European Union: Gene Drives

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

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

  • ‘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

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 intense opposition from environmental groups. They claim gene drive insects or other products could spread across borders and possibly result in unforeseen consequences to the environment. During the 2016 World Conservation Congress, a small group of activist NGOs, and some government representatives and scientific and academic institutions voted to adopt a moratorium on supporting or endorsing research into gene drives, calling it “genetic extinction’. In addition, a group of conservationists, including Dr. Jane Goodall, signed an open letter calling for a halt to gene drive proposals. World governments rejected the moratorium proposal at the 2016 UN Biodiversity meeting. The ETC Group, an international organization, wrote a scathing report in 2018 arguing that gene drives will “find their real use in food and farming by agribusiness” and that a moratorium should be in place until gene drives can reliably be contained. Counter NGO groups, including Target Malaria, Island Conservation and Genetic Biocontrol of Invasive Rodents Program, have adopted the opposite position, stating that gene drives are “vital to the future of restoration and critical in preventing extinctions”.

Additional Resources

 

Click on countries (eg. Brazil, US) or regions (eg. European Union) to find what agricultural products or therapies are approved or in development and their regulatory status.

Hotspots Background

EUROPEAN UNION

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

BRAZIL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

NEW ZEALAND

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

UNITED STATES

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

AUSTRALIA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

CANADA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

CHINA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

UNITED KINGDOM

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives