Concept note of the International Bioethics Committee (IBC) on the ethical issues related to the acceleration of the development of synthetic biology

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• SHS/IBC-31/2024/2 Paris, 22 August 2024 Original: English 1
• CONCEPT NOTE OF THE INTERNATIONAL BIOETHICS COMMITTEE (IBC) ON THE ETHICAL ISSUES RELATED TO THE ACCELERATION OF THE DEVELOPMENT OF SYNTHETIC BIOLOGY 1
• Within the framework of its work programme for 2024-2025, IBC decided to address the topic of the ethics of synthetic biology. 1
• At the 30th Ordinary Session of IBC in September 2023, the Committee established a Working Group to develop an initial reflection on this topic. The IBC Working Group met online on several occasions between January and July 2024 to discuss the content and structure of their report, and the Working Group’s discussion was enriched by private online hearing sessions with prominent experts in the field. In preparation for the 31st Ordinary Session of IBC from 16 to 20 September 2024 at the UNESCO Headquarters in Paris, the IBC Working Group prepared a concept note providing a synopsis of its reflection so far. 1
• As it stands, this concept note does not necessarily represent the final opinion of IBC and it is subject to further discussion within the Committee in 2024 and 2025. This document also does not pretend to be exhaustive and does not necessarily represent the views of the Member States of UNESCO. 1
• ETHICAL ISSUES RELATED TO THE ACCELERATION OF THE DEVELOPMENT OF SYNTHETIC BIOLOGY 2
• Table of Contents 2
• I. INTRODUCTION 2
• I.1. Context 2
• I.2. Objectives of the report 2
• II. STATE OF THE ART: METHODS, APPLICATIONS, ECONOMIC IMPACT AND RISKS 2
• II.1. Cross-field synthetic biology methodology state-of-the-art 2
• II.2. Human health applications 2
• II.3. Global food production, nutrition and supply safety 2
• II.4. Environment and climate change 2
• II.5. Bioproduction of chemicals and biomaterials 2
• II.6. Market growth and economic impact 2
• II.7. Synthetic biology risks 2
• III. SYNTHETIC BIOLOGY AND ETHICAL PRINCIPLES 2
• III.1. Beneficence and non-maleficence 2
• III.2. Precautionary principle and risk mitigation 2
• III.3. Protecting future generations 2
• III.4. Justice and fairness 2
• III.5. Equity 2
• III.6. Solidarity 2
• III.7. Transparency and accountability 2
• IV. LEGAL ISSUES AND GOVERNANCE 2
• IV.1. Is the international human right framework being challenged by the recent developments in synthetic biology? 2
• IV.2. Are the existing regulations and governing bodies sufficiently robust to regulate the current synthetic biology issues? 2
• V. RECOMMENDATIONS 2
• SELECTED BIBLIOGRAPHY 2
• I. INTRODUCTION 3
• I.1. Context 3
• 1. Synthetic biology is a nascent interdisciplinary field of science that applies engineering principles to biology, with the goal of creating organisms or biological systems with novel functions that do not exist in nature. Armed with gene-based tech... 3
• 2. Synthetic biology applications range from improving healthcare – by better diagnoses and better treatments – to a wide range of applications in agriculture and the environment. Some of these applications are already in the market. In fact, the glob... 3
• 3. Concretely, synthetic biology has great potential in the medical and pharmaceutical domains. The mRNA vaccines invented and used during the COVID 19 crisis has made this potential revolution more visible than ever to the world. Furthermore, synthet... 3
• 4. However, synthetic biology involves risks to humans and the whole environment. Amongst these should be mentioned the unpredictability and uncertainty regarding the potential impacts of its applications. It is also a dual use discipline. 3
• 5. Attempting to define the concept of Synthetic biology is not a simple task. Synthetic biology is a dynamic field, rapidly developing and self-constructing, which has an impact on its definition. 3
• 6. In 2010, synthetic biology was defined by the US Presidential Committee for the study of Bioethical Issue as “... the name given to an emerging field of research that combines elements of biology, engineering, genetics, chemistry, and computer scie... 3
• 7. In 2013, it was defined by Polizzi as the “rapidly developing field that aims to engineer new biological systems that do not already exist in Nature or redesign existing systems from scratch” (Polizzi, 2013). 4
• 8. In 2014, in their report “Opinion on Synthetic Biology 1 Definition”, the European Union Scientific Committees suggested the following operational definition: “Synbio is the application of science, technology and engineering to facilitate and acce... 4
• 9. In 2019, the National Human Genome Research Institute (NHGRI) of the United States National Institutes of Health (NIH), defined Synthetic biology as “a field of science that involves redesigning organisms for useful purposes by engineering them to... 4
• 10. For the purpose of this report, the following definition from the Royal Society, agnostic of its purpose, will be adopted: “Synthetic biology involves the design and construction of novel artificial biological pathways, organisms and devices or th... 4
• I.2. Objectives of the report 4
• 11. The International Bioethics Committee (IBC) seeks to anchor this report in the fundamental principles stated in Universal Declaration on Bioethics and Human Rights (UDBHR). For instance, article 17 raises multiple aspects to be considered in the r... 4
• 12. Pertaining to synthetic biology, in assessing the potential benefit/risk of synthetic biology applications, requirements expressed in article 17 ought to be considered. In deciding the benefits and risks of synthetic biology applications for human... 4
• 13. Adding to these impacts of applications among forms of life, since human beings are an integral part of the biosphere in which they live, they have a commitment to protect the environment and the biosphere for their sustainable utility and for the... 4
• 14. Like all emerging technologies, synthetic biology raises ethical challenges such as the question of accessibility, in terms of justice and equity, transparency in research and research security, as well as the protection of future generations espe... 4
• 15. The rapid development of synthetic biology also constitutes a challenge to its regulators, from now and then, to distinguish what is truly new from what is not within the scope of existing applicable regulatory mechanisms. 5
• 16. Since the IBC’s mission is to promote reflection on the ethical and legal issues raised by research in the life sciences and their applications, the committee decided to reflect on these and other ethical and legal issues that stem from the devel... 5
• 17. Reflecting on these ethical and legal issues is just a step towards the committee’s reaching the ultimate goal of this report: concluding and issuing recommendations to key local, regional and global entities without whom, and without their role ... 5
• II. STATE OF THE ART: METHODS, APPLICATIONS, ECONOMIC IMPACT AND RISKS 5
• 18. Synthetic biology has expanded from a fundamental research approach to impact areas ranging from medical and pharmaceutical fields to environmental protection and remediation, food production, bioenergy production, fabrics and textile dyes product... 5
• 19. This section will be devoted to presenting the state of art of synthetic biology through giving general characteristics of synthetic biology, explaining the most developed methodologies, applications, impact and market directions of the discipline... 5
• II.1. Cross-field synthetic biology methodology state-of-the-art 5
• 20. This section addresses key current methodologies that drive the field, starting with DNA synthesis, assembly and editing at different scales (from single base edits to full synthetic genomes), followed by protein engineering, metabolic engineerin... 5
• II.2. Human health applications 5
• 21. This section presents contributions of synthetic biology to the medical and pharmaceutical fields contributing to human health, as drug discovery and synthesis, de novo therapeutic and diagnostic proteins and biosensors, gene therapy, and how the... 5
• II.3. Global food production, nutrition and supply safety 6
• 22. This section presents contributions of synthetic biology for improving crops and livestock through increased crop yields, nutritional value and reduced dependency on pesticides thus addressing the food security and shortage while preserving the e... 6
• II.4. Environment and climate change 6
• 23. This section presents contributions of synthetic biology to cleaner environment and climate change mitigation with implications on One Health of species across domains of life. 6
• 24. These approaches include monitoring and detoxification of pollutants, biomanufacturing processes aimed at reducing reliance on fossil fuels and efficient recycling of waste products, limiting carbon emissions through carbon capture technologies an... 6
• II.5. Bioproduction of chemicals and biomaterials 6
• 25. This section presents contributions of synthetic biology to production by engineered organisms of fine chemicals, as drugs (e.g. anti-malaria, antibiotics), food additives (e.g., beta-carotene), flavour, fragrance and textile dyes compounds (e.g... 6
• II.6. Market growth and economic impact 6
• 26. The impact of Synthetic Biology is no longer only academic. With entrepreneurial and private investment driven technological development, clear projections of increased market share across the above-mentioned domains are backed by demonstrated ... 6
• II.7. Synthetic biology risk 6
• 27. As mentioned in the introduction, in spite of the great potential synthetic biology has in various domains, synthetic biology has the potential to pose serious biological hazards. These potential threats have traditionally been categorized into bi... 6
• II.7.1. Biosafety and Biosecurity risks 6
• 28. According to the World Health Organisation, "Biosafety is a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment. It is based on recognition ... 6
• 29. Biosecurity can be described as ‘‘security against the inadvertent, inappropriate, or intentional malicious or malevolent use of potentially dangerous biological agents or biotechnology, including the development, production, stockpiling, or use o... 7
• 30. As a result of the accelerating development of synthetic biology field and its increasing complexity, its potential risks may remain unpredictable and uncertain. However, risks related to human health and the environment posed by synthetic biolo... 7
• 31. Other three important biosafety considerations include intentional or unintentional release of synthetic organisms into the environment, increase in the rate of horizontal gene transfer in the environment, and creation of antibiotic resistant supe... 7
• 32. Biosecurity risks of synthetic biology is mainly focused on the theft and misuse of fixed, current, and intangible assets in synthetic biology laboratories, including synthetic biology components (Minimal genome, Orthogonal biosystems/xenobiology,... 7
• 33. In recent years, cyberbiosecurity has become an issue as biological laboratory equipment can be controlled and operated through the internet, with the increasing reliance on digital information and the calculation of synthetic biology on servers a... 7
• 34. Synthetic biology security threats are of different type from those posed by chemicals, explosive, or radioactive material. 7
• II.7.2. Dual Use 7
• 35. According to the WHO, “Dual-use research of concern (DURC) describes research that is intended to provide a clear benefit, but which could easily be misapplied to do harm. It usually refers to work in the life sciences, but the principles are also... 7
• 36. Synthetic biology approaches can now be used to rapidly synthesize viruses, as well as functional gene segments from viruses that can confer increased virulence and infectivity in both humans and animals. Synthetic biology can also be used to acce... 7
• 37. “Gain of function” research on microorganisms have been carried out in the past two decades to better understand human-pathogen interactions and to develop preventive measures against these more virulent pathogens. However, this technology has bio... 7
• 38. This harm is not only confined to humans and animals but can affect agriculture (food production and food security) as well as environmental health and security. 7
• 39. As synthetic biology has the potential for dual use research, it is important to raise awareness amongst scientists and engineers in this field and to develop strict regulations to prevent the misuse of the technology (Wimmer, 2018). 8
• III. SYNTHETIC BIOLOGY AND ETHICAL PRINCIPLES 8
• 40. Without doubt, synthetic biology holds enormous promise in terms of beneficial impact for human health, animal well-being, ecological balance, and stabilising global climate. The ethical principle of beneficence is thus to be seen as one major asp... 8
• 41. However, the hope to realize its benefits on a global scale requires careful assessment in light of other ethical principles that should guide synthetic biology's current and future development. Synthetic biology's future also raises questions of ... 8
• III.1. Beneficence and non-maleficence 8
• 42. Beneficence is an ethical principle often explained in terms of utility or the best consequences. It requires actors to be primarily motivated by altruism as opposed to self-interest or selfishness. 8
• 43. Non-maleficence is the principle requiring agents to refrain from causing foreseeable and avoidable harms. Beneficent and non-maleficent actions or products are ethically praiseworthy and moral obligations. Pertaining to synthetic biology, product... 8
• 44. Beneficence and non-maleficence will be addressed in this section, inter alia, through the perspective of sustainable development. Applications of synthetic biology could have positive or negative implications for sustainable development including... 8
• III.2. Precautionary principle and risk mitigation 9
• 45. The increasing complexity in the range of tools and the fields of applications of synthetic biology as well as the potential for cumulative, synergistic and scaling effects may all result in unpredictability and uncertainty regarding the potential... 9
• III.3. Protecting future generations 9
• 46. The principles of environmental sustainability and intergenerational equity should be considered when assessing the use of synthetic biology applications that may have long-term or permanent effects on the environment and the functions that nature... 9
• III.4. Justice and fairness 9
• 47. Synthetic biology holds enormous promises in terms of beneficial impact for human health, animal well-being, and environmental protection. However, with any technological advance come burdens and risks. The principle of justice and fairness relate... 9
• 48. Justice and fairness are concepts with closely related but distinct meanings. Justice is the broader concept, whereas fairness provides the specification of justice where distribution of burdens and benefits is equitable. 9
• 49. Pertaining to synthetic biology, fairness reflects the process where products reach those individuals and communities who would most benefit from them. It also reflects mechanisms that ensure that the potential risks of synthetic biology to humans... 9
• III.5. Equity 9
• 50. The principle of equity consolidates the concept of fairness since equity is defined as the quality of being fair and impartial. Wealthy nations are at the forefront of synthetic biology. The development of the applications of synthetic biology is... 9
• III.6. Solidarity 10
• 51. Synthetic biologists must engage and collaborate directly as part of a truly global ecosystem to address needs in many different communities, including in developing countries. Otherwise, synthetic biology technologies risk a lack of support in co... 10
• 52. As a promising field, international solidarity and cooperation in synthetic biology can accelerate innovations and extends the effectiveness of synthetic biology in attaining the sustainable development goals (SDGs) such as improving global health... 10
• 53. To bridge the gap between the Global North and Global South, a comprehensive approach is needed. This approach should focus on solidarity, fair resource distribution, and capacity building. Collaborative efforts can pool resources, knowledge, and ... 10
• 54. International efforts are needed to implement joint training programs and workshops in developing countries to build local expertise in synthetic biology. Scholarships and fellowships for students and researchers from the Global South, where both ... 10
• 55. Another essential need is to develop harmonised regulatory frameworks that facilitate the approval and deployment of synthetic biology applications across borders. Policymakers and local communities (including indigenous groups) from the Global So... 10
• 56. The iGEM competition (https://igem.org) and the Synthetic Yeast Genome Project (Sc 2.0) (https://syntheticyeast.github.io) are notable examples of successful global collaborations in synthetic biology. International research collaborations have al... 10
• III.7. Transparency and accountability 11
• 57. Considering the growing public mistrust against scientists, research and development in synthetic biology is likely to raise myths, misconception, mis/disinformation, conspiracy theories, worries about the real potential for abuse, all of these yi... 11
• IV. LEGAL ISSUES AND GOVERNANCE 11
• IV.1 Is the international human right framework being challenged by the recent developments in synthetic biology? 11
• 58. Synthetic biology opens new perspectives about living organisms, cells, and perhaps, even life forms. Some synthetic biology developments raise questions in relation to fundamental human rights or as to the proper characterization of synthetic bio... 11
• 59. As recent and anticipated developments in synthetic biology lead us to revisit the relationship of human with ‘nature’, and perhaps even challenge our very understanding of what life is, we ought to revisit how this impacts our human rights, and t... 11
• IV.2 Are the existing regulations and governing bodies sufficiently robust to regulate the current synthetic biology developments? 11
• 60. Given the above-described scientific developments (including potential benefits and risks) and the ethical issues that ensues, the existence of a robust legal framework locally with a global stewardship, as well as adequate governing bodies are es... 11
• 61. This section will give a high-level overview of the current global legal framework (Sundaram, 2023). Furthermore, it will identify critical elements that should be addressed in regulatory frameworks to be robust enough to protect the fundamental ... 11
• V. RECOMMENDATIONS 12
• 62. This report intends to offer ethical guidance to the responsible development of synthetic biology. Towards that end, we will provide recommendations to the following stakeholders: governments, the academic and research community, the industry, the... 12
• 63. While the International Bioethics Committee is still considering what will be the key recommendations, it is anticipating the following could be part of the final report: 12
•  The development of an international Code of conduct on the responsible developments of synthetic biology; 12
•  The creation of tools or appropriate international fora to assure transparency as to the overall state of development of the synthetic biology field and allow researchers of the world to access knowledge in the spirit of open science; 12
•  The support of an agile and well-informed international forum to keep up with the developments and alert to risks/ unethical uses; 12
•  Raise awareness on the need for capacity building in all parts of the world; 12
•  Ensure a more equal access to the know-how, data (catalogues) and tools (including the “biobricks”), and the products that will result from it; 12
•  Offer suggestions for training/teaching/sharing synthetic biology with the public. 12
•  Offer more ethics training to all disciplines involved in the development of synthetic biology 12
•  Provide training and resources to regulatory bodies in developing countries to help them establish and enforce effective regulations 12
• SELECTED BIBLIOGRAPHY 13