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
- Genetic Literacy Project’s FAQ on gene editing
- Outreach Network for Gene Drive Research
- Gene drive research: Why it matters
- Harnessing Gene Drive
