Policy Recommendations
To date, no international agreement specific to gene drives exists to regulate the research and release of gene drive organisms, nor are there any specific national or supranational laws. Nevertheless, Target Malaria has announced first release trials with gene drive mosquitoes for the year 2024. So far, however, not only are internationally binding specific laws lacking, but also adequate, scientifically based concepts and methods for risk assessment, evaluation and management as well as for monitoring in the environment.
There is not even a central register of all research and development projects currently being carried out in connection with gene drives. There is also a lack of a conceptual foundation for technology assessment that goes beyond pure risk assessment. A social discussion on the circumstances under which the release of a GDO could possibly be justifiable, even ethically necessary, has not seriously begun, neither at the national nor international levels.
Against this background, the imperative of the moment seems to be that the international community takes sufficient time to deal with this new, global challenge. This is the prerequisite for the development of a common concept for dealing with gene drives, based at the United Nations, which will bindingly regulate the fundamental ecological, medical, ethical, cultural, scientific and international legal issues involved.
Save Our Seeds recommends
The European Union should work for a global moratorium on all releases of GDOs, to be adopted at the 15th Conference of the Parties (COP) to the UN Convention on Biological Diversity (CBD) that will take place in the second quarter of 2022. The EU should make clear that such releases are prohibited within the European Union under current legislation and that it will take action against any release that could reach the territory of the Union in the short or longer term by all available means.
In Save Our Seeds’ view, the below points are essential preconditions for reaching agreement on lifting a global moratorium, which will be considered on a case-by-case basis. It is, of course, the nature of an open-ended process of agreement involving all parties that such criteria can change in the course of the discussion. Whether this moratorium should be converted into a permanent and general ban or whether in individual cases the release of gene drive organisms is justified or even necessary also depends on the criteria to be developed.
Because even individual, unintentionally released GDOs could spread uncontrollably over time and territory, high laboratory safety standards for handling GDOs, adapted to the respective organisms, are of global importance and urgency. An essential prerequisite for adequate safety measures, but also for further discussion, is a central register of all gene drive research and related field trials, which should include a precise description of the organisms, the gene drive constructs and the objectives being pursued.
A comprehensive, forward-looking technology assessment involving all potentially affected states as well as indigenous peoples and local communities should go beyond the purely scientific investigation of environmental and health aspects and lay the foundations for discussing ethical, social and other societal issues and challenges and appropriate decision-making processes. This includes, among other things, the evaluation of objectives, whether they can be achieved by other means and the costs and benefits for each group.
Due to the international nature of the possible global consequences of the release of GDOs, international standards and procedures are also required for their approval. Crucial for this is the involvement and equal participation of all potentially affected parties. This refers first of all to states, but also specifically to indigenous peoples and local communities as defined in UN Declaration 61/295 on the rights of indigenous peoples and Declaration 73/165 on the rights of small farmers and other rural workers. Such decisions must be based at least on the principles of free prior informed consent.
Any release of GDOs should be subject to a sufficiently verified method for their removal from the environment. In addition, temporal or spatial controllability should be ensured and thus limitability of the effect and spread of the orgamism.
Both during the operation of a global moratorium on the release of gene drive organisms into the wild and in the event of a justified lifting of a moratorium, there should be specific and internationally binding liability and compensation rules that also address unintentional or illegal releases of gene drive organisms and the resulting damage.
In addition to the already existing ban on the use of biological weapons under the UN Biological Weapons Convention, research on gene drives should require proof that the GDOs developed have no (dual use) potential to be misused as weapons.
The precautionary principle, as embedded in EU Directive 2001/18, can only work if effective measures can actually be taken to protect the environment and human health in cases where this appears necessary. Retrievability (controllability in time and space) is a crucial prerequisite for this. If, in the course of an environmental risk assessment of Gene Drive organisms, it is determined that this retrievability is not guaranteed, this should be considered an exclusion criterion for GDO approval in order to implement the precautionary principle. The risk assessment should then be terminated and any release of the gene drive organism prohibited.