This report analyses the security implications of the developments that have taken place in recent decades in the fields of genomics, genetic engineering and synthetic biology. The relevant international regulatory frameworks need to be enhanced to keep pace with biotechnological advances, while a whole-of-society approach appears to be the best way to deal with the pressing ethical issues that biotechnology raises.
This report focuses on the security implications that have arisen as a result of developments in biotechnology in recent decades.
To set the scene, we first look at the rapid advances in genetic-modification technology since the 1970s; the development of synthetic biology since 2000; the research related to genetic engineering, which has brought about technological innovation since 2000; and the innovative aspects of genome-editing technology (CRISPR/Cas9), which first appeared in 2012. We discuss the positive and negative aspects of these technologies, and in particular the importance of advanced life-science technologies from the perspective of risk–benefit analysis and biosecurity.
The ability to understand, recreate and manipulate the basic building blocks of life is driving the growth of the bioeconomy. This includes the commercialisation of biological processes, such as modifying living organisms to perform additional or enhanced functions. Biotechnology is becoming increasingly important for national economic security and competitiveness in global markets; countries are therefore vying for leadership in all of its fields, including its medical, agricultural and environmental applications. The United States, China, the European Union and Japan, among others, have been issuing strategic documents on biotechnology and incorporating it into their economic-security strategies.
Biotechnology has made it possible to manipulate genetic material for medicinal and agricultural purposes, and the opportunities for novel applications have grown exponentially. These ongoing innovations are having a profound impact on health, industry and the environment. But as the manipulation of genetic material becomes more widespread, the risk of accidental release of harmful organisms increases, as does the likelihood of unintended side effects.
The safety and reliability of genome editing are not technically guaranteed, and the ability to manipulate and modify life at the genomic level has led to growing concerns about the impact of editing the human genome. Such concerns are further heightened by the increasing convergence of biotechnology and artificial intelligence. There are also concerns that the expansion of gene editing could lead to eugenic practices, and about the potential knock-on effects for the offspring of people with edited human genomes. Although no country has yet approved the genome editing of fertilised human embryos, genome editing is currently being tested in laboratories worldwide.
Furthermore, consumer genetic-testing and genome-analysis services are becoming more widely available as providers are increasingly adopting the direct-to-consumer (DTC) model. However, many of these services are often carried out without the involvement of medical specialists, arousing concerns that decisions will be made without a scientific basis, potentially leading to misdiagnoses or inappropriate use. In the US, law-enforcement agencies have also used DTC genomic data to identify suspects in criminal investigations, possibly violating the terms and conditions for the use of personal data. There is an argument, however, that the perceived public good should supersede privacy interests, which would allow courts to accept DTC genomic data in law-enforcement investigations and legal cases.
Though advances in biotechnology create the potential for breakthroughs in medicine, agriculture, environmental management and industry, they also bring risks and ethical dilemmas. In particular, there are concerns that synthetic biology could be used for malicious purposes, such as the production of biological weapons. There is also a risk of accidental release of synthetic organisms, even in controlled laboratory environments. If these organisms spread uncontrollably, they could pose serious threats to public health and the environment. Continued advances in synthetic biology have therefore only fuelled the growing demand for a robust international regulatory framework to manage these risks and prevent misuse.
At present, the multilateral legal framework for preventing biotechnology from having an adverse impact on international security includes the Biological Weapons Convention (BWC), signed by 187 states, and UN Security Council Resolution 1540. However, within these frameworks there has been no agreement on a verification system to ensure countries are implementing the BWC, or on a mechanism for more in-depth monitoring. Also, because every country has a different stance on biotechnology, based on their culture and ethical values, there is no consensus on what degree of regulation to adopt. It is therefore difficult to formulate globally accepted guidelines. International organisations such as the World Health Organization and European Molecular Biology Laboratory are advocating careful regulation, transparency, and ongoing public dialogue to encourage the responsible use of genome-editing technology and to ensure it is developed with ethical foresight.
The challenge in regulating emerging technologies lies in the need to constantly expand the scope of governance. In the case of biotechnology, because there are multiple areas of concern – including biosafety, ecology, distributive justice, national security and the impact on climate change – the governance challenge is to incorporate interdisciplinary and multi-sectoral perspectives, and to build a whole-of-society approach.