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The precautionary principle and the development of gene drive technology

08 April 2021
RECIPES Precaution Innovation

A malaria mosquito. Picture: Nechaevkon/Shutterstock

Een malariamug op de huid

When uncertainty exists about the occurrence of potentially serious risks in innovative products, precaution must be applied. This is how the precautionary principle is put into practice. But what does the application of precaution mean for innovation? In this series of articles on the precautionary principle, we provide insight into what is involved in applying the precautionary principle. In this article, we look at the role of the precautionary principle in gene drive technology.

In short:

  • Gene drive technology provides a way to rapidly, and permanently, genetically modify wild animals or plants.
  • This technology may have the potential to solve major societal problems in the fields of ecology, health and agriculture. It also comes with new, uncertain and unfamiliar risks.
  • Applying the precautionary principle in the development of gene drives is important. It can ensure that the interests of all stakeholders and future generations are taken into account.

Generally, it takes a long time for a genetic change in a plant or animal to spread through an entire population, because a gene is only inherited by half of the offspring. A gene drive increases the odds of inheriting a trait to nearly 100%. It is a genetic element that influences the probability of inheritance to its own advantage. In this way, the genetic characteristics of a population can change rapidly and permanently. A gene drive is a phenomenon that occurs in nature. The introduction of the cheap and fast genome modification technique CRISPR-cas9 has made it considerably easier to make synthetic gene drives.

Gene drive technology offers new and unprecedented possibilities to modify nature. Gene drive researchers and developers regard gene drives as the solution to pressing problems in the fields of public health, ecology and agriculture. Opponents, however, speak of an extinction technology, of which the development should be stopped. The possibilities and risks of a gene drive become apparent in one of its most cited applications: in the fight against malaria.

Applications of gene drives

By means of a gene drive, it may be possible to genetically modify mosquitoes so that they can no longer act as a host for the malaria parasite, thus preventing its transmission to humans. Another possibility that is researched is the creation of a drive that makes female mosquitoes infertile. The mosquito population responsible for transmitting the malaria parasite could then eventually die out. There is great benefit to be gained from the application of a gene drive. It could lead to the elimination of one of the most common infectious diseases that still claims many lives each year. On the other hand, the technology could potentially wipe out an entire species. There are large differences in how acceptable people find it to use a gene drive to achieve such a goal.

Complex questions

It is not certain whether using gene drives is the best method to tackle the aforementioned challenges. There are doubts among both scientists and critics about the technical feasibility of gene drives. Scientists question the ability of gene drives to overcome the complexity of our ecosystem. Amongst others, questions have arisen concerning  the stability of modified organisms in the wild. In addition, there is much uncertainty about the dangers, risks and consequences of deploying a gene drive.

The effects of a gene drive are not easily confined to a particular country, as animals or plants can cross borders without hindrance. This creates an additional layer of complexity. It makes regulation and decision-making on the application of the technology difficult, and it could even lead to political conflicts. What if one country agrees to deploy a gene drive, but the neighbouring country does not? At this moment, it is not possible to keep modified organisms within a national boundary. There are several unresolved issues, including: who should be involved in deciding whether or not to use gene drives? In which cases should the technology be applied? And which interests should be taken into account, and to what extent?

In earlier articles we wrote that, in the case of uncertainty about serious risks of new technologies, precaution must be exercised. This is also important in the case of gene drives.


This article is based on one of the ten case studies in the RECIPES project. The purpose of these case studies is to gain more insight into the controversies and complexities involved in applying the precautionary principle to various innovations

The results of the RECIPES project will allow the EU to remain at the forefront of science by re-examining the precautionary principle in relation to innovation and major societal challenges. The project started in January 2019 and will last for three years, with an extension of six months. Eleven organisations from seven European countries are working together on the RECIPES project. The initiator of this consortium is the Faculty of Law at Maastricht University.

The risk of gene drives

The risks of gene drives depend on the animal or plant that is modified, the environment and the genetic alteration that is made. This makes it difficult to assess and estimate the risks. Roughly speaking there are risks in the fields of environment, health and regulation. Gene drives have the ability to spread independently through a wild animal or plant population, and to cause a lasting change. This is the greatest risk of the technology. It is also the reason why some see the technology as a game changer in genetic modification techniques.

Scientific uncertainty

Application of gene drives may involve major risks. However, there is scientific uncertainty about the likelihood of these risks, which is caused by several factors.

Applying the precautionary principle in gene drive research

How should we deal with precaution in relation to the development and application of gene drives? Researchers, policymakers and other parties involved do not disagree on whether precaution should be exercised. However, there are various ways in which those involved (wish to) implement the precautionary principle. For example, there are opponents of gene drives. These include the approximately 170 civil society organisations that, a few years ago, collectively called for a total ban (moratorium) on further development of the technology because they consider its dangers too great.

This strict interpretation of precaution is met with resistance from some researchers and stakeholders of the technology. They argue that it is unethical not to research gene drives, given their social promise. They advocate a broader interpretation of the precautionary principle. They propose a modified risk assessment, in which research into gene drives is allowed under certain conditions. Ultimately, the request for a moratorium at the UN Convention for Biodiversity in 2018 was not granted. However, it was decided that an extensive risk assessment is necessary, in which the risks for humans, animals and the environment are examined for each application.

The importance of further dialogue

Presently, the application of the precautionary principle has not led to a ban on the development of gene drives. Since the technology alters a shared environment, consequences of the deployment  affect everyone. It is important that researchers, policymakers and representatives of society enter into dialogue, and discuss how the development of gene drives can be guided by values that are important to society. The precautionary principle can play a role in this, as we suggested in an earlier article. Its application can help to determine where the boundaries lie for the use of this technology. Who decides on those, and who bears the responsibility for the application of precautionary principle and the consequences of the technology? Are there alternatives to gene drives and how do they relate to this technology? Applying the precautionary principle can also help to take into account the interests of future generations. In this respect, it is important that the focus of applying precaution is not on the final assessment of the risks, but that the application of precaution is considered early on in the research process.

Gene drive researchers are already doing this to some extent. Recently, researchers from various disciplines published a document with rules they adhere to regarding safety measures for lab and field studies. The document also contains suggestions for regulation of the technology. Given that gene drives can have large-scale effects, it is important that the application of precaution is not left solely to the developers of the technology, but that the discussion about it is broadened.

Gene drives offer new and unprecedented opportunities to intervene in nature. An earlier case study for the RECIPES project demonstrated that it is important to discuss the desirability of a technology in parallel with its development. By applying the precautionary principle early on, it can steer innovation in the right direction. In this way, the principle does not become a barrier to technological progress. But it serves as a compass to steer innovation in the direction of society's interests and needs.