The recent successive infectious disease outbreaks (West Nile virus in North America, Chikungunya virus in the Indian Ocean, Ebola virus in West Africa, and Zika virus in America) and the concomitant fear of bioterrorism have stimulated a growing reinforcement of biosecurity and biodefence measures. At present, policy focuses mainly on pathogens and toxins, while the focus is limited to fast-changing (bio)technologies with the potential to contribute positively to biological defence or to introduce unknown or unacceptable security risks. New financiers and professionals in biology enable the convergence of scientific disciplines and the implementation of new scientific approaches leading to emerging research areas such as synthetic biology, bioprinting or genome editing. Comprehending the overall landscape of biosecurity policies, relationships between policies and their interactions, and ways of exploiting advances in science and technology to enhance defence capabilities is crucial to ensure that policies address long-term gaps and challenges. Currently there is a significant dichotomy of the policy landscape for countering biological threats, with one grouping of policies focusing on prevention of theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies (ie, biosecurity) and another group on development of capabilities and knowledge to assess, detect, monitor, respond to, and attribute biological threats (ie, biodefense).
The fast pace of transformation within the bio sciences and biotechnology is simultaneously presenting new opportunities for building technological capabilities and for enhancing security vulnerabilities[1-3]. Four primary changes have occurred during the last decade that will continue to shape the biotechnology landscape:
Increasing convergence of physical, computational, materials, and life sciences. The convergence of life-science and non-life-science disciplines are leading to new scientific discoveries, capabilities, and applications. In some ways, this convergence involves the support for and conduct of cross-disciplinary science such as data science and the life sciences, which has enabled the fields of systems biology and precision medicine, or material science and the life sciences, which has led to additive biomanufacturing.
Expansion of practitioners of biology to include non-life scientists and engineers. The population of professionals who work with biological organisms and molecules has expanded well beyond the interdisciplinary life scientists and clinicians to include researchers with expertise in engineering, computer-, materials-, physical- and chemical sciences. The inflow of non-life science practitioners into biology has pushed the boundaries of scientific achievement and risk. While enabling innovation and entrepreneurship in biology and biotechnology, it may also create new vulnerabilities resulting from careless or malevolent individuals.
Globalization of biotech investments. Global investment in biotechnology and life sciences has increased because of the following reasons: a. growing national interest in addressing human health needs and improving agriculture and food availability/quality; b. international interest in building competencies to prevent, detect, and treat communicable and non-communicable disease. The global biotechnology market size was valued at USD 390.1 billion in 2017 with the largest market share in North America followed by Europe and the Asia Pacific region .
The funding landscape for research has expanded well beyond government funders, private industry and disease-specific non-profit organizations to include cross-over venture capital firms, foreign governments, and the public through crowdsourcing platforms. The change in the funding landscape enables innovation and entrepreneurship within the amateur and professional science and technology communities.
Since the elucidation of the flow of genetic information within a biological system (central dogma of molecular biology), scientists have made efforts to develop new technologies to modify or manipulate the genome, known as genome editing (GE). GE is a set of technologies that allow to change the DNA of an organism. These technologies make it possible to add, remove, or alter genetic material at particular locations in the genome and enables new discoveries about how microbes, humans, animals, and plants work. The intentional or accidental misuse of genome editing has been considered a potential risk[5, 6]. Several approaches to genome editing have been developed. A recently developed and particularly high-potential one is known as CRISPR-Cas9. Precise editing and regulation of genomic information is important to understanding the gene function. During the past decade, some technological breakthroughs have enhanced significantly the capabilities for genome editing and regulation.
Consequently, the threat spectrum can be expanded to include new possibilities for disruption or manipulation of biological systems and processes in humans, plants and animals, in addition to future threats from edited pathogens. The range of potential vectors, targets and effects will grow fast as genome editing becomes available for research and exploitation of biology. Genome editing potentially can be used to develop new biological weapons, including those that can affect the microbiome and the immune and nervous systems. The diversity, flexibility and accuracy offered by new genome editing techniques, such as CRISPR does increase the target range, which comprises the number, accessibility and severity of vulnerabilities that could be used to cause damage, either maliciously or accidentally .
Bacterial genomes encode the biosynthetic potential to produce hundreds of thousands of complex molecules with a multitude of applications, from medicine to agriculture and materials. Economic access to the potential encoded in sequenced genomes promises to revive dwindling drug discovery portfolios and open new avenues for the development of complex chemicals. Achievements in synthetic biology deal with these topics, which include DNA construction technologies, genetic parts for precision expression control, synthetic regulatory circuits, computer aided design, and multiplexed genome engineering. Together, these technologies are moving into a time when chemicals are available on a massive scale solely on the basis of sequence information. This enables the use of metagenomic data and massive strain banks for high-throughput molecular discovery and consequently the ability to route design pathways to sophisticated chemicals not found in nature.
Concepts, approaches and tools of Synthetic Biology do not in themselves represent immanent damage. Instead, there is concern about the specific applications or capabilities that synthetic biology could provide [8, 9]. Among the capabilities that currently justify the highest relative level of concern are the re-creation of known pathogenic viruses, the production of biochemical compounds through in-situ synthesis, and the use of synthetic biology to enhance the threat to existing bacteria . Capabilities of this kind are predicated on techniques and know-how easily accessible to a wide range of actors. Among the capabilities that present a medium to severe concern are the production of chemicals or biochemicals using natural metabolic pathways and the utilisation of synthetic biology to make existing pathogenic viruses more harmful. In the age of Synthetic Biology, with the advances in technological capabilities that have been made to this point, biotechnology represents a “dual-use dilemma” insofar as research findings, resources and methods that are necessary for beneficial R&D could be exploited to inflict damage.
The policy area for countering biological threats is divided into two basic groups: a biosecurity group, which specifically focuses on preventing theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, and technologies to cause harm; and a biodefence group, which involves the development of capabilities and knowledge-based to assess, detect and monitor, treat (or vaccinate against), and respond to biological threats . The two-group system has resulted from the dynamic and iterative process of biosecurity and biodefense policymaking during the past decades . Both groups often affect the same stakeholders, which result in mutual benefits among defence-oriented policies, but also may present barriers to achieving defence and security objectives
It is increasingly acknowledged that there is a need for a broader stakeholder engagement in the assessment, management and communication of biosecurity related issues . Stakeholders in the field of genome editing and synthetic biology encompass a broader range of actors than those involved in previous biosecurity dialogues. Therefore, the engagement of new actors is needed, especially those who can play an important role in the prevention or control of abuse. As emerging technologies such as genome editing, and synthetic biology continues to become more available, technological developers will have increasingly important governance roles . The fast-paced security landscape and the variety of stakeholders will also mean that governance measures for such new technologies will not be able to take a holistic approach. Instead, governance measures need to be adapted according to the application, the nature of the relevant stakeholders, and the type of abuse. Furthermore, given the need to facilitate knowledge sharing between stakeholders with different norms and values for effective biosecurity governance, stakeholder mapping could be a valuable tool for improving biosecurity.
We tend to look at the future of innovation in terms of intellectual property issues and regulatory policy, and how aggressive the enforcement of antitrust should be. By and large, such questions lead to debates about which government policies best promote innovation – assuming that innovation is beneficial, and that the government is generally in the position of a mediator between competing market participants. However, limiting the discourse on the future of innovation to the relations between innovators ignores the links between innovators and the government itself. This is because the government has unique stakes in the innovation process both as a large consumer of products in general and because it has a unique societal responsibility. First and foremost, security is one of them. Aside from the question of ownership of the rights to certain innovations, the government has an interest in who develops what – at least in so far as some innovations have a considerable potential for misuse, offence, destruction and havoc. Technologies, that place mass destructive force that is traditionally confined to states in the hands of small groups and individuals have proliferated remarkably widely . This proliferation is accelerating with astounding pace on a number of technological platforms – most prominently in biotechnology.