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Vaccines for Pandemic and Epidemic Diseases: Towards Defining the Space of EU Public Health between Security Policy and a Transnational Market

Published online by Cambridge University Press:  06 December 2017

Marco RIZZI
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Abstract

The EU is continuously developing strategies, policies and regulations to confront pandemic and epidemic diseases. The actions of the EU in this field do not happen in a vacuum but are instead embedded in a complex international and transnational network. This article suggests the existence of a tension between public health policy and a twofold set of competing considerations: growing security concerns and market pressures. To structure the argument the article examines three distinct but related aspects: first, it clarifies the different levels of decision-making impacting on the EU’s policy and regulation of vaccines for PEDs: these levels are described as international, transnational and domestic, and the key players involved at each level are also identified; second, it analyses levels of responsiveness to and preparedness for outbreaks and analyses how past experiences have oriented the policy debate; third, it discusses issues of accountability of vaccine developers, authorising authorities and rule-makers involved in preparedness and response to emerging PEDs.

Type
Articles
Information
European Journal of Risk Regulation , Volume 8 , Special Issue 4: Special Issue on the EU Public-Health-Security Nexus , December 2017 , pp. 686 - 699
Copyright
© Cambridge University Press 

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Footnotes

*

Dr Marco Rizzi, Senior Lecturer, Department of Law, University of Seychelles. This paper was first presented at the workshop “Germs, Bioterrorism and Chemical Attacks: Internal and External Security Perspectives”, Maastricht University Campus, Brussels, 21–22 November 2016. I wish to thank Anniek DeRuijter, Hylke Dijkstra, Catriona McLeish, Mark Flear, James Revill and Vigjilenca Abazi for their comments on an earlier draft, and Jessica Kerr for comments on later drafts.

References

1 The literature is vast, see for example: Hays, JN, Epidemics and Pandemics – Their Impact on Human History (ABC-CLIO, 2005)Google Scholar; Barry, JM, The Great Influenza: The Epic Story of the Deadliest Plague in History (Penguin, 2004)Google Scholar; Diamond, J, Guns, Germs and Steel: the Fates of Human Societies (Norton, 1997)Google Scholar; H Zinsser, Rats, Lice and History (first published 1935, Transaction Publishers, 2007).

2 Dijkstra, H and de Ruiter, A, “The Health-Security Nexus and the European Union: Toward a Research Agenda” (2017) 8 EJRR Google Scholar (Introduction to this Special Issue).

3 Data for the year 2015 show that travel to and from extra-EU countries represents as much as 37% of the total EU civilian air traffic, 12.9% to and from Africa, 7.1% Central and South America, 12.2% Middle East, 2% the Indian subcontinent, 8.9% Far East, 37.2% non-EU Europe (including Russia), 19.1% North America, see Eurostat, ‘Air Transport Statistics’ (November 2016) available at <ec.europa.eu/eurostat/statistics-explained/index.php/Air_transport_statistics> accessed 19 October 2017.

4 See among others Gostin, LO and Sridhar, D, “Global Health and the Law” (2014) 318 New England Journal of Medicine 1732 Google Scholar; Fidler, D and Gostin, L, Biosecurity in the Global Age: Biological Weapons, Public Health, and the Rule of Law (Stanford, 2007)Google Scholar.

5 On the general role of WHO see, for example, Gostin, L, Global Health Law (Harvard University Press, 2014)Google Scholar.

6 “Epidemics” in WHO, “Glossary of Humanitarian Terms” (2008), available at <www.who.int/hac/about/reliefweb-aug2008.pdf?ua=1>, accessed 19 October 2017.

7 Kelly, H, “The Classical Definition of a Pandemic is Not Elusive” (2011) 89 Bulletin of the World Health Organization 540 CrossRefGoogle ScholarPubMed; see also Last, JM (ed), A Dictionary of Epidemiology, 4th edn (Oxford University Press, 2001)Google Scholar.

8 A Public Health Emergency of International Concern (PHEIC) is declared by the Director-General of the WHO pursuant to the International Health Regulations IHR (2005) and is defined as: “an extraordinary event which is determined […] i. to constitute a public health threat to other States through the international spread of disease; and ii. To potentially require a coordinated international response.”

9 See section 2 below on the EU regulatory framework for PED vaccines.

10 WHO, International Health Regulations (2005) 2nd edn (Geneva 2008), available at <www.who.int/ihr/publications/9789241596664/en/>, accessed 19 October 2017.

11 See WHO Core Functions in Emergencies Preparedness and Response, IHR (2005); on rapid response mechanisms see also the Global Outbreak Alert and Response Network (GOARN) at <www.who.int/ihr/alert_and_response/outbreak-network/en/>, accessed 19 October 2017.

12 Taubenberger, JK, Morens, DM et al., “Influenza: the Mother of all Pandemics” (2006) 12 Emerging Infectious Diseases 15 CrossRefGoogle ScholarPubMed.

13 For an overview of GAP see Palkonyay, L and Fatima, H, “A Decade of Adaptation: Regulatory Contributions of the World Health Organization to the Global Action Plan for Influenza Vaccines (2006–2016)” (2016) 34 Vaccine 5414 Google Scholar.

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15 ibid, and J-A Rottingen, D Goulas et al., “New Vaccines against Epidemic Infectious Diseases” (2017) New England Journal of Medicine DOI 10.1056/NEJMp1613577.

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17 Fineberg, supra, note 14, 1336–1337.

18 In the space of one year the A-H1N1 virus had killed approximately 18,000 people globally, which is about 4% of the 250,000 to 500,000 annual deaths caused by “regular” influenza: see WHO Fact Sheet Communication fn 211, April 2009.

19 The contracts between producers and Member States in the EU for the sale and distribution of A-H1N1 vaccine were characterised, Europe-wide, by the explicit provision of liability exemption clauses. See also Orenstein, D, “When Law is Not Law: Setting Aside Legal Provisions During Declared Emergencies” (2013) 41 Journal of Law Medicine and Ethics 73 Google Scholar.

20 WHO, “An R&D Blueprint to Action to Prevent Epidemics: Accelerating R&D and Saving Lives” (2015) available at <www.who.int/blueprint/about/brochure-2017.pdf>, accessed 19 October 2017.

21 WHO, “Emergency Use Assessment and Listing Procedure (EUAL) for Candidate Vaccines for Use in the Context of Public health Emergency” (2015) available at <www.who.int/medicines/news/EUAL-vaccines_7July2015_MS.pdf>, accessed 19 October 2017.

22 See very recently FDA new release on Mutual Recognition of 2 March 2017, available at <www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm>, accessed 19 October 2017.

23 Both SADC and GCC are currently in the process of adopting vaccine registration guidelines based on EMA and FDA model under the umbrella of ICH.

24 Further details on AVAREF see Akanmori, B et al., “Regulatory Collaboration: The African Vaccine Regulatory Forum (AVAREF): A Platform for Collaboration in a Public Health Emergency” (2015) 29 WHO Drug Information 127, available at <apps.who.int/medicinedocs/documents/s22001en/s22001en.pdf>, accessed 19 October 2017Google Scholar.

25 WHO, “Identifying Regulatory Gaps” (2017) available at <www.who.int/csr/research-and-development/identifying_regulatory_gaps.pdf>, accessed 19 October 2017; Rottingen, supra, note 15, 611–612; J Cohen, “As Ebola Outbreak Grows, Question of Using Vaccine Becomes more Urgent” (2017) Science, available at <www.sciencemag.org/news/2017/05/ebola-outbreak-grows-question-using-vaccine-becomes-more-urgent>, accessed 19 October 2017.

26 Formerly known as the International Conference on Harmonisation of Technical requirements for Registration of Pharmaceuticals for Human Use, more information available at <www.ich.org> accessed 19 October 2017.

27 The original six founding members of ICH were the regulatory agencies of EU, USA and Japan, and respective regional associations representative of the pharmaceutical industry.

28 This is further discussed below in Part IV.

29 Council Directive 2001/83/EEC on the Community Code relating to medicinal product for human use, OJ 2001 L311.

30 Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products, OJ 2008 L334.

31 Decision No 1082/2013/EU of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 2119/98/EC, OJ 2013 L293.

32 Detailed description of the mock-up and emergency procedures see EMA, “Authorisation Procedures” available at <www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/q_and_a/q_and_a_detail_000080.jsp>, accessed 19 October 2017.

33 Regulation (EC) No 851/2004 of the European Parliament and of the Council establishing a European Centre for Disease Prevention and Control, OJ 2004 L142.

34 Commission Decision 2000/57/EC on the Early Warning and Response System for the Prevention and Control of Communicable Diseases under Decision No 2119/98/EC of the European Parliament and of the Council, OJ 2000 L21.

35 Specifically where Art 168 allows the EU to complement national policies in a series of situations including “monitoring, early warning and combating serious cross-border threats to health”.

36 Yen, C et al., “The Development of Global Vaccine Stockpiles” (2015) 15 The Lancet 340 Google Scholar; Tully, C et al., “Emergency Ebola Response: A new Approach to the Rapid Design and Development of Vaccines against Emerging Diseases” (2015) 15 The Lancet 356 Google Scholar; Fineberg, supra, note 14; WHO, supra, note 20.

37 Fineberg, supra, note 14; Treanor, J, “Influenza Vaccination” (2016) 375 New England Journal of Medicine 1261 Google Scholar.

38 Moon, S et al., “Will Ebola Change the Game? Ten Essential Reforms before the Next Pandemic. The Report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola” (2015) 386 The Lancet 2204 Google Scholar.

39 ibid.

40 ibid.

41 ibid.

42 ibid.

43 WHO, EUAL, supra, note 21.

44 WHO, ICMRA, supra, note 16; WHO, Regulatory Gaps, supra, note 25.

45 Kieny, M-P and Rägo, L, “Regulatory Policy for Research and Development of Vaccines for Public Health Emergencies” (2016) 15 Expert Review of Vaccines 1075 Google Scholar.

46 ibid 1076.

47 ibid.

48 WHO, “WHO Target Product Profiles for Lass Virus Vaccine” (2017) available at <www.who.int/blueprint/priority-diseases/key-action/lassa-fever/en/>, accessed 19 October 2017.

49 Moon, supra, note 38; Farrar, J and Piot, P, “The Ebola Emergency – Immediate Action, Ongoing Strategy” (2014) 371 New England Journal of Medicine 1545 Google Scholar.

50 EMA, “Vaccine for pandemic Influenza”, regularly updated and available at <www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000462.jsp&mid=WC0b01ac058004b9ac>, accessed 19 October 2017.

51 Art 21 of Regulation (EC) 1234/2008 explicitly refers to “Pandemic situation with respect to human influenza”.

52 See supra, note 3.

53 Fauci, A, “Ebola – Underscoring the Global Disparities in Healthcare Resources” (2014) 371 New England Journal of Medicine 1084 Google Scholar.

54 See, for example, Chapters II (Planning), III (Epidemiological Surveillance and Ad Hoc Monitoring) and IV (Early Warning and Response) of the Health Threats Decision.

55 Kieny and Rägo, supra, note 45, 1076 observe that an element that remains problematic for the conduction of clinical trials for Lassa fever vaccines under the WHO R&D blueprint is the difficulty in finding adequate funding – “A key issue remains who will pay for clinical trials.”

56 The United States President’s Emergency Plan for AIDS Relief (PEPFAR), more information is available at <www.pepfar.gov>, accessed 19 October 2017.

57 See, for example, the work of French sociologists Chateauraynaud, Francis and Torny, Didier, Les Sombres précurseurs: Une Sociologie pragmatique de l’alerte et du risqué (EHESS, 1999)Google Scholar; and Chateauraynaud, Francis, “La Sociologie pragmatique à l'épreuve des risques – Exercice de crise sur le dossier nucléaire” (1998) 44 Politix 76 Google Scholar, the central argument being that the weaknesses of physiological societal dynamics are better explained through pathological outbreaks.

58 The Swine Flu crisis is well explained by Fineberg, H, “Pandemic Preparedness and Response – Lessons from the H1N1 Influenza of 2009” (2014) 370 New England Journal of Medicine 1335 Google Scholar, at 1340.

59 The New Approach to goods is an EU-designed architecture whereby directives or regulation lay a framework without tackling technical details that are left to standardisation, certification and monitoring bodies (often private), for an explanation of the New Approach in an adjacent field involving health products see Van Leuven, B, “PIP Breast Implants, the EU’s New Approach for Goods and Market Surveillance by Notified Bodies” (2014) 5 EJRR 338 Google Scholar; Shepel, H, The Constitution of Private Governance – Product Standards in the Regulation of Integrating Markets (Hart, 2005)Google Scholar; Schepel, H, “The New Approach to the New Approach: the Juridification of Harmonized Standards in EU Law” (2013) 12 Maastricht Journal of European and Comparative Law 521 Google Scholar.

60 Rizzi, M, “Non-Measurable Negotiations: The EU between Transnational Pharmaceutical Regulation and Private Law” in M Cremona and H-W Micklitz (eds.), Private Law in the External Relations of the EU (Oxford University Press, 2016)Google Scholar.

61 Up to now the “Formal ICH Procedure” has consisted of five steps of consensus-building towards the adoption of new guidelines involving: (i) the adoption of a preliminary technical document; (ii) the adoption by regulatory members of the ICH of a preliminary guideline; (iii) round of consultation with regional agencies of regulatory members; (iv) adoption of finalised guidelines by ICH and (v) implementation. While ICH is undergoing a process of restructuring, it appears that the “Formal Procedure” will be maintained, though it is not yet clear whether it will be modified, see <www.ich.org/products/process-of-harmonisation.html>, accessed 19 October 2017.

62 Rizzi, supra, note 60, 284–285.

63 Minutes of the Management Committee for 2016 are available at <www.ich.org/meetings/management-committee.html>, accessed 19 October 2017 and the Minutes of the Assembly for 2015 and 2016 are available at <www.ich.org/meetings/assemblyreports.html>, accessed 19 October 2017.

64 Specifically: Brazil, South Korea and Switzerland are now regulatory members alongside the original founding members EU, USA and Japan, as well as two new organisations representing branches of the industry, see <www.ich.org/about/organisation-of-ich.html>, accessed 19 October 2017.

65 See again Rizzi, supra, note 60; and for a more generalist analysis of the problem of transnational opacity damaging EU internal transparency (and generally good governance standards) see Mendes, J, “EU and Global Regulatory Regimes: Hollowing Out Procedural Standards?” (2012) 10 International Journal of Constitutional Law 988 Google Scholar

66 The Tripartite Guideline ICH E2E on “Pharmacovigilance Planning” is available at <www.ich.org/products/guidelines/efficacy/efficacy-single/article/pharmacovigilance-planning.html>, accessed 19 October 2017. This guideline is particularly significant for the purposes of vaccines and in particular emergency vaccines as it lays the standards for early post-marketing surveillance periods of newly-marketed products.

67 Rizzi, supra, note 60, 283–290.

68 On the impact of securitisation on allocation of resources see Flear, M, Governing Public Health: EU Law, Regulation and Biopolitics (Bloomsbury, 2015)Google Scholar.

69 Abazi, V and Tauschinsky, E, “Reasons of Control and Trust: Grounding the Public Need for Transparency in the European Union” (2015) 11 Utrecht Law Review 78 Google Scholar.

70 Enemark, C, Biosecurity Dilemmas – Dreaded Diseases, Ethical Responses, and the Health of Nations (Georgetown University Press 2017)Google Scholar.

71 Mazzucato, M, The Entrepreneurial State (Demos, 2011)CrossRefGoogle Scholar.