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 October 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. It intends to present the final report at the end of 2020. 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.
European Genetic Engineering Law
In the EU, Directive 2001/18 regulates the conditions under which genetically modified organisms (GMOs) may be released into the environment. It is undisputed that gene drive organisms are GMOs.
The implementation of the requirements of the EU directive in national law is mandatory for all member states. Only EU institutions can make changes to the directive. Since 2015, however, member states have been able to prohibit the cultivation of genetically modified plants on their territory even if approval has been granted at the EU level (opt-out). In theory, this also applies to gene drive organisms.
Directive 2001/18 obliges member states to take all necessary measures to avoid negative effects on the environment and human health resulting from the release of a GMO. Both protection goals are of equal importance. It is therefore not possible to weigh up conceivable advantages for human health against possible disadvantages for the environment. The reference to the precautionary principle obliges the relevant authorities to take measures to prevent adverse effects, even if there is not yet complete scientific or technical certainty or knowledge concerning such an effect.
Legal interpretation of the EU Deliberate Release Directive with regard to gene drive organisms
According to the EU Genetic Engineering Directive, any release of a GMO requires authorisation, which may only be granted if, on the basis of prior risk assessment involving the member states and the European Commission, it has been established that the release will not have any harmful effects on human health or the environment. Protection of the environment and human health must be ensured in accordance with the precautionary principle. The period of validity of the authorisation may not exceed ten years. The released GMO and its potential effects must be monitored throughout the period in accordance with a monitoring plan to be submitted by the applicant.
The aim of the directive is to prevent the uncontrolled spread of GMOs in the environment and their outcrossing to other organisms. The mere spread of a GMO in the environment beyond the planned site of release is assessed as a negative effect. If there is risk to the environment or human health, authorisation for release may not be granted.
Recital 4 of the Directive underlines the specific problem of the deliberate release of GMOs into the environment: ‘Living organisms released into the environment in large or small quantities for experimental purposes or in the form of commercial products may reproduce in the environment and spread beyond national borders, potentially affecting other Member States. The effects of such releases may be irreversible”.
To identify and assess risks to the environment and human health, a risk assessment must identify any new risks before any GMO is released into the environment. Annex II of the Directive sets out the requirements for this risk assessment. It requires the assessment of all intended and unintended, direct and indirect, immediate and delayed, long-term and cumulative long-term effects of the release. Cumulative long-term effects include effects of the released GMOs on food chains, flora and fauna and biodiversity. The effects on altered population dynamics and the genetic diversity of competitors, prey, hosts, symbionts, predators, parasites and pathogens must also be included in the risk assessment.
It is also stipulated that the risk assessment may not exclude possible negative effects because they are unlikely to occur. Furthermore, it is stated that there is no distinction between significant and other (negligible) negative effects. The Directive therefore prescribes a worst-case scenario as the basis for the risk assessment and requires the assumption that any potential adverse effects will occur.
The Directive recommends that, for safety reasons, the release of a GMO should be carried out step by step and that the next step should only be taken if the assessment of the previous steps did not indicate that any adverse effects on human health or the environment were to be expected. However, a step-by-step procedure is not possible due to the nature of gene drive organisms: sufficiently reliable evidence of the innocuousness of a GMO can only be provided if the GMO has been released into the environment and there has been no evidence of risks to the environment and human health for several generations. Even the release of just a few gene drive organisms, however, results in their possibly irrevocable spread in the environment. According to the current state of research, once GDOs have been released, their spread cannot be limited or retrieved, nor can their effects in nature be reversed.
In order to take account of the particular risk posed by a self-propagating release into the environment, the authorisation of a GMO can be granted for a maximum of 10 years. After this period, it must either be renewed or expires. Once the authorisation has expired, the GMO must no longer be detectable in the environment. It is not clear how this rule would be enforced in relation to GMOs. Directive 2001/18 was designed and adopted to regulate the release of genetically modified crops. It assumes that the effect and spread of GMOs in nature would be limited in space and time. However, according to the current state of research into gene drives, this is not possible.
Release of gene drive organisms not possible within the framework of current EU law
The purpose of gene drive organisms is to spread independently in the environment, to crossbreed with wild conspecifics and to pass on their modified genes to as many offspring as possible in order to spread them throughout the population of a species. Because this is clearly contrary to the current provisions of Directive 2001/18 in relation to environmental protection, European law does not allow the release of a gene drive organism into the environment. However, any release of a GMO would be subject to mandatory authorisation.
EU member states are therefore legally obliged to ensure that no GMOs are found within their political borders. Article 4 of Directive 2001/18 also stipulates: ‚ Member states shall ensure that the relevant authority organises inspections and other control measures as appropriate to ensure compliance with this directive. In the event of a release of GMO(s) or their entry onto the market as or imports for which no authorisation was given, the member state concerned shall ensure that necessary measures are taken to terminate the release or entry onto the market, to initiate remedial action if necessary, and to inform its public, the Commission and other member states‘.
For this reason, it is in the self-interest of the EU and all EU member states to prevent the release of GDOs, which can also reach their territory, including in states outside the EU.