Regulation of Gene Drive Organisms at the International Level

Since 2015, gene drives have been discussed within the UN Convention on Biological Diversity as part of its work on synthetic biology and as part of the discussions on risk assessment of living modified organisms (LMOs) as part of the Cartagena Protocol on Biosafety. The Convention was concluded in 1992 and came into force in 1993 ¹, with the EU joining the convention in the same year. At present, 195 countries are parties to the convention, including all EU member states and the United Kingdom, with the notable exception of the United States.

At the 14th Conference of the Parties to the UN Convention on Biological Diversity (CBD COP 14) at the end of 2018, delegates discussed a resolution on synthetic biology that was also meant to regulate gene drive organisms, Some parties introduced the demand for a moratorium on the release of gene drive organisms into the environment. In the run-up to the conference, more than 160 civil society organisations, mainly from the alternative agriculture movement and the global south, had demanded this in an open letter. However, the proposal did not find the necessary consensus, as African countries in particular, led by Nigeria and South Africa, spoke out against a moratorium.

Research on the basis of documents requested under US freedom of information provisions concluded that these countries’ votes were due to the influence of the Bill & Melinda Gates Foundation funded Target Malaria project. Internal correspondence and documents published as the Gene Drive Files revealed that Target Malaria had financed an agribusiness public affairs firm called Emerging AG. It recruited and coordinated about 65 scientists who became members of the Open-ended Online Forum on Synthetic Biology / Ad Hoc Technical Expert Group (AHTEG) of the CBD.

Decision 14/19 on synthetic biology, finally adopted at CBD COP 14, considers that research on gene drives is needed and that specific guidelines may be useful to support a case-by-case assessment of gene drive organisms. The decision also stated that the ‚free, prior and informed consent‘ of indigenous peoples and local communities ‚might be warranted‘ when considering the release of gene drive organisms. As a compromise² on the demands for a moratorium, the parties could only agree on non-binding precautionary considerations regarding the release of gene drive organisms into the environment.

This calls on the parties and other governments to apply a precautionary approach in line with the objectives of the Convention, taking into account the current uncertainties regarding gene drives. Finally, it urges the parties and other governments to consider the introduction of gene drive organisms into the environment, including for experimental, research and development purposes, only if the following conditions are met:

• Scientifically based risk assessments on a case-by-case basis.
• The existence of risk management measures to prevent or minimise any possible adverse effects.
• Where appropriate, ‘prior and informed consent’, ‘free, prior and informed consent’ or ‘authorisation and participation’ of potentially affected indigenous peoples and local communities are obtained, to the extent possible in accordance with national circumstances and legislation.

In addition, Decision 14/19 considers discussing the recommendations of a CBD Expert Group (SBSTTA) on synthetic biology – including gene drives – at the next COP.

The Cartagena Protocol on Biosafety is a legally binding protocol under the CBD. It has been ratified by 170 countries, including all EU membersStates, as well as the EU. The USA, Australia, Canada and Argentina are not party to the protocol.

The Protocol aims to ensure the safe handling, transport and use of living modified organisms (LMOs, broadly in line with the EU definition of GMOs) and to minimise adverse effects on biodiversity and risks to human health. Stipulations of the Protocol must be transposed into national law by the signatory states.

Currently, Article 17 of the Cartagena Protocol requires signatory states to notify the Secretariat and all affected or potentially affected states (parties and non-parties) of any event under their jurisdiction that leads or may lead to unintentional transboundary spread of living modified organisms (i.e. genetically modified organisms and thus also gene drive organisms). The EU Regulation 1946/2003, which implements the protocol, also requires this. It requires EU member states to prevent the unintentional transboundary spread of GMOs. The EU thus goes further than the provisions of the Cartagena Protocol, which only provide for the beginning of mutual consultation in such a case.

At its ninth meeting, the Conference of the Members of the Cartagena Protocol (COP-MOP9) recognised in paragraph 3 the possible negative effects of gene drive organisms on the environment. This decision confirmed that before releasing such organisms into the environment, it is necessary to consider whether research and (risk) assessment is necessary and whether specific guidance on this might be helpful in order to carry out case-specific risk assessment. International cooperation, knowledge exchange and capacity building should be used to better assess the potential adverse effects of gene drive organisms. At their tenth meeting in 2020, the member parties of the Protocol will now discuss whether to develop guidelines on gene drive organisms.

The Nagoya-Kuala Lumpur Additional Protocol on Liability and Compensation is a sub-protocol of the Cartagena Protocol on Biosafety. It entered into force in 2018 and has 46 signatories, including 21 EU member states and the EU. The Protocol provides for liability rules in cases of non-compliance with the provisions of the Cartagena Protocol. Like the Cartagena Protocol itself, this additional protocol applies to gene drive organisms. However, there are currently no specific provisions tailored to gene drives.

According to Article 3 of the Protocol, liability and compensation provisions apply when damage results from the transboundary movement of living modified organisms (LMOs), i.e. genetically modified organisms, whether introduced into the environment intentionally, unintentionally or illegally. According to Article 2, damage is defined as negative effects on the conservation and sustainment of biodiversity.

Article 2 also states that response measures can only be taken if the damage is measurable, observable and significant. The significance of the damage is measured by the following criteria:

• whether long-term or permanent changes have taken place that cannot be remedied by natural recovery within a reasonable period of time,
• the extent of qualitative or quantitative changes that adversely affect the components of biological diversity,
• whether the capacity of biodiversity to provide goods or services has been reduced,
• the magnitude of the adverse effects on human health.

However, that the Protocol provides no financial guarantees or other enforcement mechanisms is problematic.

In May 2021, an expert group established under the umbrella of the World Health Organization (WHO) published a guidance framework for the testing genetically modified mosquitoes including gene drive mosquitoes. They recommend a phased testing approach from lab trials to field trials and take a rather optimistic stance on the possibility to contain the spread of gene drive organisms in space and time through scientific progress.”

The Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction prohibits the development, production and stockpiling of biological weapons for military use. The Convention was adopted by the member states of the United Nations in 1971 and entered into force in 1975. 183 states have signed the convention and thus undertake to destroy all stocks of biological weapons. However, there are no agreements on controls in this regard, nor have disclosure obligations and controls been integrated by means of an additional protocol.

According to Article 1 of the Biological Weapons Convention, gene drives are prohibited if they are used for hostile purposes. This would also be the case, for example, if they were used to release toxins or pathogens. Similarly, any use of gene drives is prohibited if there is no justification for their use for peaceful purposes or if they are otherwise incompatible with the objectives and provisions of the UN Biological Weapons Convention ³.

At present, however, there are few convincing scenarios for gene drive weapon programs as gene drives and their harmful effects cannot be limited in space or time ⁴.