BNS0029

Written evidence submitted by Dr Tatyana Novossiolova and Professor Malcolm Dando

Summary

This written evidence focuses on the importance of strengthening the international norm of biological prohibition enshrined in the 1975 Biological and Toxin Convention (BTWC) as an essential requirement for the development and implementation of an effective and integrated approach to the countering of biological risks regardless of their origins. In particular, the evidence elucidates the need for promoting a shared understanding among all those in the life sciences, whether in government, industry, or academia of the risk of deliberate disease and the role that they can play in preventing this risk.[1]

1. Disease outbreaks – whether naturally occurring, or resulting from the unintentional or deliberate release of pathogens and/or toxins – can have significant consequences in terms of human, economic, environmental, and material costs and put a serious strain on the state’s capacity to adequately respond to threats to public, animal, or plant health. Given the complex spectrum of biological threats with no single focal point and the difficulty in immediately establishing the origins of a disease outbreak, there is a need for a multifaceted and multi-layered, internationally coordinated set of measures which allow states to respond to biological events effectively and efficiently.[2] It is helpful to think of this required approach as an integrated and comprehensive web of prevention in which the efforts aimed at preventing the accidental release of biological agents or toxins, including naturally occurring disease and the efforts aimed to prevent the deliberate release of biological agents and toxins are complementary and reinforce each other, to create an effective counter to the threat of disease, regardless of its origins.[3]

2.  The value of the web of prevention has been acknowledged as part of the proceedings of the Biological and Toxin Weapons Convention (BTWC), the principal international agreement that codifies the norm of prohibition of the development, stockpiling, acquisition, and retention of biological and toxin weapons. The Fifth Review Conference of the BTWC held in 2002 agreed an Inter-Sessional Programme of Work to discuss and promote common understanding and effective action on the following topics:

i. the adoption of necessary national measures to implement the prohibitions set forth in the Convention, including the enactment of penal legislation;

ii. national mechanisms to establish and maintain the security and oversight of pathogenic microorganisms and toxins;

iii. enhancing international capabilities for responding to, investigating and mitigating the effects of cases of alleged use of biological or toxin weapons or suspicious outbreaks of disease;

iv. strengthening and broadening national and international institutional efforts and existing mechanisms for the surveillance, detection, diagnosis and combating of infectious diseases affecting humans, animals, and plants;

v. the content, promulgation, and adoption of codes of conduct for scientists.[4]

3. These issues continue to be at the forefront of BTWC States Parties’ considerations during the current Intersessional Programme, 2018-2020 at the biannual Meetings of Experts and Meetings of States Parties. They are being considered in relation to strengthening cooperation and assistance within the framework of the Convention; review of developments in the field of science and technology related to the Convention; strengthening national implementation of the Convention; assistance, response, and preparedness in case of suspected use of biological weapons; and institutional strengthening of the Convention.[5]

4. The need for promoting awareness of the norm against biological weapons among those in the life sciences has been recognised by BTWC States Parties as a way of ensuring the effective and comprehensive implementation of all elements of the Convention. The Eighth Review Conference of the BTWC in 2016, when considering Article IV on the national implementation of the Convention noted the value of national implementation measures to:

“(a) implement voluntary management standards on biosafety and biosecurity;

(b) encourage the consideration of development of appropriate arrangements to promote awareness among relevant professionals in the private and public sectors and throughout relevant scientific and administrative activities;

(c) promote amongst those working in the biological sciences awareness of the obligations of States Parties under the Convention, as well as relevant national legislation and guidelines;

(d) promote the development of training and education programmes for those granted access to biological agents and toxins relevant to the Convention and for those with the knowledge or capacity to modify such agents and toxins;

(e) encourage the promotion of a culture of responsibility amongst relevant national professionals and the voluntary development, adoption and promulgation of codes of conduct;

(f) strengthen methods and capacities for surveillance and detection of outbreaks of disease at the national, regional and international levels, noting that the International Health Regulations (2005) are important for building capacity to prevent, protect against, control and respond to the international spread of disease; and

(g) prevent anyone from developing, producing, stockpiling, or otherwise acquiring or retaining, transporting or transferring and using under any circumstances, biological agents and toxins, equipment, or their means of delivery for non-peaceful purposes”.[6]

When considering Article VII of the Convention on international assistance in case of an alleged use of biological weapons, the Eighth Review Conference recognised:

“capacity building at the national and international levels as the most immediate imperative for enhancing and strengthening the capacity of the States Parties to promptly and effectively detect and respond to the alleged use or threat of use of biological weapons.”[7]

When considering Article X of the Convention on international cooperation and assistance, the Eighth Review Conference agreed on value of:

“working together to promote capacity building in the fields of vaccine and drug production, disease surveillance, detection, diagnosis, and containment of infectious diseases as well as biological risk management. The Conference affirms that building such capacity would directly support the achievement of the objectives of the Convention.”[8]

5. Similarly, the World Health Organisation has recommended that “considerations for [countering] deliberate releases of biological or chemical agents should be incorporated into existing public health infrastructures, rather than developing separate infrastructures”.[9] The World Health Organisation has further underscored that researchers and institutions need to develop “a better understanding of the potential risks associated with accidents and the deliberate misuse of life sciences research” and “learn about practical measures that will enable them to manage some of the risks posed by life sciences research.”[10]

6. In January 2019, the World Organisation for Animal Health (OIE) published Guidelines for Responsible Conduct in Veterinary Research: Identifying, Assessing, and Managing Dual Use which seek to raise awareness about the dual-use potential of research in veterinary settings – the fact that benignly intended and legitimate life science research could be misused to cause harm to humans, animals, or the environment.[11] This guidance document is intended to support veterinary professionals, researchers and other stakeholders to effectively identify, assess and manage dual-use implications. It notes that:

“researchers and institutions should integrate dual-use risk assessment into their existing standard risk assessment procedures. They should exercise their professional responsibility, performing a continued, detailed and well-informed risk analysis for all stages of the proposed research, from project initiation to data publication.” [12]

The document further stresses that “the responsibility for the identification, assessment and management of dual-use implications rests to differing degrees across many stakeholders throughout the research life cycle” including researchers and their host institutions, grant and contract funders, companies, educators, scientific publishers and other communicators of research, and regulatory authorities.

7. It is thus evident that developing national capacities for countering deliberate disease constitutes an essential requirement for the effective management of biological risks in the 21st century. The life science community has a crucial role to play in strengthening the norm of biological prohibition and in promoting a shared recognition of the need to internalise corresponding modes of behaviour and reasoning in the everyday practice of life scientists. There are at least five areas of action to which those engaged in the life sciences can actively contribute, in order to promote a shared understanding of the risk of deliberate disease and thus enhance biological security. These include:

It is essential that biological security measures and considerations are built-in at every stage of the life science research process to ensure a comprehensive risk assessment and management. Biological security (including the norm of biological prohibition) needs to be perceived as an indivisible element of life science practice that exemplifies the professional responsibility of those in the life sciences to ensure that their work is used only to the benefit of humanity and the environment.[13] 

Dr Tatyana Novossiolova, Research Fellow, Law Program, Centre for the Study of Democracy, Sofia, Bulgaria.

Professor Malcolm Dando, Leverhulme Emeritus Fellow, Section of Peace Studies and International Development, University of Bradford, UK.

The views expressed here are those of the authors alone. They may not represent the views of their affiliated organisations and should not be taken as an official statement or position of the affiliated organisations.

29 October 2020

 

 

 


[1] Tatyana Novossiolova, Jim Whitman, and Malcolm Dando, ‘Altering an Appreciative System: Lessons from Incorporating Dual-Use Concerns into the Responsible Science Education of Biotechnologists’, Futures, vol. 108 (2019), pp. 25-60, available at https://doi.org/10.1016/j.futures.2019.02.001 (accessed 8 July 2020).

[2] Tatyana Novossiolova, ‘Comparing responses to natural, accidental and deliberate biological events’, OIE Scientific and Technical Review, vol.36:2 (2017), special issue, Tammay Beckham (eds.) Biological Threat Reduction, pp. 647-654, available at https://pubmed.ncbi.nlm.nih.gov/30152455/.

[3] Tatyana Novossiolova, Simon Whitby, Malcolm Dando, and Graham S. Pearson, Strengthening the Biological and Toxin Weapons Convention: The Vital Importance of a Web of Prevention for Effective Biosafety and Biosecurity in the 21st Century, Briefing Paper for the BTWC Meeting of States Parties, November 2019, available at https://bradscholars.brad.ac.uk/handle/10454/17580.

[4] Fifth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document, BWC/CONF.V/17, 19 November – 7 December 2001 and 11-22 November 2002, Geneva, Switzerland, https://www.unog.ch/bwcdocuments/2001-11-5RC/BWC_CONF.V_17.pdf.

[5] Meeting of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Report of the Meeting of States Parties, BWC/MSP/2017/6, 4-8 December 2017, Geneva, Switzerland, https://undocs.org/en/bwc/msp/2017/6.

[6] Eighth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document, BWC/CONF.VIII/4, 7-25 November 2016, Geneva, Switzerland, https://www.unog.ch/80256EDD006B8954/(httpAssets)/19831FF45AE88E89C12580D80038951C/$file/BWCCONF.VIII4+English+.pdf.

[7] Eighth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document, BWC/CONF.VIII/4, 7-25 November 2016, Geneva, Switzerland, https://www.unog.ch/80256EDD006B8954/(httpAssets)/19831FF45AE88E89C12580D80038951C/$file/BWCCONF.VIII4+English+.pdf.

[8] Eighth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document, BWC/CONF.VIII/4, 7-25 November 2016, Geneva, Switzerland, https://www.unog.ch/80256EDD006B8954/(httpAssets)/19831FF45AE88E89C12580D80038951C/$file/BWCCONF.VIII4+English+.pdf.

[9] World Health Organization, Public health response to biological and chemical weapons (Geneva: World Health Organization, 2004), https://www.who.int/csr/delibepidemics/biochemguide/en/ (accessed 24 October 2019).

[10] World Health Organization, Responsible life sciences research for global health security: a guidance document (Geneva: World Health Organization, 2010),

http://www.who.int/csr/resources/publications/HSE_GAR_BDP_2010_2/en/ (accessed 25 October 2019).

[11] World Organisation for Animal Health (OIE), Guidelines for responsible conduct in veterinary research (Paris: World Organisation for Animal Health, 2019),

https://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/BTR/A_GUIDELINES_VETERINARY_RESEARCH.pdf (accessed 25 October 2019).

[12] World Organisation for Animal Health (OIE), Guidelines for responsible conduct in veterinary research (Paris: World Organisation for Animal Health, 2019),

https://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/BTR/A_GUIDELINES_VETERINARY_RESEARCH.pdf (accessed 25 October 2019).

[13] Tatyana Novossiolova, Simon Whitby and Malcolm Dando, ‘Enhancing the Governance of Dual-Use Life Science Research: Making Aspirational Codes of Conduct for Life Scientists Effective’ in Tomas Zima and David Weisstub, Medical Research Ethics: Challenges in the 21st Century, (forthcoming in 2021).