International and national biosafety regulations are urgently needed, including the right to say no

By Sabrina Masinjila, African Centre for Biodiversity (ACB) research and advocacy officer

Masinjila can be seen making a statement on behalf of the Convention of Biological Diversity Alliance (CBDA), calling for Parties to support the ongoing work of the Multidisciplinary Ad hoc Technical Expert Group (MAHTEG) on Synthetic Biology

The ACB has been monitoring the key issues under the Convention on Biological Diversity (CBD), including Synthetic Biology and gene drives, and their impacts on the African continent, over the past decade. Masinjila is attending the 26th meeting of the Subsidiary Body on Scientific and Technological Advice (SBSTTA 26) under the CBD, being held in Nairobi, Kenya from 13-18 May 2024, where Parties are convening to discuss Risk Assessment for genetically engineered (GE) gene drive mosquitoes. In this blog, she discusses the expansion of gene drive mosquito projects in Africa and the need for international and national biosafety regulations.

Gene drives are an extreme form of the genetic engineering package of synthetic biology techniques.1 They are ‘mutagenic chain reactions’ designed to spread throughout a population and override Mendelian inheritance patterns.2 In this context, a single trait introduced at one time could spread through an entire species, leading to that species becoming altered for a long period in an unknown way, or becoming extinct. Discussions on gene drive mosquitoes under the CBD have been extremely contentious, as those with vested interests have been blocking international regulation for these technologies.

In Africa, efforts to deploy gene-drive mosquitoes, particularly targeting malaria-carrying Anopheles mosquitoes, have been underway for some years, especially in West Africa, and are gaining traction recently in East Africa. Spearheaded by the Target Malaria Consortium – a collaboration between US, European and African research institutions, and backed by major funders such as the Bill and Melinda Gates Foundation and the Defense Advanced Research Projects Agency (DARPA), a research and development agency of the United States Department of Defense responsible for the development of emerging technologies for use by the military. Led by Imperial College London, in the UK, Target Malaria operates across several African countries, including Burkina Faso, Ghana and Uganda, adopting a phased approach involving first the release of transgenic mosquitoes as a precursor to eventual gene drive mosquitoes. The project has already released GM mosquitoes in Bana Village, Burkina Faso in July, 2019 in the face of numerous regulatory irregularities.

At present, Target Malaria is not the only gene drive entity operating on the African continent. It has been joined by Transmission Zero (T0), an international research programme dedicated to advancing gene drive technology.3 T0 collaborates with partners in Tanzania, including the Ifakara Health Institute (IHI) and the National Institute of Medical Research, along with researchers from Imperial College.4 Another project includes the University of California’s Malaria Initiative in Sao Tome and Principe, which actively promotes gene drive systems employing a phased approach.5

Strikingly, the gene drive projects are being rolled out in the absence of internationally agreed biosafety standards for risk assessment and management during the contained use experimental phase as well as for open releases. This is compounded by scant biosafety institutional and regulatory capacity and experience in Africa, and a shortage of timely information being shared in the public domain, as required by the Cartagena Protocol on Biosafety and national biosafety regulations. For example, civil society organisations (CSOs) who monitor GE in Tanzania were only made aware of gene drive experiments by way of an online consultation hosted by IHI three months ago, in February 2024, several years after the project had commenced.

This is contrary to the requirements for public awareness and consultations, as per Tanzania’s 2009 Biosafety Regulations, Section 21. CSOs have thus questioned the lack of publicly available key non-confidential business information documents submitted by IHI to the National Biosafety Focal Point, including import permits, applications to conduct experiments and risk assessment and management plans, as required under national biosafety regulations. Furthermore, while these documents are important, the regulations do not address risk assessment and management of gene drive organisms. This is because national biosafety regulations are based on international biosafety regulations and best practices. If these are not in place at the international level, and with a lack of updated national regulations, it will be impossible to deal with the advent of new risky technologies.

The need for regulation of gene drive mosquitoes 

Process for gene drive regulation under the CBD

At the international level, and under the auspices of the CBD and Biosafety Protocol, there is lack of internationally recognised biosafety risk assessment and management for gene drive organisms. CSOs supported by several Parties were unsuccessful in their campaign for a moratorium on the release of gene drive organisms at the 14th Conference of the Parties (COP 14) held in Sharm El Sheikh, Egypt.6 However, a process for the development of guidance protocols on risk assessment for engineered gene drives was agreed upon7, with an Ad hoc Technical Expert Group (AHTEG) for Risk Assessment established under the auspices of the CBD.8 9

To date, draft guidance10 has been developed, which provides a concrete starting point to fill the current international law lacuna but much work still lies ahead. Further guidance is needed, for example, that provides thorough methodologies capable of fully tackling and addressing the risks and uncertainties linked to gene drive organisms.

While further guidance is needed, we also stress that the right to say no must also be dealt with, given that there is no guarantee that such methodologies will address uncertainties about gene drives because monitoring is of little use for a technology that lacks foolproof mitigation strategies. Therefore, it also calls into question whether risk assessment guidance will be sufficient for dealing with risky technologies such as gene drives.

SBSTTA addresses Synthetic Biology broadly, which also covers gene drives. In 2018, the CBD’s COP 14, under Decision 14/19,11 agreed that broad and regular horizon scanning, monitoring and assessing of the most recent technological developments is needed. At the 15th meeting, the COP adopted Decision 15/31, 12 which established the process of broad and horizon scanning and the establishment of a Multidisciplinary Ad hoc Technical Expert Group (MAHTEG) on Synthetic Biology to support this process, which undertook its work in 2023-24.13 This process identified emerging trends, including the development of engineered gene drives for disease and invasive species control. The MAHTEG acknowledges the need for systemic alternatives to address health challenges and the need to develop additional and more comprehensive holistic guidance to address the transboundary movement of gene drives, risk assessment and management, socioeconomic and ethical factors, and engagement with indigenous peoples, among others. This illustrates the huge chasm between international and national biosafety regulation for gene drive organisms, the risks posed and the pace at which these technologies are being foisted on Africa.

Photo credit: Bioversity International/M.Elias

The MAHTEG report corroborates the many concerns raised over the years concerning gene drive experiments, including the lack of data necessary for predicting the potential efficacy of gene drive technologies. We strongly urge African governments, where gene drive mosquito projects are underway, to refrain from any releases of such organisms, taking into account the lack of holistic international and national biosafety regulatory measures, based on the precautionary principle and the right to say no. While we acknowledge that malaria is a huge public health challenge in Africa, we believe that countries need to seek interventions that address the structural causes of malaria, such as the lack of water and sanitation, and strengthening public health systems. We continue to caution against the imposition of imperialist projects such as gene drives, which continue to divert attention and investment away from sovereign systemic solutions to combat health crises such as malaria.

Towards SBSTTA 26 and key issues for consideration for African governments 

The outcomes of the AHTEG on risk assessment in the development of voluntary guidance and the MAHTEG on Synthetic Biology will be up for discussion during SBSTTA 26 and are bound to continue to be fiercely contested.

The ACB calls upon African governments to support further work on the draft guidance materials for risk assessment on engineered gene drives including circumstances when the right to say no is justified. This will include establishing a new AHTEG that will work on the gaps that exist in the current guidance while ensuring that conflicts of interest are avoided in these expert groups. Such risk assessment should take into account the socio-economic, cultural, and ethical impacts of engineered gene drives as recommended in the draft guidance. We further urge governments to be accountable to the public through public awareness, education and participation, access to information and data availability, to ensure the timely and meaningful participation of indigenous people and local communities, based on their free, prior, and informed consent.

The ACB is supportive of the recommendations of the MAHTEG on Synthetic Biology for broad and regular horizon scanning, monitoring, and assessment, especially considerations related to engineered gene-drive organisms.

Specifically, we urge African governments to support the maintenance of broad and horizon scanning, monitoring and assessment of trends in synthetic biology and to ensure the continuation of this process. Further, Parties to the CBD should consider a regular process on a two-year intersessional cycle while maintaining the multidisciplinary nature of the technical expert group.

You can read Masinjila’s article in the CBDA online newsletter, Eco, here.

Related work

Click here for reflections from ACB’s attendance of SBSTTA 25.

In the lead up to COP 15, where the Post-2020 Global Biodiversity Framework was to be finalised, ACB’s Mariam Mayet and Sabrina Masinjila reflected on the proceedings on biosafety and new technologies in this blog.

In a 2019 video produced by the ACB, network partners explain why they are opposed to any form of rollout of GM and gene drive mosquitoes

Here is the EN version.

Here is the FR version.

End Notes






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