenic organisms created using genes from another species, even though most gene editing techniques do not result in the introduction of “foreign” genes. This ruling reaffirmed the EU’s regulation of the process used to create genetically engineered seeds rather than the characteristics of the final products, as is the case in the US and many other countries.

In 2019, the European Food Safety Authority (EFSA) held a workshop to discuss environmental risks associated with the release of gene drive modified insects into the environment. An EFSA expert working group, mandated by the EU Commission, is developing recommendations for regulations on gene drive modified organisms, expected by the end of 2020.

If allowed, gene drives will be regulated by the EFSA, the EU Commission and EU countries. One of the requirements for the approval of genetically modified animals is a comprehensive environmental risk assessment. In 2013, the European Food Safety Authority issued guidance on how to complete environmental risk assessments of all genetically modified animals. It is likely that any regulatory scheme for gene drives will require environmental risk assessment following this guidance.

Products/Research

  • In 2019, scientists began large-scale releases of gene drive mosquitos for the first time in a high-security lab in Italy to test the gene drive.
  • ‘Switchable’ gene drive: Researchers at the University of Bath and Cardiff University published a study demonstrating the effectiveness of a ‘switchable’ gene drive that can be “turned on or off” depending on whether an organism ingests a specific environmental friendly amino acid.
  • Malaria-carrying mosquito: Researchers at Imperial College London eliminated a caged population of the malaria-carrying mosquito Anopheles gambiae using a gene drive, the first time experiments have been able to completely block reproduction of a complex organism in the laboratory.
  • Female-less mosquitoes: Another mosquito gene drive strategy developed by Imperial College “propagates a gene that sterilizes all female mosquitoes (which could suppress specific mosquito populations to levels that will not support malaria transmission)”.
  • Female-less mice and rats: Researchers from Scotland developed two types of gene drives in mice and rats that could be used in the future to help control invasive species.

Regulatory Timeline

2020: EU lawmakers call on the EU Commission to push for a global prohibition on the release of gene drive technologies into the wild. The advisory vote said that the moratorium should also cover field trials.

2019: The European Food Safety Authority (EFSA) holds a workshop to discuss how gene drives should be regulated. Recommendations expected by the end of 2020.

2019: A group of European organizations sign an open letter arguing that the 2018 European Court of Justice (ECJ) ruling that all gene editing techniques would be regulated as genetic modification hinders the development of products that would benefit European consumers and increase agricultural sustainability.

2018: European Court of Justice (ECJ) rules that organisms developed through gene editing are genetically modified organisms (GMOs) and are subject to the same regulations as transgenic organisms, rejecting a regulatory exemption or the issuance of a revised directive.

2017: European Advocat General, who leads the European Court of Justice case assessing gene editing, releases a statement suggesting that while organisms that have undergone gene editing should be considered GMOs, they could be exempted from strict regulation if no foreign DNA was inserted.

2016: French government asks the ECJ to interpret the 2001 GMO Directive in light of gene editing techniques, including New Breeding Techniques (NBTs) that have since been developed.

2012: The European Food Safety Authority (EFSA) issues two opinions (here and here), stating that the 2001 GMO Directive regulations should apply to gene editing.

2013: The European Food Safety Authority issues a protocol for environmental assessments of all genetically modified animals.

2001: European GMO Directive replaces the 1990 GMO directive. The process of developing organisms altered through genetic modification is strictly regulated. Requirements include environmental risk assessment as well as traceability, labelling and monitoring obligations.

1990: The first Directive on GMOs establishes the definition of a GMO and a legal framework for the development of the biotechnology. The Directive introduces a focus on regulating the process used to create the seed rather than the characteristics of the final product.

NGO Reaction

Gene drives face fierce opposition from certain environmental advocacy groups, which claim that modified creatures might spread across borders and adversely impact the environment in unseen ways—claims most scientists say are overblown. The Canadian-based, international organization ETC Group and more than 200 global anti-GMO activists and NGOs published an open letter in 2016 opposing gene drives and called for a global moratorium. During the 2016 World Conservation Congress, a select group of NGOs, environmental activists and some scientists voted to adopt a moratorium on supporting research into gene drives. The moratorium call was rejected at the 2016 United Nations Convention on Biodiversity (CBD). Counter NGO groups, including Target Malaria, Island Conservation and Genetic Biocontrol of Invasive Rodents Program, have adopted the opposite position, stating that “gene drive is vital to the future of restoration and critical in preventing extinctions”.

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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Argentina

Argentina

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Mexico

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Russia

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Chile

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Paraguay

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India

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Africa

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Ukraine

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Southeast Asia

Central America

Central America

Colombia

Colombia

Norway

Norway

Ecuador

Ecuador

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.