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.