Written evidence submitted by Emergent BioSolutions Inc.

 

1.              This evidence is provided by Emergent BioSolutions Inc. (“Emergent”), which is a global life sciences company whose mission is to protect and enhance life by focusing on providing specialty products, including medical countermeasures for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats. Emergent has a long-standing history of partnering with the United States and international governments to support the development of preparedness strategies and medical countermeasure stockpiles. Emergent had previously submitted written evidence in the last Parliament to the previous Committee’s examination of biosecurity. This response is submitted in addition to our written evidence provided in September 2019 and directly addresses the issues raised in the Committee’s updated call for evidence.  In submitting this evidence, we seek to draw the Committee’s attention to the experience of other countries.

 

2.              Whilst no nation was well-prepared for COVID-19, there are examples of best practice which might interest the Committee.  In summary this document focuses on the identification and categorisation of the main drivers of biosecurity risks, the monitoring of such risks, preparedness planning, including the need to stockpile, and the manner in which the public and private sectors can work to maximise cross-government benefit which might help inform a review of the fusion doctrine.

 

Main Drivers of Biosecurity Risks

 

3.              There are multiple drivers of biosecurity risks to human health in the United Kingdom. COVID-19 is currently at the forefront of biosecurity risks to human health in the UK; it is likely to remain there for the foreseeable future.  The global impact from COVID-19, both on human health and the global economy, demonstrates the scale of the risk that the world faces from naturally occurring pathogens. The World Health Organisation’s Priority Disease list identifies some of the most significant threats, including Disease X’, which the WHO define as “the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease.[1] Indeed, COVID-19 could be considered as an example of Disease X.

 

4.              The European Medical Agency (EMA)[2] and the United States Centers for Disease Control and Prevention (CDC)[3] categorize threats slightly differently, but both agencies categorize anthrax, botulism, plague, smallpox and viral haemorrhagic fevers amongst the biological agents that are the highest priority in relation to national security risk. 

 

5.              Other drivers of biosecurity risk that are of increasing concern include the potential for synthetic biologies to be misused and the threat of bioterrorism.  Very recently, the United Nations Secretary General, NATO’s Secretary General and the Council of Europe have all highlighted that the threat from terrorism, including bioterrorism, has increased as a result of the preparedness gaps that COVID-19 has exposed.[4]  In March 2020 a German court sentenced a Tunisian man (and Islamic State sympathizer) to 10 years in prison for planning a biological attack involving ricin.[5] The threat to human health from chemical weapons was highlighted in the 2018 Salisbury attack.[6] The preparedness gaps exposed during the COVID-19 pandemic illustrate that the UK, along with many other countries, may be vulnerable to similar threats in the future unless lessons are learnt and strategic preparedness is improved.

 

Monitoring of Biosecurity Risks

6.              Since 2018, a number of international organisations have highlighted the growing risk posed by public health threats, whether naturally occurring, accidental or deliberate. They have also articulated some significant concerns over strategic preparedness to respond to these threats.

 

7.              In January 2019, the World Economic Forum (WEF) published its annual Global Risk Report, in which it stated the following:

 

Changes in how we live have increased the risk of a devastating outbreak occurring naturally, while emerging technologies make it increasingly easy for new biological threats to be manufactured and released—either deliberately or by accident. The world is badly under-prepared for even modest biological threats. We are vulnerable to potentially huge impacts on individual lives, societal well-being, economic activity and national security.”[7]

In identifying how biological risks are evolving both in nature and in laboratories, the WEF’s report sounded a clarion alarm, highlighting the potential cost of a global pandemic together with global preparedness gaps. Gaps identified by the WEF included: under-funding of vaccine development; weaknesses of basic preparedness in individual countries; and poor global governance.

 

8.              In October 2019, the Global Heath Security Index published its first report. The opening paragraph is striking in light of COVID-19:

 

“Biological threats—natural, intentional, or accidental—in any country can pose risks to global health, international security, and the worldwide economy. Because infectious diseases know no borders, all countries must prioritize and exercise the capabilities required to prevent, detect, and rapidly respond to public health emergencies. Every country also must be transparent about its capabilities to assure neighbors it can stop an outbreak from becoming an international catastrophe. In turn, global leaders and international organizations bear a collective responsibility for developing and maintaining robust global capability to counter infectious disease threats. This capability includes ensuring that financing is available to fill gaps in epidemic and pandemic preparedness. These steps will save lives and achieve a safer and more secure world.”[8]

 

The report’s overall finding is that “National health security is fundamentally weak around the world. No country is fully prepared for epidemics or pandemics, and every country has important gaps to address.”[9]

 

9.              It is clear that biosecurity risks from naturally occurring public health threats, as well as man-made biological and chemical threats, had been clearly identified by both international organisations and individual countries prior to COVID-19.  Yet COVID-19 demonstrates that the international community had not taken adequate measures to treat these risks through strategic preparedness.

 

Domestic Preparedness

 

10.              In considering the UK’s domestic preparedness for biosecurity, it is important that any preparedness strategy protects against the most high-risk biological and chemical threats, and increases the nation’s resilience to deal with unexpected biological threats the unexpected (e.g., “Disease X”). The UK Government’s 2018 Biological Security Strategy states that “we maintain appropriate stockpiles of clinical countermeasures for diseases of concern (whether outbreaks are caused naturally or deliberately)[10]. Whilst other governments, such as the United States, routinely publish details on medical countermeasures stockpiling, the UK government does not. We suggest that the Committee consider whether the UK strategic national stockpile is appropriately resourced with medical countermeasures to respond to the full range of potential public health threats – naturally occurring and deliberate; whether robust plans are in place to replace stock that is used, or whose shelf-life is due to expire; and whether greater transparency of the strategic national stockpile would increase both confidence and accountability in the government’s strategic preparedness.

 

Fusion Doctrine in support of Strategic Preparedness to respond to Biological and Chemical Threats

 

11.               The 2018 National Security Capability Review identified that the government had added “diseases and natural hazards affecting the UK[11] to the challenges likely to drive UK security priorities. From the perspective of strategic preparedness, it is important to consider whether medical countermeasures against both biological and chemical agents are readily available to protect the general public, frontline healthcare providers, the Emergency Services, and the Armed Forces. The risk to the Emergency Services from novel agents was graphically demonstrated in the Salisbury attack. 

 

12.              The Fusion Doctrine provides an opportunity to manage medical countermeasure capabilities across government departments so that they are available to all front-line responders. A significant benefit of such coordination and collaboration is that some types of medical countermeasures, such as personal protective equipment (PPE), vaccines and post-exposure decontaminants, can be routinely rotated out of the stockpile and forward deployed to frontline healthcare providers, the Emergency Services and the military before they reach the end of their shelf-life.  

 

13.              COVID-19 has highlighted a number of issues with sourcing medical supplies during a pandemic. Just-In-Time supply chains can quickly become overmatched by global demand and logistic constraints. The Fusion Doctrine rightly proposes that such challenges are best addressed through partnerships between the public and private sector, prior, during and after health security events. This is particularly true in relation to the development and supply of medical countermeasures, including vaccines and therapeutic drugs. Long-term strategic partnerships between government and industry provide a valuable and cost-effective solution to building up and maintaining a robust strategic stockpile over time.  Security of supply chains, collaborative R&D investment, the shared ownership of risk, access to manufacturing innovation and economies of scale are some of the benefits.

 

Conclusion

 

14.              Our previous evidence stated that Emergent works with the United States government to fulfil strategic national stockpile requirements, support the development and regulation of medical countermeasures and operate one of three Centers for Innovation in Advanced Development and Manufacturing. In collaboration with international partners, this flexible manufacturing capability with its surge-capacity is proving to be a vital national asset for the development and manufacture of COVID-19 vaccine candidates in the United States.  Emergent would welcome the opportunity to similarly work with the UK government to address its strategic preparedness and medical countermeasure requirements.

 

22 June 2020


[1] World Health Org., R&D Blueprint: List of Blueprint Priority Diseases. Available at: http://origin.who.int/blueprint/priority-diseases/en/.

[2] European Medical Agency, Human Regulatory: Biological and Chemical Threats. Available at: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/biological-chemical-threats.

[3] US Centers. for Disease Control & Prevention, Emergency Preparedness and Response: Bioterrorism Agents/Disease (last reviewed Apr. 4, 2018), https://emergency.cdc.gov/agent/agentlist-category.asp.

[4] UN News. COVID-19 threatening global peace and security, UN chief warns.  Available at: https://news.un.org/en/story/2020/04/1061502

NATO Press Conference following the virtual meeting of the North Atlantic Council in Defence Ministers’ session. Available at: https://www.nato.int/cps/en/natohq/opinions_175087.htm.  

Council of Europe continues working to enhance international co-operation against terrorism, including bioterrorism.  Available at: https://www.coe.int/en/web/counter-terrorism/-/covid-19-pandemic-the-secretariat-of-the-committee-on-counter-terrorism-warns-against-the-risk-of-bioterrorism.

[5] The Journal; of Counter-Terrorism and Homeland Security International, 2020, German Ricin Bomb Plot Conviction Highlights Non-Conventional Terror Threats. Available at: https://iacspjournal.com/regional-europe/german-ricin-bomb-plot-conviction-highlights-non-conventional-terror-threats

[6] The Telegraph, How the Salisbury poisoning prepared us for a pandemic, 16 June 2020. Available at: https://www.telegraph.co.uk/news/2020/06/16/salisbury-poisonings-bbc-pandemic/

[7] World Economic Forum, The Global Risks Report 2019, p45-46. Available at:

[8] NTI / Johns Hopkins Centre for Health Security, Global Health Security Index, 2019, p5.  Available at https://www.ghsindex.org/report-model/

[9] Ibid, p5.

[10] HMG, UK Biological Security Strategy, 2018, p26.  Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/730213/2018_UK_Biological_Security_Strategy.pdf

[11] HMG, National Security Capability Review, 2018, p.6.  Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/705347/6.4391_CO_National-Security-Review_web.pdf