¹ For discussion see, for example, Jasanoff, S, The Ethics of Invention: Technology and the Human Future (Norton & Co, 2016)Google Scholar.

² WHO, The World Health Report 2007: A Safer Future: Global Public Health Security in the 21st Century (WHO, 2007), 1. Emphasis added.

³ Avian influenza or A/H5N1.

⁴ Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome. For discussion, see Elbe, S, “Should HIV/AIDS be Securitised? The Ethical Dilemmas of Linking HIV/AIDS and Security” (2006) 50(1) International Studies Quarterly 119 CrossRefGoogle Scholar.

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⁶ Black defines regulation as “the intentional use of authority to affect behaviour of a different party according to set standards, involving instruments of information-gathering and behaviour modification” ( Black, J, “Critical Reflections on Regulation” (2002) 27 Australian Journal of Legal Philosophy 1)Google Scholar.

⁷ International Health Regulations (WHA58/2005/REC/1, 23 May 2005).

⁸ WHO, Report of the Ebola Interim Assessment Panel (WHO 2015), 13. Emphasis added.

⁹ This requires all Member States to behave with appropriate responsibility towards the international community in the adoption of travel and trade restrictions. Moreover, this provision also requires that Member States are to inform the WHO of additional measures and to provide a scientific rationale and justification that can be shared among Member States (Art 43(3)). The WHO may request a Member State to reconsider the application of additional measures (Art 43(4)).

¹⁰ WHO, supra, note 8, 12. Emphasis added.

¹¹ Ibid, 20. Emphasis added.

¹² Council of Europe, The Handling of the H1N1 Pandemic: More Transparency Needed (CoE, 2010), Draft Resolution A1. See further Council of Europe, Resolution 1749, 24 June 2010; Council of Europe, Recommendation 1929, 24 June 2010. Also see Cohen, D and Carter, P, “WHO and the Pandemic Flu ‘Conspiracies’” (2010) 340 British Medical Journal c2912 CrossRefGoogle ScholarPubMed.

¹³ Council of the EU, Council Conclusions on Lessons Learned from the A/H1N1 Pandemic – Health Security in the European Union, Brussels, 13 September 2010.

¹⁴ European Parliament Resolution of 8 March 2011 on Evaluation of the Management of H1N1 Influenza in 2009-2010 in the EU (2010/2153(INI)) OJ C 199E/7.

¹⁵ Resilience has been described as the “capacity of a system to absorb disturbance and reorganise while undergoing change so as to still retain essentially the same function, structure and feedbacks, and therefore identity” – see Folke, CSR and others, “Resilience Thinking: Integrating Resilience, Adaptability and Transformability” (2010) 15(4) Ecology and Society 20, available at <www.ecologyandsociety.org/vol15/iss4/art20/>. Emphasis addedCrossRefGoogle Scholar.

¹⁶ WHO, supra, note 8, 5. Emphasis added.

¹⁷ Prominent recent examples of this being: Davies, SE and others, Disease Diplomacy: International Norms and Global Health Security (John Hopkins University Press, 2015)CrossRefGoogle Scholar; Bennett, B and Davies, SE (eds), “Special Issue: Global Health Governance of Public Health Emergencies” (2017) 25(2) Medical Law Review 181 CrossRefGoogle Scholar. On the lack of engagement with citizen participation in public health more generally, see Flear, ML, Governing Public Health (Hart, 2015)Google Scholar, Ch 1 “Context, Approach and Overview”, 15–20.

¹⁸ See, for example, Cloatre, E, Pills for the Poorest (Palgrave Macmillan, 2013)CrossRefGoogle Scholar.

¹⁹ Rationality is described as “a way of doing things that … [is] oriented to specific objectives and that … [reflects] on itself in characteristic ways”: Rose, N and others, “Governmentality” (2006) 2 Annual Review of Law Society and Science 83, 84 CrossRefGoogle Scholar.

²⁰ Where there is reference to the EU, the focus is on the EU’s regulatory order, which is one level of the multi-level system of governance. Within that system the EU level interacts with a range of other regulatory orders including those at the national level. See further Hooghe, L and Marks, G, Multilevel Governance and European Integration (Rowman & Littlefield, 2001)Google Scholar.

²¹ Flear, supra, note 17; Frischhut, M and Greer, S, “EU Public Health Law and Policy – Communicable Diseases” in TK Hervey and others (eds), Research Handbook on EU Health Law and Policy (Edward Elgar, 2017)Google Scholar; Hervey, TK and McHale, JV, European Union Health Law (Cambridge University Press, 2015)CrossRefGoogle Scholar, especially Ch 15 “Risk: tobacco, food, alcohol”.

²² See Bennett and Davies, supra, note 17.

²³ For discussion, see Flear, supra, note 17.

²⁴ As discussed in modernisation theory: Beck, U, Risk Society: Towards a New Modernity (Sage, 1986)Google Scholar; Giddens, A, The Constitution of Society (Polity, 1984)Google Scholar; Giddens, A, Modernity and Self-Identity (Polity, 1991)Google Scholar; Luhmann, N, Observations on Modernity (Stanford University Press, 1998)CrossRefGoogle Scholar. Foucault did not have a theory of reflexivity, but for such an addition to his thinking see Butler, J, The Psychic Life of Power (Stanford University Press, 1997)CrossRefGoogle Scholar.

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²⁸ ibid 47.

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³⁰ For discussion of “technology” see Flear, supra, note 17, Ch 1 “Context, Approach and Overview”, 6, 20–22.

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³⁵ WHO Alma-Ata Declaration on Primary Health Care 1978; WHO Ottawa Charter for Health Promotion 1986; Adelaide Recommendations on Healthy Public Policy 1988; Rio Political Declaration on Social Determinants of Health 2011.

³⁶ Or more accurately “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” found in Art 12 International Covenant on Economic, Social and Cultural Rights (16 December 1966, entered into force 3 January 1976) 993 UNTS 3. In the European regional human rights system, Arts 11 and 13 European Social Charter (Revised) (3 May 1996, entered into force 1 July 1999, 2151 UNTS 277, ETS 163) are important in that they relate to the treatment of illness. Specifically, Art 13 provides that “anyone without adequate resources has the right to social and medical assistance”. Art 11 provides that “everyone has the right to benefit from any measures enabling him to enjoy the highest standard of health attainable” including through measures which “remove as far as possible the causes of ill-health” and “prevent as far as possible epidemic, endemic and other diseases, as well as accidents”. As for the European Convention on Human Rights and Fundamental Freedoms (4 November 1950, entered into force 3 September 1953) ETS 5, signature states are required to take reasonable steps to protect life under Art 2 on the right to life (Osman v UK [1999] 1 FLR 193).

³⁷ The right to adequate food, clothing and housing, the right to freedom from hunger, and the right to environmental and industrial hygiene are found in Arts 11 and 12 ICESCR. Other rights, including the right to liberty and security of the person, freedom from coerced labour, liberty of movement, freedom of thought, conscience and religion and freedom from discrimination, are found in Arts 4, 8, 9, 12, 18 and 26 International Covenant on Civil and Political Rights (16 December 1966, entered into force 23 March 1976) 999 UNTS 171 (ICCPR). In the European regional human rights system, the Art 2 European Convention on Human Rights and Fundamental Freedoms (4 November 1950, entered into force 3 September 1953) ETS 5 on the right to life provides that signature states are required to take reasonable steps to protect life (Osman v UK [1999] 1 FLR 193). For discussion see Tobin, J, The Right to Health in International Law (Oxford University Press, 2012)Google Scholar; Toebes, B and others (eds), Health and Human Rights in Europe (Intersentia, 2012)Google Scholar.

³⁸ In particular through, Committee on Economic, Social and Cultural Rights, “General Comment No 14: The right to the highest attainable standard of health (art 12)” (11 August 2000) UN Doc E/C.12/2000/4, which spells out the content.

³⁹ Art 168(3) TFEU.

⁴⁰ According to the Explanatory Notes for the CFR in respect of Art 35 – see Explanations Relating to the Charter of Fundamental Rights (2007/C 303/02) OJ C 303/17.

⁴¹ See also discussion of “known unknowns” (those risks that we know we don’t know about) and “unknown unknowns” (those risks that we don’t know that we don’t know about) in Zedner, supra, note 31.

⁴² More generally, see Ericson, RV and Doyle, A, Uncertain Business: Risk, Insurance and the Limits of Knowledge (University of Toronto Press, 2004)Google Scholar; Lakoff, A, “From Population to Vital System” in A Lakoff and SJ Collier (eds), Biosecurity Interventions: Global Health and Security in Question (Columbia University Press, 2008)CrossRefGoogle Scholar; O’Malley, P, Risk, Uncertainty and Government (Glasshouse Press, 2004)Google Scholar.

⁴³ Douglas, M and Wildavsky, A, Risk and Culture: An Essay on the Selection of Technical and Environmental Dangers (University of California Press, 1982)Google Scholar; Luhmann, N, Risk: A Sociological Theory (de Gruyter, 1993)Google Scholar.

⁴⁴ In general see Fidler, DP and Gostin, LO, Biosecurity in the Global Age: Biological Weapons, Public Health, and the Rule of Law (Stanford University Press, 2007)Google Scholar; Hinchcliffe, S and Bingham, N, “Securing Life: the emerging practices of biosecurity” (2008) 40(7) Environment and Planning A 1534 CrossRefGoogle Scholar; Lentzos, F, “Rationality, Risk and Response: A Research Agenda for Biosecurity” (2006) 4(1) BioSocieties 453 CrossRefGoogle Scholar.

⁴⁵ A focus noted as transferred from the United States’ Centre for Disease Control to the WHO and globally by one of its experts, see Ashraf, H, “David Heymann – WHO’s Public Health Guru” (2004) 4(12) The Lancet Infectious Diseases 785 CrossRefGoogle Scholar. For the roots of this approach, see Henderson, DH, “Surveillance Systems and Intergovernmental Cooperation” in S Morse, Emerging Viruses (Oxford University Press, 1993)Google Scholar.

⁴⁶ S Collier and A Lakoff, “Vital Systems Security” (2007) ARC Working Paper No 2, 3. Emphasis added. Also see Lakoff, A, “Real-time Biopolitics: The actuary and the sentinel in global public health” (2015) 44(1) Economy and Society 40 CrossRefGoogle Scholar; Roberts, SL and Elbe, S, “Catching the Flu: Syndromic Surveillance, Algorithmic Governmentality and Global Health Security” (2017) 48(1) Security Dialogue 46 CrossRefGoogle Scholar.

⁴⁷ Dean, supra, note 29, 226. Emphasis added.

⁴⁸ This approach stems in large part from Ferguson, NM and others, “Strategies for Containing an Emerging Influenza Pandemic in Southeast Asia” (2005) 437 Nature 209 CrossRefGoogle ScholarPubMed. Also see Longini, IM and others, “Containing Pandemic Influenza at the Source” (2005) 309 Science 1083–1087 CrossRefGoogle ScholarPubMed.

⁴⁹ Weinberg, J, “Responding to the Global Challenge of Infectious Disease” in M McKee and others (eds), International Co-operation in Health (Oxford University Press, 2001)Google Scholar.

⁵⁰ See “Global Health Security Initiative”, available at <www.ghsi.ca/english/index.asp>.

⁵¹ Fidler, DP and Gostin, LO, “The New International Health Regulations: An Historic Development for International Law and Public Health” (2006) 34(1) Journal of Law, Medicine and Ethics 85, 86 CrossRefGoogle ScholarPubMed.

⁵² Art 2 IHR 2005. Emphasis added.

⁵³ On securitisation see Balzacq, T, “Preface” in Securitisation Theory: How Security Problems Emerge and Dissolve (Routledge, 2011)Google Scholar; de Larrinaga, M and Doucet, MG, Security and Global Governmentality (Routledge, 2010)CrossRefGoogle Scholar.

⁵⁴ Arts 5 and 13 and Annex 1 IHR, and Art 6 and Annex 2 IHR.

⁵⁵ For example: WHO, Pandemic Influenza Risk Management (WHO 2017)Google Scholar.

⁵⁶ Art 57(1) IHR 2005 states the IHR and EU Treaties “should be interpreted so as to be compatible”. Art 3(4) states that States Parties have “the sovereign right to legislate and to implement legislation in pursuance of their health policies”, and in so doing they should uphold the IHR.

⁵⁷ Recital 6 Decision 1082/2013/EU on serious cross-border threats to health and repealing Decision 2119/98/EC OJ L 293/1.

⁵⁸ These are defined by Art 3(g) Decision 1082/2013/EU, ibid, as “a life- threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection”.

⁵⁹ Art 168(5) TFEU.

⁶⁰ Art 6(a) TFEU – and it must be of “added value” in order to comply with the principles of subsidiarity and proportionality under respectively Art 5(3)–(4) TEU.

⁶¹ Art 168(7) TFEU provides that EU action shall “respect the responsibilities of the Member States for the definition of their health policy…”.

⁶² Recital 1 Decision 1082/2013/EU, supra, note 57.

⁶³ European Commission, Programme of Cooperation on Preparedness and Response to Biological and Chemical Attacks [Health Security], G/FS D(2001) GG; European Commission, Strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – An EU CBRN Action Plan, COM(2009) 273 final; European Commission, Staff Working Document Bridging Security and Health: Towards the Identification of Good Practices in the Response to CBRN Incidents and the Security of CBR Substances, SEC(2009) 874.

⁶⁴ Established by Regulation (EC) 851/2004 establishing a European Centre for Disease Prevention and Control OJ L 142/1.

⁶⁵ Decision 2119/98/EC on a network for the epidemiological surveillance and control of communicable diseases OJ L 268/1.

⁶⁶ Art 8(1) Decision 1082/2013/EU, supra, note 57. Emphasis added.

⁶⁷ Based on Art 168(2) TFEU and Art 168(7) TFEU. See the documents referred to in supra, note 63 and European Commission, “Interim Document”: Technical Guidance on Generic Preparedness Planning for Public Health Emergencies, 2005. The guidance includes checklists “as a guide that may be used to assist in the development, revision or assessment of comprehensiveness of preparedness plans” (ibid, 3) and facilitates the “inter-operability of national plans, mainly by the creation of co-ordination mechanisms and analysis and communication tools that enhance co-operation between key Member States and Commission players” (ibid, 2, emphasis added).

⁶⁸ European Commission, Pandemic Influenza Preparedness and Response Planning in the European Community, COM(2005) 607 final, 8 (emphasis added). Also see European Commission, Communication on Strengthening Coordination on Generic Preparedness Planning for Public Health Emergencies at EU Level, COM(2005) 605 final.

⁶⁹ “EU Response to the Ebola Outbreak”, available at <ec.europa.eu/europeaid/regions/africa/west-africa/ebola-response_en>, accessed 19 October 2017.

⁷⁰ European Commission, The EU’s Response to Help Fight the Ebola Outbreak in West Africa, MEMO/14/520, 5 September 2014.

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⁸⁰ European Commission, supra, note 78, 3.

⁸¹ ibid 3.

⁸² European Commission, supra, note 78, 8–9. Emphasis added. See further European Commission, Combating HIV/AIDS within the European Union and in the Neighbouring Countries, 2006–2009, COM(2005) 654; European Commission, EU Strategy for Action on the Crisis in Human Resources for Health in Developing Countries, COM(2005) 642.

⁸³ Art 26(2) TFEU defines the internal market as “an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured…”.

⁸⁴ “Health strategy”, available at <ec.europa.eu/health/strategy/policy/index_en.htm>.

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⁸⁸ WHO, supra, note 8, 20.

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¹²⁹ ibid 218. This responsibility is grounded in virtue theory. For discussion see Fricker, supra, note 97, and Medina, supra, note 128.

¹³⁰ Medina, supra, note 128, 215.

¹³¹ Notably, participation rights have received growing attention. Most relevant to this article is the discussion within EU legal studies and global administrative law, see especially Mendes, J, Participation in EU Rule-making: A Rights-based Approach (Oxford University Press, 2011)CrossRefGoogle Scholar; Harlow, C, “Global Administrative Law: The Quest for Principles and Values” (2006) 17(1) European Journal of International Law 187 CrossRefGoogle Scholar.

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¹³⁸ ibid 20–21. Emphasis added.

¹³⁹ Cf Leach, M and Scoones, I, “The Social and Political Lives of Zoonotic Disease Models: Narratives, Science and Policy” (2013) 88 Social Science & Medicine 10 CrossRefGoogle ScholarPubMed.

¹⁴⁰ More broadly, the use of risk assessment in respect of highly unpredictable situations, including convicted criminals within the community, provides a way of reassuring the public – and, therefore, public legitimation of institutions – rather than actually protecting society. See Kemshall, H, Understanding Risk in Criminal Justice (McGraw-Hill, 2003)Google Scholar.

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¹⁴³ Power, supra, note 137, 21. Emphasis added.

¹⁴⁴ Medina, J, The Epistemology of Resistance: Gender and Racial Oppression, Epistemic Injustice, and Resistant Imaginations (Oxford University Press, 2012)Google Scholar.

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¹⁴⁷ These include adaptive management and its variants, which seeks to place environmental problems within the wider systems that produce them: Rist, L and others, “Adaptive Management: Where Are We Now?” (2012) 40(1) Environmental Conservation 5 CrossRefGoogle Scholar. On the variants of adaptive management, see Holling, CS (ed), Adaptive Environmental Assessment and Management (John Wiley and Sons, 1978)Google Scholar.

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¹⁴⁹ And for examples within the context of EU level GPHS, see European Commission, Staff Working Document on Strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – An EU CRBN Action Plan. Impact Assessment, SEC(2009) 790; European Commission, Staff Working Document on Strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – An EU CRBN Action Plan. Summary of Impact Assessment, SEC(2009) 791.

¹⁵⁰ For discussion, see Flear, supra, note 17, Ch 2 “EU Public Health Governance”, 56–63.

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¹⁷⁷ Brownsword, R and Yeung, K (eds), Regulating Technologies: Legal Futures, Regulatory Frames and Technological Fixes (Hart, 2008)Google Scholar; Elbe, S, Security and Global Health: Toward the Medicalisation of Insecurity (Polity Press, 2010)Google Scholar; Jasanoff, supra, note 1.