Regulation of Gene Drive Organisms at EU Level
The political debate on the regulation of gene drive technology at the European level is still in its infancy. As concrete applications for the use of gene drives in the EU lie in the future, the political debate has so far concentrated on the EU’s position in the negotiations of the UN Convention on Biological Diversity (CBD).
Here we present the current state of debate and decision-making by European institutions:
In January 2020, the European Parliament adopted a resolution calling on the European Commission and the EU Council of Ministers to support a global gene drive moratorium at the forthcoming Conference of the Parties to the UN Convention on Biological Diversity (COP 15) in China in May/June 2020. In addition, MEPs called for the new post-2020 global biodiversity framework to be based on a number of key principles, including the precautionary principle, a rights-based approach to involving stakeholders in the development of legislation affecting them and mandatory prior technology assessment of new technologies that could have a negative impact on biodiversity. The MEPs followed a joint call from 50 European NGOs, experts and foundations.
In June 2021, the EU Parliament presented an own-initiative report 2020/227 on the EU Biodiversity Strategy, citing explicit reasons for concern as to why gene drive organisms should not currently be released for precautionary reasons, including explicitly for conservation purposes. The Parliament became even more specific in October 2021 when it adopted Resolution 2020/2274, which states that no so-called development funds should be used to promote genetic engineering.
Prior to the 14th Conference of the Parties (COP) of the CBD in Egypt, the EU Council of Ministers recognised potential adverse impacts of gene drive organisms on biodiversity for the first time and considered it necessary to apply the precautionary approach of the Convention.
In July 2018, the European Commission commissioned the expert group ‚European Group on Ethics in Science and New Technologies‘ (EGE) to draw up an opinion and political recommendations on the ethical, social and legal effects of new genetic engineering methods (genome editing) on humans, animals and plants. It is expected in spring 2021. In this context, a round table was held in Brussels in October 2019, at which participants from science, industry, politics and civil society discussed the ethical issues surrounding new applications of genetic engineering, including gene drives.
The risk assessment carried out as part of the approval process for a GMO is performed by the European Food Safety Agency (EFSA), which then develops specific guidelines for its implementation.
Both the guidelines on environmental risk assessment and the guidelines on risk assessment of genetically modified animals are relevant for gene drive organisms. Should plants also be modified using gene drives in the future, the guidelines for the risk assessment of food and feed from genetically modified plants would also be relevant. For genetically modified plants specifically, there are also guidelines for post-market environmental monitoring (PMEM), which regulate the management and monitoring strategies for released genetically modified plants.
At the time of printing, no genetically modified animals or products derived from them have been approved for market in the EU. In fact, no applications have been submitted. Nevertheless, guidelines for the risk assessment of genetically modified animals do exist to assist future applications.
These guidelines for the risk assessment of genetically modified animals, published by the EFSA in 2013, already include consideration of horizontal gene transfer by gene drive systems in the section on insects, among others. Since 2013, several scientific panels have dealt with the risk assessment of synthetic biology applications and have seen a need for action on gene drives. The Scientific Committee of the French High Council for Biotechnology (Haut Conseil des Biotechnologies, HCB) concluded in an opinion in May 2017 that the risk assessment criteria of Directive 2001/18/EC were applicable to gene drive organisms. However, it noted that GDOs introduce new elements and objectives that require adaptation of the existing risk assessment paradigm.
In June 2018, the European Commission asked the EFSA to assess whether the existing guidance on risk assessment of genetically modified animals was sufficient to identify possible new risks to the environment and human and animal health, or whether it needed to be adapted. However, this directive does not include the mandate to develop new guidelines. Nevertheless, the technical and scientific expertise on risk assessment of GDOs developed as a result of the mandate is to be taken into account when considering the development of guidelines for the risk assessment of gene drive organisms under the Convention on Biological Diversity and its Cartagena Protocol on Biosafety.
In May 2019, the EFSA organised a public hearing on the state of its deliberations. The final report was submitted in October 2020 and concludes that EFSA’s guidelines are adequate but insufficient for environmental risk assessment, molecular characterization and post-market monitoring of GDOs. However, the composition of the scientific working group that was commissioned by the report’s constitution has been criticised for being biased. According to research by the Brussels-based non-governmental organisation Corporate European Observatory (CEO), all six members of the working group have conflicts of interest in the development of GDOs, as they work in companies or research groups whose activities fall within the remit of the EFSA. Three of the experts have financial relationships with organisations developing gene drives, including Target Malaria and the US military agency DARPA.