Seminar and Press Conference on Gene Drives in Nairobi

This morning, Friday 17th of May, Save Our Seeds with Pollinis hosted a hybrid seminar on GMOs and gene drives. This event offered an exceptional opportunity to gain insights into the political landscape surrounding GMOs and the increasingly contentious topic of gene drives currently under consideration at the United Nations Convention on Biological Diversity. Our expert speakers, fresh from the recent SBSTTA discussions, shed light on what transpired during those crucial debates and what it means for local contexts.

Following the seminar we hosted a press conference attended by journalists from several African countries.

Press Release

UN Body Considers Risky New Genetic Technologies: Civil Society Urges Precaution

Nairobi, Kenya, May 17 2024: Parties to the United Nations Convention on Biological Diversity (CBD) are currently discussing controversial technologies in Nairobi.  One such technology is engineered gene drives. It is a form of extreme genetic engineering which is designed to spread its modification throughout an entire species and persist in the environment. In Africa, gene drive projects, largely funded by the Bill and Melinda Gates Foundation, are already underway in several countries including Burkina Faso, Ghana, Uganda and most recently in Tanzania, aiming to eradicate malaria. However, these techno-fixes do not address the root causes of health challenges on the continent and pose novel risks. Furthermore, these projects are proceeding despite the absence of adequate local capacity to assess and regulate them effectively.

While gene drive lobbyists, at the 26th meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) to the CBD in Nairobi,  use the possibility of malaria eradication to promote the technology, civil society organizations have found that most patents are being filed for agricultural use. Patents reference hundreds of agricultural uses, such as for herbicides, pesticides and so called “pests”. Researchers found that agribusiness firms such as Monsanto-Bayer and Cibus Bioscience were also engaging with gene drive development.

At this year’s SBSTTA meeting, member states are examining reports from expert groups, highlighting numerous risks and unanswered questions about gene drives. Discussions are particularly focused on the contrasting potential benefits and risks these technologies might pose. Sub-Saharan countries are advocating for enhanced capacity building, technology transfer, and some seem to be willing to adopt gene drives. African civil society organizations (CSOs) are calling for ongoing evaluations and a robust, updated regulatory framework to manage these technologies. They endorse a precautionary approach and support the establishment of an international expert group to review new technologies before they are introduced to the environment.

Decisions made at SBSTTA will be taken to the Conference of the Parties to the CBD in October 2024 to be further discussed, where heads of states will decide on how to proceed with these technologies.

Contacts: 

Sabrina Masinjila

African Centre for Biodiversity

+255 767 089 834

Barbara Ntambirweki

ETC Group Uganda

bntamby@gmail.com

References:

Gene Drive Brochure

https://www.stop-genedrives.eu/wp-content/uploads/2021/06/GeneDriveOrganisms_-A-New-Dimension-of-Genetic-Engineering_210615.pdf

Forcing the Farm:

https://www.etcgroup.org/content/forcing-farm

by stopgenedrives

SBSTTA 26: Urgent need for international biosafety oversight and the right to say no, as gene drive mosquito projects expand in Africa

As participants in the 26th Subsidiary Body on Scientific, Technical, and Technological Advice (SBSTTA 26) of the UN Convention on Biological Diversity (CBD), we will be sharing insights through articles authored by members of the CBD-Alliance’s Working Group on Synthetic Biology, to which we belong.

Key topics of discussion at the Nairobi conference include synthetic biology and the risk assessment of gene drives. For more detailed information on the issues at play, we invite you to consult the briefings (short/long) we have developed in preparation for this conference.

Please find below an article by our partner Sabrina Masinjila from the African Centre for Biodiversity:

Urgent need for international biosafety oversight and the right to say no, as gene drive
mosquito projects expand in Africa

Gene drives, a form of synthetic biology, pose significant risks with their potential to alter entire species, including driving them to extinction. Discussions on gene drives under the Convention of Biological Diversity (CBD) have been extremely contentious, as those with vested interests have been blocking international biosafety regulation and oversight.

Projects like Target Malaria and Transmission Zero (T0) are advancing the deployment of gene-drive mosquitoes, primarily targeting malaria-carrying Anopheles mosquitoes, in both West and East African countries. However, these initiatives have proceeded in the absence of internationally agreed biosafety standards to govern risk assessment and management during the contained use experimental phase as well as open releases.

This is compounded by scant biosafety institutional and regulatory capacity in Africa, a lack of regulatory experience, and no transparency in terms of information, as required by the Cartagena Protocol on Biosafety and national biosafety regulations.

African civil society in Tanzania, for example, where the T0 project operates, have raised concerns about limited wider public consultation and access to pertinent documents.

While malaria is a huge public health challenge in Africa, investments should focus on systemic solutions that provide adequate healthcare, clean water, and sanitation.

Please see ACB’s new blog for more detail: https://acbio.org.za/gm-biosafety/expansion-of-gene-drive-mosquito-projects-in-africa/

Gene drive organisms pose unacceptable risks to biodiversity and human health and the draft guidance for risk assessment developed under the CBD to date is not comprehensive enough to address the uncertainties. Further guidance that invokes the precautionary principle and the right to say no is essential. We strongly urge African governments to support further guidance under the CBD that provides thorough methodologies capable of fully addressing the risks.

by stopgenedrives

The need for horizon scanning and technology assessment to address the evolving nature of genetic engineering

This is an excerpt of a Briefing Paper by Third World Network published in June 2022

Introduction

The governance and regulation of advancing life and agricultural sciences is lagging behind technical innovations and our evolving understanding of the science underpinning genetic engineering technologies. Such technologies, mainly in the form of transgenic techniques, were first commercialized nearly three decades ago, though few traits have reached the market. With advances in science and technology, the field is attempting to explore new genetic engineering techniques that can expand the scope, applicability and depth of intervention.

New genetic engineering techniques, however, are evolving beyond the current scope of legal definitions, risk governance and consent mechanisms, with interventions increasingly moving towards ecosystem-wide projects for crop, human health and climate or biodiversity conservation interventions (Greiter et al., 2022; Heinemann, 2019; Sirinathsinghji, 2019). Such advances at the technical level are raising novel biosafety risks that urgently warrant updated assessment methodologies and regulations to address significant biosafety knowledge gaps and increasing levels of uncertainty about how these technologies will impact biodiversity and human health.

Moreover, thorough scrutiny of their potential limitations to alleviate the societal problems they are purported to address, and which existing living modified organisms (LMOs) have not been able to combat, is also needed. Indeed, many of the original concerns raised about LMO commercialization have been borne out, including efficacy problems and unintended agronomic and ecological effects resulting in repeated crop failures and economic damage, particularly for smallholder farmers (for example, see ENSSER, 2021; Kranthi & Stone, 2020; Luna & Dowd-Uribe, 2020; Wilson, 2021). While new technologies are being developed to address the problems that first-generation LMOs failed to solve, proponents are again hyping up the potential benefits and making blanket claims about safety.

In this context, it is imperative that horizon scanning and technology assessment are fully operationalized to protect biodiversity and human health from the new genetic engineering technologies, including synthetic biology, that are yet to be fully understood, and currently difficult, if not impossible, to control, reverse or recall from the environment following release.

(....)

Gene drive technologies

Gene drive technologies are a form of genetic engineering designed to skew inheritance of the engineered trait such that most, if not all, offspring will inherit the trait, with the aim of rapidly “driving” it through a population. Various applications have been proposed, with the most advanced and promoted being gene drive mosquitoes that aim to reduce vector-borne disease burden, such as malaria or dengue fever. The Target Malaria project aims to use gene drives to eliminate mosquito populations (population suppression) by spreading infertility or gender-bias traits, while other projects aim to alter transmission (population modification) of disease pathogens to humans. Agricultural applications such as the elimination of pests, as well as conservation applications such as the elimination of invasive species, are also envisaged (CSS et al., 2019).

Various molecular mechanisms are being deployed to achieve the driving characteristic, the most common being the use of genome editing technologies such as CRISPR systems. These are incorporated into the gene drive organism in order to carry out genetic engineering “live” inside wild organisms, “cutting and
pasting” transgenic DNA at each generation for perpetuity. Described as transferring the laboratory to the field (Simon et al., 2018), rather than the genetic engineering being performed in the laboratory where, in theory, it can be assessed for biosafety concerns, the continuing engineering process means that any
unintended effect cannot be ruled out prior to release.

Unintended effects at the molecular level have been widely documented with genome editing techniques such as those deployed for gene drives. These include on-target and off-target effects, novel protein production and cellular impacts (e.g., see Agapito-Tenfen et al., 2018; Biswas et al., 2020; Brunner et al., 2019; GeneWatch UK, 2021; Ihry et al., 2018; Kawall, 2019; Norris et al., 2020; Ono et al., 2019; Skryabin et al., 2020; Tuladhar et al., 2019), with next-generation effects (Zhang et al., 2018). These unintended effects may continue to occur or accumulate following release, and spread with unknown consequences with regard to their interaction with the environment, pathogens or humans who may be exposed to gene drive organisms and any pathogen within them. The evolutionary impacts of such nextgeneration effects are completely unknown, and raise novel challenges to risk assessment methodologies, as concluded by the Cartagena Protocol on Biosafety’s Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management (AHTEG, 2020).

Unlike existing LMOs, gene drives are designed to spread and persist. The ecological consequences of this are unknown, for example any potential impacts on the target organism’s wider food webs, or non-target organisms that are connected via gene flow to the target organism itself. Ecological effects may take decades to become visible, and are notoriously difficult to study. Using gene drives to remove invasive species can have unexpected detrimental effects if functional roles within ecosystems have been embedded (Lim & Traavik, 2007; Sirinathsinghji, 2020). Such interventions also introduce the risk that they may spread to the target organism within its native range, with potentially serious ecological harm.

Discussions around disease applications have also not given sufficient consideration to potential negative impacts on disease epidemiology. How any unintended or intended effect may impact on disease transmission is unknown and difficult to assess prior to release (Beisel & Boëte, 2013; Sirinathsinghji, 2020). For example, how the modifications may alter disease transmission, or pathogenicity of the target (or non-target) pathogen, particularly with population modification drives that will exert pressure on the pathogens to evolve around the modified trait. Most crucially, such risks, as partially acknowledged by developers (James et al., 2020), cannot be comprehensively assessed in the lab. Moreover, the capacity for vectors to transmit disease is mediated by wider environmental factors, e.g., bacterial symbionts in mosquitoes. How the genetic engineering process impacts on these factors is highly uncertain. Further, whether gene drives will positively impact disease epidemiology, even if they are capable of reducing mosquito numbers, is still questionable.

Finally, gene drives are currently irreversible, and there are no existing strategies to recall, reverse or mitigate a gene drive release. While there are proposals to release mitigating drive systems in response to a gene drive going awry, these only add uncertainty and complexity, with research recently demonstrating unintended genetic effects with some techniques in laboratory flies (Xu et al., 2020). How different genetic elements interact once multiple systems are released into the environment, with continued development of novel gene drive systems, adds yet more uncertainty and complexity that warrant horizon scanning to continually monitor such developments. New developments are also taking place in bacterial systems with applications for addressing antibiotic resistance and bacterial infections, by taking advantage of the natural processes of horizontal gene transfer in bacteria. These developments have thus far garnered little attention but require further monitoring.

Technology assessment that incorporates not only biosafety, but also suitability, ethical and political considerations, is needed. Issues around consent, particularly in obtaining the free, prior and informed consent of potentially affected IPLCs, are critical and part of the broader discussions around gene drives. Social, political and commercial determinants of disease need to be taken into account when weighing up potential costs and benefits of gene drive applications. A narrow focus on vector control may risk marginalizing key health determinants such as strengthening healthcare systems, access to treatments, poverty alleviation and wider sanitation interventions, which should be incorporated into the technology assessment discussions.

(....)

Conclusion

Genetic engineering technologies and their applications are rapidly evolving. They are, however, being framed by proponents as safe, necessary or even as falling outside of LMO definitions, in various attempts to avoid the scrutiny required to protect against potential risks to biodiversity. Emerging techniques such as genome editing that are being applied to crops, gene drive technologies, genetically engineered viruses, HEGAAs and more, pose a plethora of risks and unintended effects, which are already notably acknowledged in biomedical fields (Burgio & Teboul, 2020; Ledford, 2020; National Academy of Medicine (U.S.) et al., 2020).

Nonetheless, proponents are intending to release these technologies into the environment, with explicit intent to increase the scale and levels of intervention beyond agroecosystems, directly into wild species and ecosystems. Reduction of genetic diversity, even at the level of a single gene, can impact food webs and ecosystems, such that even without unintended effects of the genetic engineering process itself, the impacts of altering genes in open settings are unpredictable, with potential adverse effects (Barbour et al.,2022). Genetic changes by human activity can bypass the processes of evolution for their establishment and spread in nature (Heinemann et al., 2021), raising new levels of uncertainty and risk. Moreover, this will occur in the context of fundamental knowledge gaps around how such interventions will interact with complex, wild ecosystems.

Gene drives, RNAi and genetically engineered viruses are just a few examples of some technologies on the horizon or already reaching markets. More applications, including of synthetic biology, and new genetic technologies are in the pipeline.

It is imperative that there is:

1. horizon scanning so that regulators and policy makers can keep abreast of the science, have information relevant for risk assessment and risk management, and thus be adequately prepared for whatever technologies are approaching; and
2. technology assessment so that these new technologies can be robustly assessed, not just for their environmental and human health impacts, but also for their social, cultural and ethical implications. The CBD, as the near-universal legally binding treaty governing biodiversity, must therefore include and operationalize horizon scanning and technology assessment, including in its post-2020 Global Biodiversity Framework.

by stopgenedrives

Interview with Lucile Cornet-Vernet

Gene Drives will most probably be released first to fight malaria. We therefore created this series of interviews with health care experts, researchers and civil society to amplify their voices and concerns around this technology.

How did you get to work on malaria and what are you doing?

Lucile Cornet-Vernet is the founder of “La Maison de l'Artemisia” (engl.: the house of artemisia) founded in 2012. After her friend, Alexandre Poussin, got severly sick from Malaria in Ethiopia and recovered due to a tea made from the artemisia plant she started on a one year research adventure, where she read through all the publications around artemisia and malaria, back then around 800, nowadays approximately 1500. She called doctors who worked with the plant and created a whole bibliography on the state of the art around artemisia curing malaria. She then decided to dedicate her entire work to that plant and created the first “Maison de l’Artémisia”, nowadays there are around 105 of them in 27 countries. They function as research and training centers, where especially vulnerable populations (low income or remote communities) get formations on how to grow, harvest and prepare the preventive or curative teas. 

What plants are you working with and what about emerging resistances to Artemisinin?

Before they achieved this, Lucile reached out to an agronomist and they worked on adapting the seeds that originally came from the high plateaus of China to the African regions. Artemisia has a high genetic diversity. Lucile managed well to adapt the seeds to different climates. 

Lucile works with two different plant varieties. The Artemisia afra and Artemisia annua. The second comes from China and has 23 different components against malaria. The first one is a bit less researched but has at least 10 components, contains no artemisinin and is a perennial bush, making it much easier for people to grow and sustain it. There has been some research published about the emergence of artemisinin resistance in south-east Asia. This does not threaten her project, says Lucile, seeing that artemisinin is only one component in the plant that fights the disease and that Artemisia afra for example does not even use that. Furthermore, this resistance has been observed for quite some time. Whereas in China, where Artemisia annua originally comes from and where the plant has been used over centuries (and is officially malaria-free since 2021) no resistance has been detected. Lucile furthermore describes the plants as “poli-therapeutical” due to their multiple anti-malarial components. That is more diverse than any drug on the market and makes it resistant to resistances. 

Why isn't the plant the mainstream solution to malaria then?

The biggest obstacle to her work is that they lack funding to do large scale clinical tests with the plants, conducted by uncontestable doctors, so that the plant could be mainstreamed as a solution. Lucile has initiated a consortium with a dozen world-renowned research organizations, such as Institut Pasteur. This consortium evaluates the efficacy of artemisia and would conduct randomized tests, when funding comes in. 

What makes malaria worse than most other diseases?

Lucile talks about the alarming effect malaria has on the whole continent. Apart from thousands of deaths that mostly hit the poorest, pregnant women and children, the disease creates a vicious cycle of poverty. Malaria can weaken people for a long time, which prevents farmers from sowing their seeds at the right point in time, mothers from selling their surplus on markets to generate an income or children from going to school. The world has set its mind on producing very cheap medicine against malaria, but families still have to afford the treatment, which in many cases is even wrongly produced and does not cure the people. 

Lucile gives the example of the DRC, where 60% of the budget from the health ministry is spent on malaria control, keeping the country trapped. 

What do you think about Gene Drives?

Regarding gene drives, Lucile does not see them as a solution. She has a quite clear stance against GMOs. She managed to adapt the Artemisia seeds to a whole continent, with different climates and ecosystems, without knocking in a gene for heat resistance. “Before doing something complicated, why not do it easy?” We can’t know what the effects of GDOs are, therefore she’d propose to rather work on the solutions we have at hand. Like the artemisia plant, that would give back the power to the people to treat themselves. The solution is effective, cheap, with a low carbon footprint and local. 

____

Further videos: https://youtu.be/xI_dKFhojhM 

The book published by Lucile: Artemisia | Actes Sud (actes-sud.fr)

--

These are the interviews on the topic held so far with the following experts:

Andreas Wulf, physician and expert for global health policy at Medico International in the Berlin office, provides his views on the role of the Bill & Melinda Gates Foundation in international health policy and his outlook on necessary conditions for the implementation of the human right to health in Africa.
Click here for the interview

Ali Tapsoba de Goamma, human rights activist, and spokesman for an alliance in Burkina Faso against the release of Gene Drive mosquitoes in his home country, on the malaria control measures implemented so far and the attitude of the local population towards the planned field trials with Gene Drive mosquitoes.
Click here for the interview

Pamela J. Weathers, professor and researcher at Worcester Polytechnic Institute in Massachusetts, USA, on the efficacy and controversial safety of Artemisia tea infusions for treating or preventing malaria.
Click here for the interview

Arnaud Nouvion, consultant La Maison de L’Artémisia, describes the potential benefits of the Artémisia plant and state that more funding is needed to conduct clinical studies, proving once and for all that the plant is a great tool in the fight against malaria.

Click here for the interview

More interviews to follow.

by stopgenedrives

IUCN debates the role of genetic engineering in nature conservation

Should nature conservationists back genetic engineering of wild species in order to counter the impact of human activity?

On Friday, 10.09.2021, the International Union for the Conservation of Nature, IUCN, at its World Congress adopted a resolution (Res. 075) at its General Assembly in Marseille, initiating a three-year position-finding process on the role of synthetic biology in relation to nature conservation. A draft resolution is to be developed and put to a vote by the next World Conservation Congress in 2024.

Applications to be discussed in this process include both the synthetic production of nature-identical products in the laboratory as well as proposals to control pests using genetic engineering in agriculture, or the genetic manipulation of insects for the purpose of disease control in open environmental systems. Most controversially, proponents and developers of genetic engineering processes even propose gene drivesas a means for nature conservation, e.g. for eradicating invasive species.

Provisions of IUCN Resolution 075 

Resolution 075, entitled "Development of an IUCN position on synthetic biology in relation to conservation" establishes an inclusive and participatory process within IUCN, with the aim of developing an IUCN position on the implications of the use of synthetic biology in conservation.  The resolution states that until this IUCN position is formally adopted, IUCN must remain neutral (e.g. in international fora such as the CBD) on all aspects of synthetic biology, even if new evidence emerges during the process.

By passing important amendments to Resolution 075, international conservation representatives in Marseille recognized that there exist major data and knowledge gaps as well as unsolved ethical, social, cultural and ecological issues around the technologies developed to genetically engineer wild species. Resolution 075 stipulates that these uncertainties necessitate the application of the precautionary principle and must be taken into consideration by any position the IUCN may decide to take on the topic. For this reason, particular attention in the IUCN's effort of collaborative knowledge building will be paid to identifying knowledge gaps, data deficiencies and scientific uncertainties that make it impossible to assess the impacts of existing and potential future applications of synthetic biology (including gene drives) in the context of nature conservation. In particular, open questions and challenges in ecological, conceptual, legal, socio-economic, cultural and ethical terms will be formulated and compiled. In this regard IUCN members also agreed to prioritize the perspectives, knowledge and rights of Indigenous people’s and local communities in their deliberations on these technologies during the coming 3 years.

Mareike Imken, co-ordinator of the European Stop Gene Drives campaign welcomes the IUCNs commitment to the precautionary principle and its intention to foster increased understanding and debate among its members around the use of genetic engineering technologies for nature conservation purposes.

“A broad and inclusive IUCN discussion process will be crucial to raise awareness among IUCN members that the tampering with natural evolutionary rules in the application of gene drive technology will bring about a new dimension of intervening with – and irreversibly changing - the natural world that IUCN itself means to preserve.”

The contentious negotiations around this resolution at IUCN World Congress in Marseille were divided between civil society groups calling for the IUCN to not endorse environmental releases of synthetic biology applications, and pro-gene drive proponents who advocated for synthetic biology, including gene drives, to be accepted as a tool for nature conservation. One of the gene drive proponents, IUCN member Island Conservation, advocates to use gene drives to eradicate invasive mice on islands.

Civil Society press release here

To the adopted IUCN Resolution 075 here

###

On synthetic biology

The umbrella term synthetic biology is used to describe genetic engineering techniques that rebuild, resynthesize, or alter biological components or natural processes in ways that do not occur naturally. Applications of synthetic biology can either be used exclusively in closed systems/laboratories, or also aim to use them in open natural systems, using genetic engineering to alter wild species and ecosystems - for example, via the controversial process of gene drives.

History of the motion process in the IUCN

With IUCN Resolution “WCC-2016-Res-086” adopted at its Members’ Assembly in Hawaii 2016, the IUCN was tasked to develop a policy on Synthetic Biology and Biodiversity Conservation for adoption by 2020. However, both IUCN members  and members of civil society organisations  criticised the way this plan was carried out. They pointed out that there currently is insufficient awareness among IUCN members about the fundamental questions that such an IUCN position would raise. In addition, the IUCN assessment report “Genetic Frontiers for Conservation” which was largely drafted by boosters of the technology was criticized to provide an insufficient basis for the vote on such a policy.

Civil Society Briefing for IUCN Delegates for IUCN World Congress in English here

Civil Society Briefing for IUCN Delegates for IUCN World Congress in French here

Civil Society Briefing for IUCN Delegates for IUCN World Congress in Spanish here

Civil Society press release on the Start of the IUCN World Congress 2021 from 4.09.2021 in English here

---

Recommended reading:

ETC Group 2019: A review of the evidence for bias and conflict of interest in the IUCN report on synthetic biology and gene drive organisms.

Testbiotech 2019: Testbiotech comment on the IUCN report “Genetic frontiers for conservation, an assessment of synthetic biology and biodiversity conservation.

ENSSER 2021: A critique of the IUCN report ‘Genetic Frontiers for Conservation’. An assessment An assessment of synthetic biology and biodiversity conservation’ – with regards to its assessment of gene drives

by stopgenedrives