A report of the fourth meeting of the New Defence Agenda’s Bioterrorism Reporting Group co-organised with the Chemical and Biological Arms Control Institute (CBACI)
Countering Bioterrorism: How can Europe and the United States work together?
Théâtre de la Résidence, Brussels 25 April 2005 The views expressed in this report are personal opinions and not necessarily the views of the organisations they represent, nor of the New Defence Agenda or the Chemical and Biological Arms Control Institute, their Boards of Trustees, members or sponsors.
Reproduction in whole or in part is permitted, providing that full attribution is made to the New Defence Agenda and to the source(s) in question, and provided that any such reproduction, whether in whole or in part, is not sold unless incorporated in other works.
Countering Bioterrorism: How can Europe and the United States work together?
A report of the fourth meeting of the New Defence Agenda’s Bioterrorism Reporting Group co-organised with the Chemical and Biological Arms Control Institute (CBACI)
Théâtre de la Résidence, 25 April 2005
With the support of Acambis & Agilent Technologies
Editor: Giles Merritt Editorial Coordinator: Jessica Henderson Editorial Assistant: Hendrik Roggen Rapporteur: John Chapman Design & Production: AOVO DESIGN, www.aovo.net Contents
INTRODUCTION ...... 4 Giles Merritt, Director, New Defence Agenda Michael Moodie, President, Chemical and Biological Arms Control Institute
Recommendations ...... 6
APRIL 25 Programme ...... 10
List of participants ...... 12
EXECUTIVE SUMMARY ...... 15
Analysis ...... 35 Jill Dekker-Bellamy, Bio-Defence Consultant, New Defence Agenda
Participant Contributions Ian Abbott ...... 47 Georges Benjamin ...... 49 Gerald Epstein ...... 52 David Franz ...... 55 Randall Murch ...... 60 Florin Paul ...... 63 Frank Rapoport ...... 65 future programmes ...... 68
About the NDA ...... 71
About the CBACI ...... 72 Introduction Introduction by Giles Merritt by Michael Moodie
The NDA is proud to present the third This report offers a summary of the debates, It has become common place to note that common policy concepts and assumptions, of its Bioterrorism Group reports. together with additional contributions from the promotion of domestic security must be similar language for communicating, and Some 80 experts from both sides of the speakers. The main purpose of these reports conducted on a global basis. It is nevertheless a mutual set of policy tools proved invaluable Atlantic gathered in Brussels on April 25 is to offer recommendations that can push true. The security challenge posed by the in overcoming differences and building an potential misuse of the life sciences is beyond to discuss common strategies to counter the political process forward towards enduring security architecture. That sort of the capability of any single state to address collaborative perspective now must find a bioterrorism. The trustful partnership the adoption of a global and commonly on its own. Failure to contain an infectious place in the biological arena. between the NDA and the Chemical and accepted counter-bioterrorism strategy. agent in any single place could result in an Biological Arms Control Institute (CBACI) attack widening across the globe. The need The Chemical and Biological Arms Control provided the basis for a frank discussion that The impact of these NDA meetings reflects to provide essential countermeasures stems Institute was honored to co-sponsor with is part of a continuing process of creating a the willingness of participants to take an from the fact that the problem does not the New Defence Agenda the dialogue transatlantic dialogue on bioterrorism. active part in the discussions. This report recognize international borders, and that between Europe and the United States is intended to circulate new ideas to the solutions are beyond the resources of any that is reflected in these pages. We believe The nature of the bio-threat is that NDA’s network of experts, and offers an single country. that it made an important contribution to counter-measures cannot be developed opportunity to register their support for its better understanding and the creation of a by the EU or US alone; it is a joint problem recommendations. I should therefore like The United States and Europe must work foundation on which we must continue to with each other if they are to meet this that needs joint solutions. The meeting to thank NDA’s supporters and encourage build cooperative efforts. We look forward challenge and foster more secure societies. to working with the NDA on additional showed that there are still many hurdles interested parties to contact us with their Unfortunately, the biological challenge is efforts in the future. to be overcome before we can arrive at a views on future topics that they feel need relatively new, and neither a commonly common strategy. The NDA Bioterrorism attention. accepted view of the problem nor a shared Europe and the United States need each Reporting Group will continue to gather key strategy or set of policies to respond other today no less than in the darkest days players to push the debate inside Europe, effectively characterizes perceptions on of the Cold War. The challenge is as difficult, and also looks forward to strengthening Giles Merritt the two sides of the Atlantic. Significant if not more so, and the ground on which we transatlantic ties. Director, New Defence Agenda differences continue to exist about both the must operate is often unfamiliar. But if we nature of the challenge and the appropriate continue to learn from one another, to work set of policy responses. together, and to appreciate the outcomes that collaboration will yield, we will be in a much These differences must be overcome. Europe stronger posture to meet the dangers ahead. and the United States have successfully countered threats to their shared interests and values by developing a strategy that identified enough common ground in Michael Moodie which to work together. There was no shortage of disagreements, but the shared President, Chemical and Biological (if not unanimous) views of the problem of Arms Control Institute Recommendations Signatories to the Recommendations*
Seven Recommendations following the 4th meeting of the NDA’s Bioterrorism Reporting Vyacheslav Abramov Krzysztof Chomiczewski Group on 25 April, 2005* Head of the Department of Biochemistry and Head of the Division on Protection against Immunity, Institute of Immunological Engineering, Bioterrorism, Military Institute of Hygiene and Russia Epidemiology, Poland
Conduct a joint risk assessment to determine the plausible risk envelope for bio-terrorism Sebastien Alauzet Miloje Cobeljic that will guide planning and resource allocation decisions; Project Manager Director, Institute of Epidemiology Antidote Pharma Military Medical Academy, Bulgaria Camille de Walder Based on the risk assessment, identify the priority requirements and capabilities necessary Ken Alibek Program Manager, U.S. Civilian Research and Executive Director for Education & Science Development Foundation to implement an integrated bio-defence strategy that incorporates elements of deterrence, George Mason University, US prevention, preparedness, and consequence management/mitigation; Christian Devaux Derek Averre Directeur, Département Sciences de la Vie Senior Research Fellow Centre National de la Recherche Scientifique Improve interoperability between core bio-defence and security agencies to combat University of Birmingham, UK (CNRS), France threats to transatlantic security; Shakhnoza Azimova Toon Digneffe Director, Institute for Chemistry of Plant Government Affairs Manager, Baxter Substances, Uzbekistan Agree upon a protocol and strategy for counter-measures, delegate leadership areas and Mehmet Doganay Agoritsa Baka Head of Department of Infectious Diseases define responsibilities before an act of bio-terrorism; Head of the Biological & Toxic Hazards Office Erciyes University, Turkey Hellenic Center for Infectious Disease Control, Greece Bruno Dupré Harmonize national European policies to strengthen bi-lateral and multi-lateral counter- Head of the Non Proliferation and Disarmament Bureau, Ministère de la de Défense, France terrorism and proliferation cooperation at the European as well as international level; Maurizio Barbeschi Scientist, United Nations World Health Gerald Epstein Organisation (WHO) Senior Fellow for Science and Security, Homeland Adopt a more integrated transnational approach to public health security, bio-terrorism Security Program, Center for Strategic and Georges Benjamin International Studies (CSIS), US and emerging disease preparedness, detection, surveillance, containment and response; Executive Director American Public Health Association Myron D. Fottler Professor and Executive Director of Health Services Increase the selection of counter-measures and capability sharing; develop formal Katrin Bernard Administration Programs mechanisms to share lessons learned. Head of BioSafety, Institute of Virology and University of Central Florida, US Immunoprophylaxis, Switzerland David Franz Thomas Binz Chief Biological Scientist * The recommendations stemming from the NDA Bioterrorism Reporting Group are Head Biosafety Midwest Research Institute, US developed after each meeting based on the discussions held and the suggestions brought Swiss Federal Office of Public Health Jeffrey Gelfand up on the day. Recommendations are then floated to a wide pool of bioterrorism, security Paulo Brito Director, CIMIT International and defence experts to sign on to. Assistant Secretary to the Defence Committee Massachusetts General Hospital, US Assembly of the Western European Union Manfred Green Director, Israel Center for Disease Control Tim Brooks Head of Novel & Dangerous Pathogens Gert Harigel Health Protection Agency Porton Down, UK Senior Physicist, European Organization for Nuclear Research (CERN) Robert Mark L. Buller Professor of Molecular Microbiology and John Haurum Immunology, Saint Louis University, US Chief Scientific Officer, Symphogen
NEW DEFENCE AGENDA
James R. Holmes Yuri V. Remnev Additional recommendations from Senior Research Associate Deputy Director, Center of Modern Medical University of Georgia, US Technology, TEMPO, Russia
Andras Huszar Roger Roffey experts in the field Head of Health Coordination Office Swedish Defence Research Agency (FOI) Ministry of Interior Affairs, Hungary Liene Indriksone James A. Roth Here are some of the additional recommendations the NDA received after distributing its Counsellor - Ministry of Interior Director, Center for Food Security and Public Permanent Representation of Latvia to the EU Health, Iowa State University, US recommendations to experts in the field: Cyril Klement Jan Rozing Head Information Centre for Bacteriological Weapons Former Deputy Head DPO-Biology Develop technical and regulatory approaches for radically accelerating the development Regional Institute of Public Health, Slovakia United Nations Monitoring, Verification and Inspection Commission (UNMOVIC) of biodefence drugs and vaccines to counter bioengineered threat agents for which Erika Mann effective prophylactics and therapeutics do not currently exist; Member, European Parliament Leonid Ryabikhin Executive Secretary, Center for Scientific Research John Martin Committee of Scientists for Global Security, Improve European capabilities in the area of bio-defence based on NATO core assets as Director, United Nations World Health Russia Organisation (WHO), Brussels CBRN capabilities and on EC initiatives as RAS-BICHAT and promote closer cooperation Márta Melles Karl-Heinz Schleifer between EU and NATO in this area; General Director Head Department of Microbiology National Center for Epidemiology, Hungary Technische Universität München, Germany Promote and conduct regular transnational training courses and exercises using if Steven Monblatt Dany Shoham Executive Secretary Senior Research Associate, Begin-Sadat (BESA) necessary NATO and EU established mechanisms and structures in this area as well as Organization of American States (OAS) Center for Strategic Studies, Israel relying on their expertise;
Stephen A. Morse René Snacken Associate Director for Science, Bioterrorism Director, Head of the Department Epidemiology- Focus on source prevention, emphasise the importance of the Bio Convention in Preparedness and Response Program Toxiology National Center for Infectious Diseases, US Belgian Scientific Institute of Public Health third countries, guide the experts in these countries and criminalise acts against the Randall Murch Convention; Associate Director for Research Program Natalya Tomarovskaya Development, Virginia Tech-National Capital Head of Branch Office, International Science & Region Operations, US Technology Center (ISTC), Russia Develop an effective public information campaign that prepares the public regarding the threat and measures that may be needed following an event as part of the crisis Maarten S. Nieuwenhuizen Jonathan Tucker Business Unit Chemical and Biological Protection Director, Chemical and Biological Weapons management response and the consequence management in order to maintain any TNO Prins Maurits Laboratory Nonproliferation Program Center for Nonproliferation Studies (CNS), US affected areas of the critical national infrastructure. Florin N. Paul Deputy Surgeon General Dean Wilkening Ministry of Defence, Romania Director, Science Program Stanford University, US Renaat Peleman Chief Medical Officer Ghent University, Belgium Raymond Zilinskas Director, Chemical and Biological Weapons Natasha Polyanskaya Nonproliferation Program Operations Manager of the Novel and Dangerous Center for Nonproliferation Studies (CNS), US Pathogens Department Health Protection Agency Porton Down, UK *The signatories of these recommendations have signed in their personal capacities and Frank Rapoport do not necessarily represent the views of the Partner, McKenna Long & Aldridge organisations they represent.
NEW DEFENCE AGENDA Programme of the April 25 meeting
Session 1: Can we develop a transatlantic response to bioterrorism? Session II: What future for bio-defence industry and technologies?
The recent Atlantic Storm simulation exercise showed the United States and EU Member States As the EU develops its policies to prevent bio-terrorism and strengthen public health security, what are not prepared for a bioterrorism attack. With US and EU biodefence programmes varying role will technology play in the identification and detection of pathogens and agents? What is the markedly, can the Atlantic alliance develop suitable defences together? Are differences in EU and future of the European biotechnology sector and its specific bioterror applications? In which defence US programmes based purely on threat perception, or are other critical factors involved? What technology areas should the EU and US be consolidating technology acquisition and are advances in are the similarities and differences between European and American programmes and do gaps the life sciences affecting the ability of bio-defence companies to counter bio-terrorism? Are there in scope and scale, priorities and strategy weaken transatlantic defence cooperation? As past sufficient opportunities for collaboration, sharing of information, the exchange of lessons learned and preparedness programmes were developed around state-run bio programmes, will the potential best practices between the EU and the United States on issues of civilian bio-defence? How should increase of sub-state actors affect our attempts to control biological weapons development and the US and EU industries work together to avoid duplicating research? use? If the EU should strengthen its homeland security infrastructure, does that mean developing something similar to the US Department of Homeland Security’s National Response Plan? Moderators: Michael Moodie, President, Chemical and Biological Arms Control Institute Introduction: Frank Rapoport, Partner, McKenna Long & Aldridge Jill Dekker-Bellamy, Bio-defence consultant, New Defence Agenda
Panelists: Moderators: Randall Murch, Associate Director, Research Programs at Virginia Tech and former Director Giles Merritt, Director, New Defence Agenda of Advanced Systems and Concepts Office at the Defence Threat Reduction Agency Michael Moodie, President, Chemical and Biological Arms Control Institute Florin Paul, Deputy Surgeon General, Ministry of Defence, Romania Gerald Epstein, Senior Fellow for Science and Security, Homeland Security Program, Center for Strategic and International Studies (CSIS) Panelists: Georges Benjamin, Executive Director of the American Public Health Association David Franz, Senior Scientist at the Midwest Research Institute and former Commander at USAMRIID Annalisa Giannella, Personal Representative of the High Representative for matters of non-proliferation, Council of the European Union Erika Mann, European Parliament and European representative to Atlantic Storm Brigadier Ian Abbott, Director Policy and Plans Division, European Union Military Staff
NEW DEFENCE AGENDA 11 Gerard Greene Milen Luytskanov Participants 25 April 2005 Counsellor Deputy Head of Mission and Deputy Permanent Embassy of Trinidad and Tobago to Belgium Representative to PSC Permanent Delegation of Bulgaria to NATO Katia Grimard Intern, Mission of Canada to the EU Aleš Macela Ian Abbott Krzysztof Chomiczewski Vice-Chancellor for Science Chief of Policy and Plans Division Head of the Division on Protection against Richard Guthrie University of Defence, Czech Republic European Union Military Staff Bioterrorism, Military Institute of Hygiene and Project Leader, Chemical and Biological Warfare Epidemiology, Poland Stockholm International Peace Research Stanislaw Majcherczyk Massimo Amadei Institute (SIPRI) Director, Regional Center of Prevention of Policy & Plans Division, European Union Military Staff Neil Davison Bioterrorism in Central and Eastern Europe, Poland Researcher, Disarmament Research Centre Daniel Hass Fathi Ayoub University of Bradford, United Kingdom Office Director, United States Air Force, Office Erika Mann Economic Counsellor, Mission of Libya to the EU of General Counsel Member, European Parliament Jean-Pierre De Cavel Joanna Azzi Chef de Service, Laboratoire de Haute Securité Rainer Hellmann Maurizio Martellini Secretary of the Mission Institut Pasteur de Lille, France Journalist, Fuchsbriefe Secretary General Mission of Lebanon to the EU Landau Network - Centro Volta, Italy Hans de Vreij Jessica Henderson Luis Balsells-Traver Security and Defence Editor (observer to the Project Manager, New Defence Agenda Executive Officer, Western European ‘Atlantic Storm’ exercise), Radio Netherlands John Martin Armaments Group (WEAG) Director, United Nations World Health Andras Huszar Organisation (WHO), Brussels Jill S. Dekker-Bellamy Head of Health Coordination Office Stuart Bell Bio-Defence Consultant, New Defence Agenda Ministry of Interior Affairs, Hungary DTRA Field Office Raphaël Mathieu Toon Digneffe Researcher Stanislaw Janczak Institut Royal Supérieur de Défense, Belgium Georges Benjamin Government Affairs Manager, Baxter Counsellor, Embassy of Poland to Belgium Executive Director Andrey Medvedev American Public Health Association Gerald Epstein Linda Karvinen Expert en Chef, Commercial Representation of Senior Fellow for Science and Security, Homeland Project Manager, New Defence Agenda Clemens Betzel Security Program, Center for Strategic and Russia to Belgium President, United Technologies International International Studies (CSIS), Washington D.C. Laszlo Kiss Giles Merritt Operations, Europe, United Technologies Transnational issues Task Force Director, New Defence Agenda Jan Foghelin European Union Military Staff Thomas Binz Head of Division, Defence Analysis Ruth Milligan Head Biosafety Swedish Defence Research Agency (FOI) Aleksandar Knezevic Swiss Federal Office of Public Health Second Secretary Financial Services Section Co-ordinator, EurActiv.com Maria Laura Franciosi Mission of Serbia and Montenegro to the EU Fiona Bottomley Freelance Journalist, Il Sole 24 Ore William Moens First Secretary, Permanent Representation of the Spyros Konidaris Deputy Head of Unit, Biotechnology and GMOs Unit, United Kingdom to the EU David Franz Advisor to the Deputy Director General European Commission, Joint Research Center Chief Biological Scientist Paulo Brito Midwest Research Institute, US European Commission, Directorate General for Michael Moodie Assistant Secretary to the Defence Committee Information Society President, The Chemical and Biological Arms Assembly of the Western European Union Helmut Ganser Control Institute (CBACI), Washington D.C. Defence Advisor, Delegation of Germany to NATO Victor Kulagin Geert Cami Counsellor Randall Murch Managing Director, New Defence Agenda Annalisa Giannella Embassy of the Russian Federation to Belgium Associate Director for Research Program Personal Representative of the High Development, Virginia Tech-National Capital John Chapman Representative for matters of non-proliferation Cornelia Kutzer Region Operations, US Rapporteur, New Defence Agenda Council of the European Union Senior Marketing Manager, Baxter Vaccine AG David Oppenheimer Finn Chemnitz Manfred Green Anna Löfgren Assistant to Maria Gomez MEP UNC, NATO Director, Israel Center for Disease Control Project Assistant, New Defence Agenda European Parliament
NEW DEFENCE AGENDA 13 Togan Oral Maurice Sanciaume Executive Summary First Secretary at the Directorate General for Director European Affairs, Agilent Technologies Security Affairs, Ministry of Foreign Affairs, Turkey Gennady Savostyuk Bioterrorism - a potent mixture of Olexander Parfyonov Counsellor on military questions First Secretary, Mission of Ukraine to the EU Mission of the Russian Federation to the EU “infectious disease and intent”
Jan Peter Paul Hocine Si Ahmed Adviser, European Commission, Directorate Military Attaché, Embassy of Algeria to Belgium General for Health & Consumer Protection The latest Bioterrorism Reporting Group the European side. The US has obvious David Smith meeting was hosted jointly by the NDA advantages in comparison to a 25 member Florin N. Paul President, World Federation for Culture Collections Deputy Surgeon General and CBACI, an example of excellent state - and expanding - EU, but NDA Ministry of Defence, Romania Andres Smith Serrano EU-US collaboration. If there was one Director Giles Merritt felt moved to External and Inter-Agency Affairs Officer, Office of Renaat Peleman conclusion that could be drawn from the ask who was accountable on the matter Chief Medical Officer, Ghent University, Belgium the Director-General United Nations Office at Geneva (UNOG) meeting itself, it was that such teamwork of addressing Europe’s bioterrorist threat. Natasha Polyanskaya had to be duplicated in the actual fight That was also a question of much interest Operations Manager of the Novel and Dangerous Mark Smolinski Pathogens Department, Health Protection Acting Vice President for Biological Programs against bioterrorism. Not that the event to the US participants and it was left to the Nuclear Threat Initiative (NTI), Washington D.C. Agency Porton Down, United Kingdom lacked ideas, as these were ever present. Council of the EU’s Annalisa Giannella Michael J. Powers Christian Sommade But there were few signs of real co- to answer the Henry Kissinger question Senior Fellow, The Chemical and Biological Arms Délégué General operation and the spectre of different – “If I want to pick up the phone and talk to Control Institute (CBACI), Washington D.C. Haut Comité Français pour la Défense Civile “threat perceptions” was forever hovering Europe, whom do I call?” Giannella did not Frank Rapoport Ronald Sullivan in the background. have the number and argued instead that Partner, McKenna Long & Aldridge NATO Business Development Manager, SAIC Science Applications International Corporation the new Constitution would deliver clearer Louis Réchaussat CBACI’s Michael Moodie set the scene by lines of responsibility. Director of Information System Department, French Jean Swings Institute of Health and Medical Research INSERM Past President arguing that on bioterrorism the traditional World Federation for Culture Collections transatlantic partnership did not exist insofar Another thorny issue under discussion was Barbara Rhode Head of Unit, Multilateral Cooperation, European Otger Tartera as there was neither a shared perception of that of public health information systems. Commission, Directorate General for Research Intern, Organization of American States (OAS), the challenge or an agreed strategy for dealing The EU Military Staff’s Brigadier Ian Abbott Washington D.C. Peter Roell with it. He had heard a lot of talk but seen wanted accountability to be defined in that Minister Counsellor Paul Thonon little action. Moodie was supported by MEP area, while Mann called for the responsible Permanent Representation of Germany to the EU President Cockerill Maintenance & Ingenierie Defence (CMI) Erika Mann, fresh from the Atlantic Storm authorities to show EU’s citizens they were Hendrik Roggen Project Assistant, New Defence Agenda exercise, who thought that current US – EU in control and that political management Brooks Tigner EU Correspondent, Defense News co-operation was fragmented. Mann wanted was in place. Not that the problems were Christine Rohde Collection Curator, Lab and Safety Supervisor a more coherent approach to be developed. limited to Europe. The American Public Malek Twal DSMZ - Deutsche Sammlung von The Polish Embassy’s Stanislaw Janczak, Health Association’s (APHA) Georges Mikroorganismen und Zellkulturen GmbH Deputy Head of Mission Embassy of Jordan to Belgium however, delivered the most damning Benjamin described an American public Jan Rozing comment. He simply stated that the US and health system that had made significant Former Deputy Head DPO-Biology Falco Verna United Nations Monitoring, Verification and Naval Attaché and Deputy Military Adviser the EU had to start to communicate. progress but still had laboratory facilities “in Inspection Commission (UNMOVIC) Permanent Representation of Italy to the EU a state of disrepair”, an ageing workforce Gustav Russ Jean Pascal Zanders Perhaps the other fundamental problem and a struggle with the private sector to Senior Scientist, Institute of Virology, Slovakia Director, BioWeapons Prevention Project (BWPP) identified was that of accountability on attract the right level of staff.
NEW DEFENCE AGENDA 15 As for the threat itself, Moodie, Virginia With Murch reasoning that scientific Session I Polytechnic Institute’s (Virginia Tech) knowledge was racing ahead at an enormous Randall Murch and Romanian Ministry of and unprecedented pace, it was left to Can we develop a transatlantic response Defence’s Florin Paul all wanted the same CSIS’s Gerald Epstein to conclude that to bioterrorism? level of attention focused on re-emerging “a flexible responsive adaptive programme” infectious diseases as was currently being had to be developed. He added that it placed on bioterrorism. Moodie’s view would be “a major challenge for both the New Defence Agenda Director Giles the more fundamental and subtle areas is that the bio challenge must be seen as US and Europe”. Merritt opened the meeting by stressing of risk communication, threat perception, a spectrum of risks that spans naturally the importance of the NDA’s new approach and response. She reasoned that occurring risk such as infectious disease As for the future, the Midwest Research partnership with the Chemical and threat reduction, arms control and non- on one end to potential deliberate misuse Institute’s David Franz agreed that Biological Arms Control Institute (CBACI). proliferation were all opportunities for the on the other. The NTI’s Mark Smolinski collaboration at existing levels was The transatlantic element was vital in any US, Canada and the EU to strengthen their was currently dealing with that particular insufficient. He wanted a “species neutral” discussion on bioterrorism, otherwise, collaboration. Dekker-Bellamy raised other situation, finding it difficult to explain to his approach and much greater exploitation Merritt conceded, one would be “fumbling key issues, such as: colleagues in the developing world why there of the genomics revolution. Franz had no around in the dark”. Looking forward to a were no resources available to fight malaria simple solution but he had a rallying cry for lively day’s debate, Merritt passed the floor who will lead the response? and TB, whereas the US government was US-EU collaboration – bioterrorism was “a to Jill Dekker-Bellamy. the US, Canada or the EU? promising billions of dollars via the BioShield mixture of infectious disease and intent” the one with the most resources? programme to combat anthrax, smallpox, and it had to be fought. the one with the best communication and other potential bioterrorism agents. Where to begin? system?
Dekker-Bellamy explained that the purpose how will the various agencies and of the meeting was to better understand institutions interact with one another? the challenges faced in preparing for and responding to terrorism and the Looking ahead to the second session, unconventional weapons use by terrorists. Dekker-Bellamy said that all governments She saw problems in creating a transatlantic were forced to confront several vital issues. partnership if the issues were approached These included the ability: from different perspectives, with different goals and different capabilities. to stop acts of bioterrorism to quickly communicate health and Describing the recent Atlantic Storm security information exercise, Dekker-Bellamy said it had to co-ordinate not only between revealed not only inadequacies in the agencies but also among governments preparedness for a smallpox outbreak to improve detection methods, where and lack of vaccine stockpiles, but also technology would play a critical role
See conclusions at http://www.atlantic-storm.org/analysis/initial.html
NEW DEFENCE AGENDA 17 Room for improvement 3. A single-factor approach is not sufficient: 1. A knowledge-based approach to combat- A list of lessons learned the issue must not be over-simplified, there ing bioterrorism: based on experience (as In his introduction, Michael Moodie, are various actors, agents, modes of opera- the US has suffered anthrax and salmo- David Franz, Senior Scientist at the President of the Chemical and Biological tion, targets (human, plant or animal, etc.). nella attacks) Midwest Research Institute and former Arms Control Institute, focused on the a. it is necessary to develop a range of Commander at USAMRIID, looked at the need to improve international collaboration. responses to combat varying threats 2. The necessity to fight a combination of history of bioterrorism and listed some of After making an unfavourable comparison “evil individuals and bad organisms” the lessons learnt: between the current transatlantic situation 4. Though permanent, the risk can be dimin- and that existing during the “Cold War”, he ished: via a multi-facetted approach (e.g. 3. Nature is the most dangerous terrorist 1. It is harder to protect civilians in everyday bemoaned today’s lack of a “shared intellec- norm building, deterrence, prevention, life than military personnel on the battlefield. tual infrastructure”. Outlining his thoughts, preparedness, consequence manage- 4. The work of the public health authority has Moodie described this infrastructure as one ment & mitigation). moved centre stage: it is now more vis- 2. Not all microbes are created equal. that should contain: ible and, by necessity, more proactive. Moodie concluded that a much wider- 3. Biological and chemical threats must be a shared view of the problems faced range of players had to be integrated into Benjamin said that great concern existed treated differently sufficient common ground to allow the process, some of whom were not in regard to emerging diseases, such as collaboration traditionally used to working in an area monkeypox and pandemic flu, and he 4. Bioterrorism is a mixture of “infectious common concepts and assumptions that had a security focus. He added that confirmed Moodie’s comments that the disease and intent” (“a rallying cry for mutual terminology the environment was “fiscally-constrained”, pubic health community was one that transatlantic co-operation”). shared tools – military, diplomatic and so international cooperation was critical. was “uncomfortable” about working in a economic Priorities had to be set and this required a security mode. 5. Biotechnology advances will have an impact high degree of coordination, understanding – with both good and bad consequences. Such an infrastructure had been useful when and common approaches that had so far Benjamin said the US public health authority the transatlantic partners had disagreed and been lacking. was building-up its infrastructure - defined Reviewing the bigger picture, Franz saw Moodie called on international bodies to as “people, training and tools”. Linking the areas where the community faced serious work together to develop one to meet today’s “we do not have a common intellectual first two items, he described the shortage of challenges, as there is: challenges. He added some suggestions as to infrastructure and it would well behoove us trained scientists and the need for structural how this might be achieved: to develop one” reform ( such as detection methods and in 1. too much faith in “air monitors and public information systems). Benjamin also gadgets” to issue warnings 1. Thought processes must be changed: be- stressed the need to build relationships before cause the misuse of life sciences cannot The principles of public a crisis occurred and described preparedness 2. not enough integration of animal and hu- be eliminated, bioterrorism is a risk that health preparedness as going “from chaos to controlled disorder”. man public health issues – Franz recom- has to be managed. mended a “species neutral” approach
2. All risks to be examined: the deliberate mis- Georges Benjamin, Executive Director 3. too great a focus on vaccines as counter- use of life sciences must be seen as part of a of the American Public Health Association, measures for unknown threats (shelf-life,
broad spectrum that includes re-emerging described the state of US public health 2 monkeypox is a rare illness that causes rash, chills, and fever. It is caused regulatory and liability issues make these by the monkeypox virus, which belongs to the same family of viruses as infectious diseases, laboratory accidents, etc. preparedness, based on four principles: smallpox but is not as deadly. (http://www.sutterhealth.org/). very expensive)
NEW DEFENCE AGENDA 19 4. a lack of attention to non-specific infrastructure, as communications were during the events of 911 and the subsequent business continuity plans in place (to maintain counter-measures and therapies and poor. Mann stressed the need for actions to cope with the new threats. He essential services as part of the Critical exploitation of the genomics revolu- consistent and regular contact between was deeply involved in dealing with the National Infrastructure for society at large). tion is not being sufficiently exploited the related communities (technical “White Power” attacks in the UK that a. the basis of a possible transatlantic staff, the politicians) and supported the followed the Antrax attacks in the US. “Manhattan” project to further examine idea of a matrix. This could contain the Beginning his talk, he looked first at the Setting the scene human immune systems – to improve available tools, scenarios, critical factors, consequences of a “white powder” attack. for debate the resistance of populations priorities, actions to be taken, etc. It also As background, he explained that there had implied that an agreement on common been over 200 events in the UK following NDA Director and co-moderator Giles 5. more reliance on deterrence to balance terminology was critical, together with a the US Anthrax incidents, that required Merritt argued that the political and preparation for response definition of common concepts and tools. serious investigation and engagement of the administrative machines of complex But there were other vital issues - what emergency services. western societies had to be set in gear. To 6. more collaboration – at national and in- were the various roles and responsibilities this end, Merritt had some questions for the ternational levels for nations, neighbouring states and Abbott focused on the effect induced, assembled experts in regard to transatlantic international organisations? the crisis management requirements, the relations: Franz saw no simple solution. It requires consequence management issues raised and 1. Who is working with whom? (the US gov- a balanced approach between technical Turning to Europe, Mann saw differences the remedial measures identified. Above all, ernment, the EU, NATO, the European and non-technical (societal and human between the state of readiness of EU he identified the centre of gravity is for the Commission, member states – were behavioural) solutions, between hard member states (stockpiles of vaccines public to maintain confidence in the national these relationships multilateral, bilateral?) power and soft power (“difficult in the for example), so priorities had to be set government. This implied: US’s two-party political system”) and in in advance. Different scenarios had to 2. What does working together mean in prac- international relationships. be considered (would some borders be Finding effective national and international tice? (is it sharing ideas, intelligence, stock- closed? what part of the infrastructure was public information policies: that strikes piles of vaccines, expertise – all of these?) Quoting Edward R. Murrow, who critical?). Overall, her message was that a balance between proactive (without said, “It’s the last three feet between the process had to be fully inclusive – to scaring the public) and reactive measures 3. In which areas are transatlantic links not people that make the difference”, Franz involve the US, the EU and its neighbouring working effectively? concluded that the human aspect of countries, and further afield. Engaging the private sector: critical communications was vital. services have moved to the private 4. How can the need to communicate with sector and the need to be competitive the general public be made a central issue? Wanted: Public has introduced “Just in Time” rather than Merritt was concerned that some 200 A need for intellectual information policies “Just in Case” methodologies (i.e. no white powder attacks in the UK had infrastructure reserve stocks in the supply chains). gone largely unreported; how open Brigadier Ian Abbott, Chief of Policy should public announcements be? Erika Mann, MEP and European and Plans Division at the European In conclusion, Brigadier Abbott wanted representative to Atlantic Storm, described Union Military Staff, served as Director governments, and relevant parties from 5. How could legal powers and frameworks “Atlantic Storm” as an extraordinary of Capabilities in the UK Cabinet Office the public and private sectors, to develop, be introduced consistently across member exercise. She agreed with Moodie that responsible for contingency and continuity understand and practice crisis management states? there was a need to develop an intellectual planning and consequence management procedures and to have effective and resilient
NEW DEFENCE AGENDA 21 Resources, budgets & checks might place barriers in the way of US – prepare for the full spectrum of biological with their limited resources, to protect security clearance EU collaboration and Moodie opined that the risks by arguing that the problem was civilians without the full collaboration of US reaction could be seen as “over the top”. even broader. A crisis might start with a the civilian “blue light” services. Abbott The Western European Union’s Paolo terrorist attack, but it could soon expand added that governments were accountable Brito saw many similarities between the to include flooding, loss of power and to their citizens and “openness and US and Europe in terms of public health Agro-terrorism, accidents other complications across a wide area. He education” were important tools which approaches, except that the European and infectious diseases argued that the “Atlantic Storm” exercise should be used to inform and shape people Commission had no federal powers. He was too complex and that it would be expectations in order to be prepared. saw problems with declining public health Brito was concerned about “agricultural more effective to develop a number of budgets and a shortage of trained scientists, warfare” at a time of reduced control at US small scenarios. Once these had been with the need for security clearance ports and a possible expansion of the EU successfully concluded, exercises on a Collaboration – the key exacerbating the situation. In response to to include “grey zones” such as Moldova, larger scale could be envisaged. Brito, the Commission’s Jan Peter Paul Ukraine, etc. Paul added his fears about: the Frank Rapoport, a Partner at McKenna said that research funds would be doubled uncontrolled spread in Africa (impacting Benjamin was equally practical. Any Long & Aldridge, agreed with Mann that for the 7th Framework Programme. several countries) of the Marburg virus, infrastructure that was required had to collaboration between neighbouring and the accidental distribution of the H2N2 be built on existing foundations, as people countries was vital. He explained that the US Georges Benjamin commented that virus by the Centers for Disease Control did best what they did every day. He was working closely with Canada, a country a great number of the US’ public health and Prevention (CDC). On the subject suggested that “everyday events” be used with a vibrant biotech industry, as it had new laboratory facilities were in a state of of agro-terrorism, Franz regarded this as to test facilities, as developing large-scale solutions for anthrax, smallpox and tularemia. disrepair. Painting a gloomy picture, he stated an attack on the economy. His worse fear fictitious scenarios brought no benefit. The BioWeapons Prevention Project’s Jean that between 25% and 50% of public health was an outbreak of Foot & Mouth disease Benjamin also suggested the people who Pascal Zanders saw collaboration being staff would retire in the next five years. There (FMD) that could lead to economic costs would be involved in the genuine alerts difficult in Europe, due to nationalistic views was therefore an urgent need to hire skilled of tens of billions of dollars in the US. Franz (police, security, public health authorities) being paramount in an EU context. workers familiar with new technologies, a knew that consequence management should be the ones running the scenarios, problem worsened by the fact that public planning was ongoing at the state level but rather than senior politicians. Tigner wanted more definition of terms health authorities had to compete with the he saw a need for more consolidated US such as intellectual infrastructure and matrix (highly paid) private sector. national efforts. as the international community was already The role of the military acutely aware of bioterrorist threats (with David Franz said it was hard to staff their monitoring information centres and new laboratories. This problem was being Scenarios & simulations In the context of the development of a laboratory standards). heightened by the need for background common infrastructure, Defense News’ security checks for staff working on “select The Stockholm International Peace Brooks Tigner wanted to know how In response to Merritt’s and Tigner’s agents”. Note (1): It was later confirmed that Research Institute (SIPRI)’s Richard military authorities planned to share questions, Erika Mann was certain that full security clearance was only required for Guthrie responded to Moodie’s call to information with the civilian community. transatlantic co-operation was insufficient. It employees working at the US Department of That was not a decision for the military was fragmented and incoherent. Expanding Defense (DOD) and the US Department of The virus appears to be native to central Africa and the first reported said Brigadier Abbott, but rather one for on her ideas for the development of an cases were from scientists exposed to infected monkeys. Homeland Security (DHS). Note (2): Franz The CDC has since said it was not responsible for the distribution of the the government of each individual member H2N2 virus (see http://www.cdc.gov/flu/h2n2backgroundqa.htm). During Tularemia, or rabbit fever, is a bacterial disease associated with both ani- later added that the need for such security the debate, Benjamin made the same comment. state. It was also impossible for the military, mals and humans.
NEW DEFENCE AGENDA 23 intellectual infrastructure, Mann said that this The Polish Embassy’s Stanislaw Janczak Merritt noted that while the US had a would be a fundamentally different concept had been present at Atlantic Storm. In his durable, tried and tested political system, Intellectual Infrastructure that would not aim to give clear and precise opinion, the US and the EU had not yet this was not the case in Europe. He answers to the problems of bioterrorism, but started to communicate. Messages were agreed with Abbott that there was a real Composition Consisting of experts, scientists, politicians, would lead to much improved collaboration not passed between European and US problem of accountability, with Brussels the cyber community, etc. – and ultimately to results. She added that authorities. There had to be communication being a town where argument between the aforementioned matrix would be a methods set-up now, to be used in the case subsidiarity and centralisation were faced Objectives snapshot of today’s situation that showed where biological agents were released. every day. However, the threat was current To develop a shared view of the problems faced To develop shared terminology and tools the state of readiness (geographically, tools, – and Merritt wanted to know who was (military, diplomatic and economic) preparedness, contacts, etc.) and weak Brigadier Abbott thought that many of in charge when it came to countering areas (in the EU and in the US). the day’s questions were symptomatic of bioterrorism. That was the problem to Scope a general problem, in that there was no be addressed – sooner rather than later. Global (not limited to the US and the EU) Both the intellectual infrastructure and matrix effective public information system in place would require ongoing communication and that achieved a balance between preparing collaboration, as it was essential to build rather than scaring the various populations. The EU’s view The development of a common on the developed expertise. Only in this He also agreed that it was necessary to build threat assessment (initially between way could the authorities show citizens on existing practices and identify who was Annalisa Giannella, Personal the EU and the US) that they were in control and that political ultimately accountable. In addition, Abbott Representative of the High Representative management was in place. did not want scenarios to be invented, there for matters of non-proliferation, Council Greater compliance; the US and the EU were enough genuine accidental cases that of the EU said she was responsible for the could assist third countries in drafting Michael Moodie thought that the very could be used – and whether by accident or prevention of WMD proliferation and had an legislation in order for them to comply need for the meeting showed that the design, the results were the same. We need “understanding” with the Counterterrorism with the Biological and Toxin Weapons US and EU were not working together to consider the effects and then be able to Co-ordinator Gijs de Vries, especially in the Convention (BTWC); sufficiently. Some actions were underway conduct crisis response and consequence area of bioterrorism. To answer Merritt’s as no model legislation exists, the but many actors on the US side were management procedures simultaneously. question, she had faith in the approval of US and EU could try to establish frustrated as they did not know whom the new Constitution (together with the some “models” and then work in to contact in Europe. He also reasoned CBACI’s Michael J. Powers responded to creation of a joint external action service synergy in their bilateral assistance that NATO had been sitting on its Merritt’s comment re the US’s fragmented – bringing together the Council Secretariat programmes to third countries. hands in regard to bioterrorism. On the approach. He argued that the DHS saw and European Commission services positive side, Moodie saw that the G8 had money as the answer – it was working together with diplomats seconded from Improved verification and control: committed itself to a bioterrorism work towards creating a single integrated system national diplomatic services), which would members should regularly submit plan, the Health Security Action Group for managing emergencies. However, this facilitate the co-ordination of counter- “Confidence Building Measures” (CBMs) (G7 plus Mexico) had plans underway and was a contentious issue at state and local bioterrorist activities. but responsibilities are unclear the WHO and InterPol were launching levels. Powers also commented on the Giannella suggested the creation of initiatives. But he repeated that the logistics problems involved in distributing In terms of US and EU collaboration, a “small unit” under the BTWC, that traditional transatlantic partnership did vaccines once such a need had been Giannella recommended closer ties on com- could examine CBMs and be a con- not exist; there had been a lot of talk but identified. This was also a responsibility of pliance and verification in the biological area tact point for non-aligned countries not much action. the public health authorities. in the following areas:
NEW DEFENCE AGENDA 25 Giannella also bemoaned the discussions in regard to how UNMOVIC’s and in Europe. He felt that the EU looked simply said that the approach inherent in lack of a verification protocol; she expertise could be retained. She welcomed at bioterrorism as a public health issue the BWC protocol was not workable. They wanted a code of conduct for Moodie’s comments regarding the Advisory whereas the US saw it as a matter of preferred a “working group, expert group, laboratories and ways of raising Scientific Body and added that she would national security. He wondered how this work programme” approach. The Review awareness between scientists take that idea forward. influenced the thinking on both sides of the Conference was important, and ideas were Atlantic. coming forward but the underlying scientific another element was the need to Merritt agreed with Giannella that industry environment was changing fast. retain the expertise of The United had a role to play and that it had to be On threat perception, Giannella said the EU Nations Monitoring, Verification and involved in the policy-making process in had to update its thinking and then “compare Paul commented that China would be Inspection Commission (UNMOVIC), the face of bioterrorism threats. However, notes with our American friends”. While training one million scientists per year. He as the UN needs expertise to be he was not sure how it could be achieved. agreeing with Zanders, she felt that the US thought that companies would continue available on request Giannella thought that it would be natural as well had initially regarded bioterrorism to move their laboratories to China and (with the Review Conference approaching) as a health issue. The important thing was India and that these two countries had Giannella also noted that the idea of an for national authorities to contact industry to create a threat assessment and keep it to be involved in any future agreements Advisory Scientific Board had recently to see what it could do in terms of improving regularly updated. and discussions. Giannella thought the EU been launched. This could follow the latest compliance and control. could do that, as the security dimension developments in bioterrorism and alert the Zanders was also concerned that Moodie (non-proliferation) was being developed in decision-makers. Giannella recommended Michael J. Powers commented on the had implied that a body that reviewed negotiations with third countries. The EU that the US get involved, together with need for model legislation to help third ongoing scientific developments would was constantly changing its methods of co- industry, under the BTWC framework. parties and thought there could be much be sufficient. Moodie said he had been operation and was including security issues debate and discussion on the content (simple misunderstood. The US administration had in all trade negotiations. compliance with the BTWC obligations or Q&As for pathogen control and bio-security). He was Annalisa Giannella not sure however if a single model could be applied to all countries. On this issue, Moodie intervened to say he did not think Giannella thought that several models might that the US would welcome the retention well be needed. However, she was starting of UNMOVIC expertise as it might be seen from scratch, as it was not clear about the as a “back door to verification”. It could existing legislation in the EU member states. be rejected for the same reasons that the A joint action with the Organisation for the protocol negotiations had failed. But Moodie Prohibition of Chemical Weapons (OPCW) saw a future for a body that reviewed was taking place to draft legislation. But for ongoing scientific developments and the biological weapons, nothing existed. An possible implications of the misuse of biology. OPBW was needed – and why couldn’t He thought that could fly in Washington. preparatory work take place with the US?
Giannella agreed it was a sensitive area Jean Pascal Zanders commented on and added that the EU might well seek different threat perceptions in the US
NEW DEFENCE AGENDA 27 Session II bioterrorism. Referring to the resulting and Murch did not want to wait for a crisis. complex “dual-use research”, he reasoned He wanted a systems approach to crisis What future for bio-defence industry and technologies? that it had scientific, technological, ethical, response management and he felt the NDA moral, legal, political and policy implications. could provide structure in this area. Murch Despite the difficulties, he saw this as both also wanted a state of “full readiness” and a Project BioShield buy drugs or counter-measures, not only a challenge and an opportunity for the US set of coherent standards was required - to to pathogens but also to counter infectious and Europe to work together. which agencies on both sides of the Atlantic Providing some background to “Project diseases (such as avian flu or pandemic flu). It could aspire. BioShield”, co-moderator Frank also includes funding for the construction of the Murch identified several joint areas for Rapoport of McKenna, Long & Aldridge necessary biosafety level 4 (BSL4s) facilities. collaboration, where he wanted a more described the US government’s necessity to systematic approach to developing, A call for regional engage the pharmaceutical industry in the executing and measuring initiatives. This stockpiling fight against bioterrorism (against anthrax, The power of scientific process would include: smallpox, tuleremia, etc.). This had been knowledge Florin Paul, Deputy Surgeon General greatly facilitated by the SARS outbreak. As the definition of problems of mutual concern in Romania’s Ministry of Defence, was also a result, Rapoport forecast that there would Randall Murch, the Associate Director the analysis of questions and problems at pains to stress that he was including the be an enormous “pharmaceutical biodefence for Research Program Development at (from US and European perspectives) spread of infectious diseases in his definition public health infrastructure” within five years. Virginia Tech, and former Director of the identification of priorities and gaps of bioterrorism. As he was concerned about Advanced Systems and Concepts Office at the design of solutions the capability of any single organisation to The “BioShield” initiative streamlined the Defence Threat Reduction Agency, with be responsible in the event of a biocrisis, the FDA approval process so that the nearly 23 years of service in the FBI, saw Overall he wanted to move from “thought Paul wanted regional authorities to be able government could purchase drugs before opportunities for US – European scientific to action” by developing executable plans, to take decisions. On the subject of industry they had FDA approval. In essence, it co-operation not only to fight bioterrorism, and he suggested that the NDA might be a involvement, he had been impressed by was a way of getting the pharmaceutical but also to combat current and emerging good starting point for such discussions. He Rapoport’s explanation of how the US industry on the government’s side – a new infectious diseases in the human, animal, therefore recommended the implementation government had gained the pharmaceutical development according to Rapoport, and plant and food supply chains. Stressing of flexible, robust and adaptable systems industry’s support. Within Europe, there one that he recommended that Europe the need to understand how nature was – both human and technological – on a was a similar issue, as he was concerned should consider. evolving, he looked to technologies that transatlantic basis, in order to achieve full about the production of “orphan drugs”. would help the protection, clean-up and collaboration across four key communities: Someone – in Europe - had to take the risk Rapoport explained that therapeutics (cures) re-population of the environment. public health, agriculture, law enforcement & and provide necessary funding. were seen as the correct approach, rather public safety and intelligence. than vaccines, as people were unhappy about Murch argued that scientific knowledge Addressing the issue of bioterrorism in the latter course of action. Moving to the was racing ahead at an enormous and It was necessary to show these four practical terms, he saw local authorities having larger “BioShield 2” legislation, Rapoport unprecedented pace, bringing opportunities communities that they are interdependent a role to play at the tactical level. However, said it expanded the government’s ability to to combat disease and help in the fight against and then move on to full interoperability. when it came to strategic discussions, he
Definition from the FDA website: The term “orphan drug” refers to a On July 21, 2004, President Bush signed into law Project BioShield, which product that treats a rare disease affecting fewer than 200,000 Americans. provides new tools to improve medical countermeasures protecting A biosafety level 4 (BSL4) lab allows researchers to safely handle small It was assumed in this case (and later in the debate) that dual use meant The Orphan Drug Act was signed into law on January 4, 1983. Since the Americans against a chemical, biological, radiological or nuclear (CBRN) samples of infectious disease microbes for vaccine development or for research that was both a) security & defence related and b) for commer- Orphan Drug Act passed, over 100 orphan drugs and biological products attack. (from http://www2.niaid.nih.gov/). diagnosis of patients suspected of being infected. cial purposes, in the realm of public health. have been brought to market.
NEW DEFENCE AGENDA 29 wanted the “requirements in the field” to motivated society to invest in biodefense and combating smallpox and anthrax because develop products to combat malaria and TB. be fully defined before important decisions shaped the nature of the resulting program. those two agents pose exceptionally serious The perception was that the US did not care were taken. For example, on the subject of He regarded the issue as fundamental threats, but the list of additional agents that about the threat from emerging diseases. stockpiling, Paul saw many issues to be tackled and said it was clear that there was no might be used in an attack was endless and if it was decided to create regional stockpiles. consensus on the issue of threat perception. even the US could not afford to develop Answering Smolinski’s question, Gerald It would be necessary to agree on: expensive countermeasures against very Epstein looked to future legislation that It was therefore difficult to define either many of them. Epstein concluded that both would augment the Bioshield program, the location of the host country and the necessary resources or the structure of the US and Europe faced a major challenge and that would allow therapeutic agents the responsible body for coordination the programme to be developed. Epstein – the need for a “flexible responsive and vaccines to be developed that would customs clearance and transportation highlighted the problem, linked to the issues adaptive programme”. combat the spread of infectious diseases in issues (to avoid delays) of threat perception, the gap between proven addition to those to be developed to counter treatment of the stockpiled and clearly foreseeable technical capabilities bioterrorist attacks. Thus funds from federal products (each nation’s medical and (in the realm of bioterrorism) and the limited Communications projects would be available to fight diseases pharmaceutical regulations) scale of attacks actually undertaken. With like malaria and TB in the developing world. the delivery of the products in an the business world’s increasing interest The Israeli Centre for Disease Control’s However providing government funding emergency in biotechnology, and the widespread Manfred Green wanted to improve to benefit drug development efforts in financial matters (costs, reimbursement) international diffusion of the technology, he communication about the issue. This would the pharmaceutical industry would not be the security and safety of the stockpile reasoned that it would be more difficult to reduce the impact of bioterrorism and popular with many in the Congress. Epstein cultural, linguistic, religious, legal and develop accurate intelligence: the signal being there would be many interested parties, saw the need for careful legislation that did not other matters sought (i.e., evidence of a malicious program) including the vaccine manufacturers. arbitrarily distinguish between public health is very hard to detect, and the background He recommended that a joint (US and and biodefense, as the ability to differentiate This was only one example, but Paul noise in which it would be hidden (i.e., European) programme be created to between public health and bioterrorist felt it was one where US – European legitimate commercial and scientific activity) conduct research on the development of threats would get harder in the future. collaboration could be useful. He preferred is exponentially increasing. “common risk communication techniques”. Richard Guthrie introduced a “highly- that Europe took a regional approach when charged political issue” by asking what facing the issue of bioterrorism as Europe Epstein also argued that even if he had The NTI’s Acting Vice President for Biological constituted a public health emergency. In is not structured as the US with a single perfect knowledge of today’s situation, Programs, Mark Smolinski, picked up the past, former Health and Human Services federal administration. (i.e. the identity, location and intentions the issue of risk communication. He had Secretary Tommy G. Thompson had been of those who had the capabilities of a responsibility to communicate the US’s ready to sign a patent waiver following committing bioterrorist attacks), it would decisions to people in developing countries. (just) five deaths in the US. Guthrie wanted Difficulties be impossible to predict the future threat, Smolinski found it difficult to explain the common standards (for the definition of as the technology was advancing so rapidly emergence of the BioShield programme (that a public health crisis) to be agreed on a Gerald Epstein, Senior Fellow for Science and the time necessary to develop a hostile was funding the pharmaceutical industry to global basis. On a related issue, he asked for and Security in the Homeland Security program is less than that required to fight Class A and Class B agents10) whereas common health standards on illnesses and Program at the Center for Strategic and develop countermeasures. He regarded this there had been many demands for the US diseases to be defined (so that, for example International Studies (CSIS), took up Giannella’s mismatch as making it impossible to base a to assist the pharmaceutical companies to in the developing world, the need for basic point concerning threat perceptions, as biodefence program on specific intelligence hospital care could be set against the need to 10 Class A agents include anthrax, smallpox, plague and tuleremia; Class B it was the nature of the threat that both information. Money is well spent on agents include the more common food-born agents Salmonella and E. coli. monitor outbreaks of infectious diseases).
NEW DEFENCE AGENDA 31 Laboratory procedures currently being conducted in the US under and he saw two key requirements: an early the audience. Moodie felt that there was the leadership of the DHS. detection system (very expensive if this was much work to be done in order to achieve The German Collection of Micro-organisms in real-time) and a surveillance system. concrete results. (DSMZ’s) Christine Rohde wanted more With reference to Epstein’s comments on efficient “registration, documentation and information gathering, Randall Murch Stanislaw Janczak wanted a co- Giles Merritt was more positive, reporting” of laboratory practices within suggested that the intelligence communities operative approach to be developed in the expressing himself happy with the results the BTWC. She called for such practices had to adapt their methods. They should case of mass casualties. Assuming a worst of the day’s debate as it was sending the to be placed under the control of the utilise more open source11 and human case scenario, that meant the spread of attendees away with more questions than WHO and the UN. Rohde argued that intelligence, the latter being “the best way contagious disease. In that case hospitals they had brought to the table. Looking to the biodefence industry and biodefence to collect information.” would be closed down. Janczak therefore the future, he said he would welcome NDA research, which she regarded as “health argued for priority to be given to first involvement in a European follow-up to the protection research”, should be under the Epstein stressed that intelligence was responders, i.e. medical staff attending the Atlantic Storm exercise. However, it should WHO’s “neutral” control. important but one had to understand its victims so that quarantine and isolation look at a totally new set of questions, from limits. Agreeing with Murch that different procedures could be conducted effectively. a primarily European perspective. George Benjamin had grave doubts methods are required, he pointed out that about the WHO’s capability to act as the one problem is that the scientific community After listening to the day’s debate, Merritt world’s public health authority. As its funds and the intelligence community need to A security matter or concluded that Europe was one of the were severely limited, the WHO would work together in ways that are unfamiliar, public health? problems. For example, it had no idea of need a massive injection of resources and and likely uncomfortable, to both of them. the financial resources required to combat an improved infrastructure in order to play On the subject of whether bioterrorism was bioterrorism. In his opinion, EU policy-making a meaningful role in the process. The Landau Network’s Maurizio a matter for the security services or the public on counter-terrorism could not be left to the Martellini wanted improved information health authorities, Epstein argued frankly Europeans. Likewise, US policy-making could The European Commission’s Barbara sharing, perhaps funded by a public-private that the US would never have approved the not be left to the Americans. It was a joint Rhode called for stricter controls on partnership, which could lead to a databank funding for BioShield if it had been seen as problem that had to be tackled together. clinical trials conducted in the developing of knowledge (of infectious diseases) and even a public health issue (and hence essentially world, as these were becoming more to University-based educational courses. commercial in nature). In his opinion, the Merritt was keen to repeat the day’s fashionable. She was especially concerned US government had major problems with exercise, perhaps with a thorough about the effect on the local population, as commercial organisations requesting funds examination of bioterrorism and counter- in some cases it was their only method of Being practical for (federal) purposes, whereas in Europe, terrorism. It was vital to continue to solicit receiving hospital treatment. defence and security projects often had American views and experience, as the US Florin Paul wanted to keep things practical government connotations. would always be ahead of Europe due to its and reasoned that you had to prepare for single-government structure. Threat assessments / problems that actually existed, such as the Wrapping up, Michael Moodie said that intelligence gathering threat of malaria or TB. The results of such although it was important to communicate, outbreaks would be similar to a bio-crisis one first had to be sure about the message While stressing their importance, Frank to be conveyed. He was not yet convinced
Rapoport disagreed with Epstein’s views 11 “Open Source” intelligence, such as that in newspapers, Internet sites, that the message was understood, nor who books, magazines, and foreign radio broadcasts. (http://www.globalsecu- on threat assessments, as they were rity.org/) should provide it or the actual identity of
NEW DEFENCE AGENDA 33 Agilent Technologies
2850 Centerville Road Wilmington, DE 19808 Tel: 800-227-9770 Fax: 302-633-8953 Web: www.agilent.com
PCR Based BWA Detection & Confirmation System
Agilent Technologies Inc. and Invitrogen Corp have cooperated in the development of the PathAlert™ Detection System, a complete screening and confirmatory detection system for infectious agents such as anthrax and smallpox. The PathAlert System features Invitrogen’s new PathAlert™ Detection Kit and the Agilent 2100 bioanalyzer.
Agilent 2100 Bioanalyzer The Agilent 2100 BioAnalyzer uses microfluidic lab-on-a-chip technology to provide rapid (< 3 min/sample) qualitative and quantitative information on DNA, RNA, and proteins in biological samples. Biological pathogens can be detected and identified using the 2100 bioanalyzer after specific DNA sequences from the chosen pathogens are amplified by polymerase chain reaction (PCR) using selective primers. Analysis: The primary advantage of the 2100 bioanalyzer relative to other 12 PCR based detection methods, such as real time PCR, is that the “The EU is not a United States of Europe.” 2100 bioanalyzer allows for multiplex detection assays that can simultaneously interrogate collected samples for many different types of bacteria and viruses. A multiplex assay enables a Jill Dekker-Bellamy laboratory to routinely test for up to 16 PCR products in a single analysis vs. up to 4 products using Real Time PCR. This results Bio-Defence Consultant, New Defence Agenda in dramatically reduced operating costs as well as a more efficient workflow F12 Invitrogen PathAlert Kit Within a wider international framework, becomes static and fails to address common PathAlert, a kit for detection of B. anthracis, Y. pestis, F. tularensis, and Orthopox, meets the the transatlantic relationship is a key security interests. This session examined challenging requirements for sensitivity, specificity, throughput, and cost. Based on PCR technology and proprietary novel modifications to reagents and primers, the kit includes a universal internal asset in preparing to meet the challenge not only differences in capability, interests positive control for self diagnosis, selected dual target loci for sample detection, and corresponding engineered external positive controls for pathogen specific false positive readings when using the posed by the threat of unconventional and objectives to counter bio-terrorism but PathAlert system. Using the PathAlert multiplex-PCR kits with the Agilent 2100 bioanalyzer, the weapons use and mass casualty terrorism. our ability to overcome real and possibly system can monitor multiple DNA targets and a series of internal controls in the same analysis without the multiplexing constraints imposed by conventional real-time PCR. Differences in perception can play a long-term differences to achieve mutual significant role in whether or not the public health security goals. Europe has transatlantic relationship moves forward experienced terrorism for decades but and the partnership is strengthened or if it until the Madrid mass transit bombings in March of 2004 the type of terrorism was 12 stevenson, Johnathan, “How Europe and America Defend Themselves,” Foreign Affairs. Council on Foreign Relations, March/April 2003. URL: largely limited to known national groups http://www.foreignaffairs.org/20030301faessay10340-p20/jonathan-ste- venson/how-europe-and-america-defend-themselves.html utilizing conventional terrorist weapons.
NEW DEFENCE AGENDA 35 The use of biological agents even by a structured on a more national basis so the and transnational threats. Interpol has with determining if bio-terrorism is a national group has the potential to cross concepts usefulness for Europe may not launched a bio-terrorism section. With threat and how best to strengthen the borders making unconventional weapons prove highly applicable in a wider transatlantic its well established institutions Europe transatlantic partnership to counter it use not only a European wide problem dialogue. Moreover initiatives taken at the is perhaps in a unique position to confer were somewhat obscured. Undoubtedly but an international one. The prospect of European level often go by unnoticed by the best practices to the United States both in intelligence capabilities are essential to first Al Qaeda targeting European territory US, who, with a unilateral approach, tries to terms of multi-lateral engagement, human determining threats then appropriately will make the need for vigorous European impart best practices to nations with vast intelligence18 capability needed to track responding to WMD and the threat of territorial defence acute, this in turn will experience with terrorism and well versed in terrorist recruitment and activity in Europe unconventional weapons use by terrorists. stimulate a natural convergence of European countering transnational threats. and internationally, investigative jurisdiction Significant US intelligence failures in a and American agendas.13 Given the recent and preventative diplomacy which can number of key areas give cause for concern enlargement of the European Union State sponsors of terrorism and terrorist serve to strengthen defences against 21st within the European Communities. security challenges such as Chechnya and networks such as Al Qaeda represent century security threats. Recently a number instability in the Transcaucus may become transnational threats very different to of Member States have coordinated their The European approach, far from creating a intensified security issues over the next the type of threat posed by traditional intelligence which resulted in the capture of homeland security sector, generally maintains decade. Network terrorism and the use of European terrorist groups such as the IRA several individuals trying to refine Ricin into even distribution of human resources and unconventional weapons in this context is or even Hamas. With potentially thousands some kind of weapon and the capture and builds upon science and technology.20 clearly a critical transatlantic issue. of members and no interest in bargaining detention of Islamic terror suspects in the with the United States or its allies Al Qaeda Madrid transit bombings. Title VI instruments capture a much wider Gaps in capability and resources on both seeks to inflict mass casualties possibly field of security concerns than merely sides of the Atlantic have served to shape with weapons of mass destruction.15 It is “September 11 demonstrated that terrorism; it covers both police and judicial threat perceptions. How can the United impossible to imagine Osama bin Laden’s America’s security is organically linked cooperation in criminal matters an inter- States and the European Union better followers apologizing for inadvertently killing to Europe’s vulnerability to infiltration by governmental arena of cooperation understand not only differences in approach Americans…as Hamas did, after a suicide terrorists.”19 within the EU in which the European but an appreciation for unique capabilities attack on Jerusalem’s Hebrew University in Commission shares the right of initiative each side brings to the table? The concept August of 2002.16 Are we addressing with EU Member States.21Last year, the EU of ‘homeland security’14 and establishment announced it would step up cooperation of institution(s) specifically consolidated after Although acts of Arab national terrorism the right issues in the between the intelligence agencies of its 25 9/11 is an accepted US approach, it is not on US soil is a relatively new experience transatlantic context? member states. The move is part of the however a common European level position in the United States, France, has recently EU’s response to the terrorist attacks in where subsidiary must be consistently be shown greater concern about mass casualty While the focus of the April 25th session Madrid and recognition of the potential for factored in to action. Homeland Security attacks and unconventional weapons use.17 was squarely set on “Homeland Security” unconventional weapons use. “The threats covers such a converse area of protection Moreover both Europol and Interpol have and to a lesser degree proposing crisis we are facing today are not national threats across a field of designated US threats seen budgets added for bio-terrorism management strategies, arms control and -- terrorism -- they are international threats. where European initiatives are defined and counter-proliferation methods, problems
15 Stevenson, Johnathan, “How Europe and America Defend Them- 20 Solana, Javier, “EU Takes First Step toward Joint Intelligence Ca- selves,” Foreign Affairs. Council on Foreign Relations, March/April 13 Ibid., Stevenson, 2003. 18 Ibid. pability”, EU Business, 9, June 2004. URL: http://www.eubusiness. 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- com/topics/European_Council/EUNews.2004-06-09.3325 14 Homeland security consists of all military activities aimed at prepar- p20/jonathan-stevenson/how-europe-and-america-defend-them- 19 Stevenson, Johnathan, “How Europe and America Defend Them- ing for, protecting against or managing the consequences of at- selves.html selves,” Foreign Affairs. Council on Foreign Relations, March/April 21 Den Boer, Monica, “9/11 and the Europeanisation of Anti-Terror- tacks. [ ] It includes all actions to safeguard the populace and its 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- ism Policy: A Critical Assessement”, Groupement D’Etudes et de 16 Ibid., Stevenson, 2003. property, critical infrastructure, the government and the military, its p20/jonathan-stevenson/how-europe-and-america-defend-them- Recherches Notre Europe, Jacques Delors, Policy Papers No. 6, installations and deploying forces. RAND 17 Ibid.,Stevenson, 2003. selves.html September 2003.
NEW DEFENCE AGENDA 37 Therefore, to put together the intelligence Understanding Differences: with on an emergent basis, after particular prevention and preparedness? NATO which is international with intelligence which Threat Base or Compre- threats have arisen.24 structures might, in theory, help fill the gap is national will be a very important step by coordinating efforts at counterterrorism forward in the coordination of the European hensive planning Should we discuss bio-terrorism in the and homeland security; indeed, the alliance Union [counterterrorist measures].”22 To transatlantic context at all when Member has already established five concrete what extent is threat perception and our Europe’s perception of the threat posed by States and the United States must get counterterrorism instruments: a mobile lab capability to determine next generation terrorism, even after September 11, 2001 their own houses in order first and the for analyzing nuclear, biological, and chemical unconventional weapons use accurately; has remained intrinsically different from international community as a whole (NBC) weapons; a prototype NBC response dependant on a wider array of capabilities? America’s -- perhaps justifiably so; both must be fully engaged? Unfortunately team; a virtual “center of excellence” for Has US superiority and reliance on science Europeans and Americans understand the intersecting of bioterrorism and our NBC weapons defense (consisting of a and technology obstructed not only threat that the war in Afghanistan and new law- understanding of transnational threats is standing, Brussels-based system of intranet perception but response? Where technical enforcement and intelligence cooperation too great a problem and too diverse in links among national study centers and capability gaps exist between the EU and have not stopped al Qaeda.23 Engagements scope to wait until everyone is ready. An their experts); a biological and chemical US who make for an unbalance relationship, in Afghanistan and Kosovo have arguably open border Europe where the free flow of weapons defense stockpile; and a disease analytic capability and resource management reshaped terrorism and added impetus to commerce, people and animals coupled with surveillance system.25 Perhaps it is within by specific US intelligence agencies factors movements previously considered non- transnational criminal syndicates working the transatlantic context that NATO into how Europe perceives the transatlantic aligned. The recognition of the use of WMD across our Community in direct contact should play a more visible role in helping relationship and can essentially build trust to or biological weapons by terrorists and with terror organizations means tighter to coordinate preparedness and response counter bio-terrorism and the threat of WMD. state sponsors and US policy orientation to security legislation must be enacted. While planning as the Member States who prevent it did not simply emerge out of 9/11. it would be ideal to approach bio-terrorism comprise it already collaborate at a well “A profound lack of American interagency These policies were well underway during preparedness on a state by state basis integrated and consolidated level within coordination, [ ] prompted soul-searching the Clinton administration. where each nation builds its own resources the transatlantic framework. NATO’s in existing US law-enforcement and and capabilities, a mass casualty event with formidable capabilities could be an asset intelligence services and the creation of The September 11th attacks were planned a biological agent likely to cross borders in assisting NATO Member States and the Department of Homeland Security. nearly two years prior to the event. We and cause panic means this is no longer a coordinating with the United States in France’s highly effective intelligence cannot discount the possibility of another practical option. The nature of biological delegating resources. coordination system -- centered in the mass casualty attack possibly with biological weapons necessitates engagement in both Secretariat Generale de la Defense agents in the future. Where U.S. homeland dialogue and actual preparedness planning in The World Health Organization would Nationale and spanning the executive security strategy is now driven by potential the transatlantic community simultaneously be a likely institution for emergency and judicial branches -- was itself the consequences, European security tends in order to meet the challenges we will face public health planning and provide non- product of administrative disarray in to pivot on probabilities; most European at the international level. stockpiled vaccines and therapeutics in the French counterterrorism in the 1980s and governments, accordingly, have continued event of a global pandemic. [To prepare therefore merits close American study.” to approach terrorism as predominantly Although the meeting did not address for bioterrorist attack, many nations have Johnathan Stevenson a problem that can be assessed and dealt NATO, could NATO provide the conduit integrated bioterrorism response strategies for closer dialogue on biological weapons into their public health care systems.]
23 Stevenson, Johnathan, “How Europe and America Defend Them- 24 Stevenson, Johnathan, “How Europe and America Defend 25 Stevenson, Johnathan, “How Europe and America Defend Them- selves”, Foreign Affairs. Council on Foreign Relations, March/April Themselves,”,Foreign Affairs. Council on Foreign Rela- selves,” Foreign Affairs. Council on Foreign Relations, March/April 22 Solana, Javier, “EU Takes First Step toward Joint Intelligence Ca- 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- tions, March/April 2003. URL: http://www.foreignaffairs.org/ 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- pability”, EU Business, 9, June 2004. URL: http://www.eubusiness. p20/jonathan-stevenson/how-europe-and-america-defend-them- 20030301faessay10340-p20/jonathan-stevenson/how-europe- p20/jonathan-stevenson/how-europe-and-america-defend-them- com/topics/European_Council/EUNews.2004-06-09.3325 selves.html and-america-defend-themselves.html selves.html
NEW DEFENCE AGENDA 39 Nations and international organisations the UK, France and Germany, to adopt the at the minimum, increase defence spending pathogen such as smallpox? This is a limited with the best capability will likely be called Proliferation Security Initiative (PSI) which on CBRN counter terrorism preparedness. example of the impact naturally occurring upon to mount a response, to lead during an aims to prevent the transport and delivery With little to replace it however, what zoonoses and the consequences lack of international crisis. Forming a coalition now of weapons of mass destruction.27 The PSI’s should nations do to test vulnerabilities and emergency disease crisis planning can have offers the best chance of appropriate and objectives and working methods have been ramp up capabilities? EU Member States and during a real-time outbreak. consolidated preparedness and response in set forth in a simple one-and-one-half– the international community experience the event of a major bio-terrorist event. page political statement, the “Statement cyclical outbreaks of Avian Influenza and If indeed this had been smallpox one would of Interdiction Principles,” issued by 11 Classic Swine Fever among other major have to consider what the possibilities might states on September 4, 2003, in Paris. In zoonotic disease outbreaks in close herd be regarding statutory jurisdiction covering From Non-Proliferation so doing, these 11 founding participants— density nations such as those found across a range of policy and regulatory areas not to Counter Proliferation: Australia, France, Germany, Italy, Japan, the European Union. Might this not present to speak of the lack of practical emergency the Netherlands, Poland, Portugal, Spain, smaller scale opportunities to define gaps disease containment and response planning. developing a transatlantic the United Kingdom, and the United in planning and regulation and prepare for The Bio-Terrorism Reporting Group has risk management strategy States—vowed to step up their efforts to a range of bio-terrorism events which have been convened specifically to discuss policy interdict WMD-related shipments in the the potential to impact public health security planning for Category A pathogen threats Making progress in the area of non- transport phase, whether by land, air, or and, veterinary and economic security. or the group of diseases considered suitable proliferation and disarmament is clearly sea.28 The Proliferation Security Initiative is for biological warfare. However within the a priority for the Member States and EU however only one tool in a suite of needed In 2001, when the Netherlands suffered a wider framework of emergency disease institutions as expressed in the newly interventions to prevent the possible use relatively limited outbreak of foot and mouth planning natural and deliberate zoonotic emerging EU Strategy on WMD defined of WMD and in a wider sense an act of disease, statutory issues over authority disease outbreaks and general threats to in the EU Security Strategy and the two bio-terrorism. It does serve as a practical immediately emerged between European public health security, the transatlantic documents mentioned in the Thessaloniki mechanism for transatlantic engagement. Union regulation on designated quarantine partnership would be well served by sharing conclusions: the ‘Basic Principles’ and indicators, vaccination policy, and transport lessons learned over wider public health the ‘Action Plan to implement the Basic and border closure. Belgium and Germany emergencies. Although war games may not Principles for an EU Strategy against War Game Scenarios: closed their borders, immediately halting all reflect the full spectrum of issues we would the proliferation of weapons of mass imperfect but necessary? trade; the Netherlands initially instituted a likely face during such an event, they are destruction.’ Achieving a single Common three Kilometer quarantine around infected perhaps imperfect means of highlighting the Foreign Security Policy budget line on ‘non- War-game scenarios are often based on farms while states such as Germany more glaring failures of policy and capability proliferation and disarmament’ would be an ‘worst-case.’ Critics of Atlantic Storm, Global insisted on a 10 Kilometer radius, Dutch gaps. The most efficient way of assessing our important measure of this commitment and Mercury, Dark Winter and other war-games veterinarians began vaccination in direct capabilities in light of non conventional terror serve to build on the achievements of the based on a Category A pathogen outbreak, violation of EU law at that time (the law has threat is to carry out simultaneous action Community in this area. 26 often propose such gaming is not realistic now been revised to allow for vaccination on several levels: deterrence (though in the and conducted to sow the seeds of panic or with six month restrictions on trade). If case of terror, effectiveness is questionable), Limits of the non-proliferation regime nations challenge EU authority and regional prevention, and preparations for responding 27 Verdirame, Guglielmo, “The Case for Forcible Counter-Prolifera- 29 prompted the US and ten allies, including tion”, The Nixon Center, 2005, URL: http://www.inthenationalinter- discrepancies obstruct timely response to the fallout of an attack should one occur. est.com/Articles/Vol3Issue4/Vol3Issue4Verdirame.html 26 Quille, Gerrard, “EU Member States Pledge 5 Billion Euros to 28 Winner, Andrew, C., “The Proliferation Security Initiative: the New for emergency animal disease crisis how 29 Stevenson, Johnathan, “How Europe and America Defend Them- Tackle WMD Proliferation”, European Security Review, Interna- Face of Interdiction”, The Washington Quarterly The Center for selves,” Foreign Affairs. Council on Foreign Relations, March/April tional Security Information Service, No.20, December 2003. URL: Strategic and International Studies and Massachusetts Institute will they cope with a highly orchestrated 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- http://www.isis-europe.org/ftp/Download/EU%20Member%20State of Technology, (Spring) 2005. URL: http://www.twq.com/05spring/ p20/jonathan-stevenson/how-europe-and-america-defend-them- s%20pledge...WMD%20proliferation.pdf docs/05spring_winner.pdf deliberate disease outbreak of a Category A selves.html
NEW DEFENCE AGENDA 41 As zoonotic and emerging diseases pose a outbreak of disease, seems to be slipping from Angola) were investigated by the security preparedness. Although agro- greater and greater challenge to public health by without much notice or concern over its WHO and determined not to be infected terrorism and food-borne zoonoses pose authorities and international health security potential spread even as it moves closer to with Marburg. International health threats a serious threat to public health with the how can we hope to counter deliberate major cities where international travel could and bio-terrorism must be responded to exception of genetic modification and an disease (bio-terrorism) when we do not present real risks to public health security. in a much wider, integrated context. As advanced delivery system most would not even have regulations covering notification of This would seem to be a good opportunity of 13, May (2005) there were reported 8 have the same kill ratio as a VHF or other Class A and B zoonoses which pose a direct for transatlantic dialoging on common people dead in the Congo from symptoms Cat.A fully weaponized disease.. From an public health threat? biological threats just as the SARS-CoV similar to Ebola or consistent with a Viral economic standpoint which unfortunately outbreak was a wake-up call to western Hemorrhagic Fever. Ebola’s worst outbreak often takes precedence over public governments to enhance surveillance and in 1995 killed more than 250 people in health security, food-borne zoonoses or A Real Time Public response capacity. Transitional states, the Congo. Cuvette region suffered 120 agro-terrorism would be devastating, Health Security Crisis: developing states and failed states should fatalities from Ebola the same region where there are however often treatments be serious considerations when we assess the 8 casualties have thus far occurred. Risk Communication, Angola: Marburg Hemorrhagic Fever Outbreak: our defences against biological terrorism Minor Emergency no.05ME021; Bulletin No 3; Reported Response and and basic emerging diseases. Although few Emerging and reemerging disease must Cases from October 2004 to April 2005 Preparedness? economic interests are at stake in Uige arguably be included in public health planning Month Year Cases Reported Deaths Reported province the potential spread of a Category for emergency and deliberate disease October 2004 3 3 A Viral Hemorrhagic Fever is alarming. management; a structure complimentary to November 2004 4 4 “Syndromic diagnosis—[is] nothing but a While the US, Canada and Europe consider most public health systems. An integrated December 2004 7 7 big charade, by the time you start getting how to work together to prevent the spread approach to vaccine and therapeutic January 2005 20 20 blips in emergency rooms, it’s too late.” of disease the outbreak of Marburg seems investiture must have a dual function both February 2005 31 30 Dr. C. J. Peters, former head to have slipped from the radar. to serve normal disease outbreaks as well March 2005 53 47 of the CDC’s top security lab.30 as potential deliberate disease epidemics. April 2005>20 April 148 133 Unlike recent Avian Influenza outbreaks The transatlantic relationship could be Total 266 244 The Marburg outbreak31 in Uige province, across Asia which posed a significant positioned to strengthen these areas critical This represents a fatality rate of 91.7%32 although a presumed natural occurring economic and potential public health to shared public health security policies. threat, the Marburg outbreak which as available and the symptoms are generally
30 Gottlieb, Scott, “Wake up and Smell the Bio-Terror Threat”, Home- of May 6th claimed more than 277 lives, Viral Hemorrhagic Fevers and other not as severe as the crash and bleed out land Dangers, The American Enterprise Institute, January/February 2003. URL: http://www.taemag.com/issues/articleid.17342/article_ with 316 persons infected has reduced Category A bio-warfare agents such as phase from VHF, smallpox or blackpox.. detail.asp 31 Marburg hemorrhagic fever isn’t as much feared as its cousin Ebola economic significance but potential public Anthrax do occur with some regularity How effective are current tropical disease hemorrhagic fever. But in fact, they’re hard to distinguish [Clinically they are associated with similar disease symptoms, but the 2 virus- health security risks. The first cases in throughout many parts of the world. management strategies in the EU? What es do not cross-react antigenically and are easily distinguishable by serology and RT-PCR assay. - Mod.CP]. In both cases, victims Uige were reported last October in They pose a significant health risk and regulations are in place to test for Marburg bleed to death, often from every orifice and every organ. Few infec- tions are as deadly. That’s why the WHO, the US Centers for Dis- 2004 since then there has been a steady should be considered in a wider bio- at international airports across Europe ease Control and Prevention, Health Canada and the medical aid group MSF (Medecins sans Frontieres) are rushing to Angola. The increase in the infection rate and fatalities. defence public health protection strategy. today? Should we be concerned that such international response to the outbreak in Angola began one month ago, on 22 March. The features of Marburg hemorrhagic fever, and the conditions in Angola, have been an extreme test of international In early April, nine people were placed in Unlike smallpox, there is no treatment an outbreak is not only occurring but not capacity to hold emerging diseases at bay. The outbreak in Angola is the largest and deadliest on record for this rare disease, which isolation in Italy following contact with an for VHF’s and their classification as bio- is presently showing a case fatality rate higher than 90%. For com- 32 International Federation of Red Cross and Red Crescent Societies, Ango- parison, outbreaks of the closely related Ebola hemorrhagic fever infected person who died. In Portugal two warfare agents should be taken into la: Marburg Hemorrhagic Fever Outbreak: Minor Emergency no.05ME021; have shown mortality rates ranging, according to the virus strain Bulletin No 3; 25, April, 2005. URL: http://www.ifrc.org/cgi/pdf_appeals. involved, from 53% to 88%. World Health Organization suspected cases (people who had arrived account when structuring public health pl?05/05ME02103.pdf
NEW DEFENCE AGENDA 43 being overtly communicated to the public them.35 Bio-terrorism is a security and and quarantine.36 As Akerman and Moran fully consistent with current public health by public health authorities responsible for public health issue which is not necessarily contend in regard to the technical ability security policy is preferable. To this end, the protecting European citizens? true of emerging or pandemic diseases. of terrorists to engage in future acts of European Union has endeavored to increase biological terrorism, some experts contend it’s surveillance of disease outbreaks via its “As we face the possibility of designer Although preparing for bio-terrorism that previous technical obstacles to obtaining network approach. As Julius Weinberg states, agents, facilitated by advances in requires national investment in a range of or developing biological weapons has “Many of the European networks have shown biotechnology, we must reconsider our capabilities (i.e. surveillance, diagnostics, eroded, and biological weapons capability that by combining data from various different current extremely conservative and capacity) and a suite of security based is most likely within the reach of at least countries they can detect events that would cumbersome system for development counter measures one of the primary a certain subset of terrorist groups. The not have been detected any other way, such as and production of vaccines….Failure to means available to us is the use of group most commonly cited as being likely for the Legionella and Salmonella networks.” prepare is not an option; the potential vaccine and therapeutics as a deterrent. to “overcome the technical, organizational (Weinburg admits, however, that the system impact of biological terrorism on our Creating a national vaccine strategy with and logistical obstacles to WMD37 is the Al failed to achieve a consistent response across society is too great,”33 comprehensive legislation to ensure public Qaeda network, which is reported to be different countries to the H5N1 influenza health security is a significant advantage pursuing several types of WMD including strain.)39 Weinberg advocates the use of Dr. David Franz and Dr. Lance Gordon, against the use of disease as a weapon biological weapons. The transatlantic “effective generic public health systems” co-chairs of a national working group of mass destruction. In this respect the relationship in identifying common threats, that deal routinely with a range of infectious convened by the Chemical and Biological United States has made tremendous strides preparing to respond and contain disease diseases - not specific bioterrorism-response Arms Control Institute (CBACI) to develop a toward insuring public health protection. As outbreak could not be more critical. Since systems - because “you actually don’t know national bio-defense vaccine strategy. war scenarios have tended to demonstrate well over 30 previously unknown infectious what the next bioterrorism event is going to the need to plan for such an event is critical agents (including several new hemorrhagic be.” “You can build endless P4 facilities against even if nations disagree on the exact extend fever viruses and new highly virulent strains the day that someone releases a very virulent Policies for Preparedness and nature of the threat. of streptococci) have been identified since pathogen, but laboratories have to be doing 1973, it is imperative our public health something in the meantime.” Before September 11, only six European The incubation period (1 day to 2 weeks) infrastructure and surveillance systems countries – France, Germany, Italy, Portugal, associated with most biological agents be structured to recognize both naturally “Even if al Qaeda focuses only on American Spain, and the United Kingdom – had between exposure to the infectious agent occurring and intentionally released installations in Europe, should its operatives specific counterterrorism laws (as distinct and the onset of symptoms is unique infectious agents.38 use WMD, the consequences will be grave from ordinary criminal codes).34 Some of among weapons types; preparedness can for the population at large. These factors these six have since strengthened their laws make all the difference to the outcome of For most European Member States suggest that with respect to homeland still further or improved enforcement; other a bio-terrorist attack. Unlike weapons with launching programmes solely for countering security, Europeans and Americans will countries such as the Netherlands, which more immediate effects such as explosives, bioterrorism is not an option as it may be for remain dependent on one another.”40 did not have such laws or counterterrorism there is the possibility to mitigate the the United States. Rather, improving capacity programs, have enacted and implemented effects through counter-measures including rapid detection, treatment with 36 Akerman, Gary and Moran, Kevin S., “Bioterrorism and Threat As- sessment”, The Weapons of Mass Destruction Commission, No.22, 33 Chemical and Biological Arms Control Institute, “CBACI Releases 39 Clayton, Julie,” Europe in Disunion about Proposed Disease Cen- Stockholm, Sweden, November 2004. URL: http://www.wmdcom- ‘Roadmap’ for National Vaccine Strategy”, press release, 29, Sep- antibiotics, therapeutics and/or vaccines ter”, BioMedNet, 3 May, 2002. URL: http://www.vaccinationnews. mission.org/files/No22.pdf tember 2004. URL http://www.cbaci.org/press/release8.htm com/DailyNews/May2002/EuropeDisunionInfect.htm 37 Simon, Steven and Benjamine, Daniel, “America and the New 34 Stevenson, Johnathan, “How Europe and America Defend Them- 40 Stevenson, Johnathan, “How Europe and America Defend Them- Terrorism”, Survival, Vol. 42, No.1, Spring 2000 pp. 59-75. URL: selves,” Foreign Affairs. Council on Foreign Relations, March/April selves,” Foreign Affairs. Council on Foreign Relations, March/April http://www.eusec.org/su0001te.pdf 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- 2003. URL: http://www.foreignaffairs.org/20030301faessay10340- p20/jonathan-stevenson/how-europe-and-america-defend-them- 38 Cassell, Gail, Testimony on the Department of Homeland Security, p20/jonathan-stevenson/how-europe-and-america-defend-them- selves.html 35 Ibid., Stevenson, 2003. American Society of Microbiology July 9, 2002. selves.html
NEW DEFENCE AGENDA 45 PANELIST CONTRIBUTIONS
Conclusion The transatlantic discussion on perception of Brigadier Ian Abott, OBE Although the numbers were very threat and counter-measures to interdict an Director, Policy and Plans Division high, even one “event” can be highly Rapid advances in life sciences and the act of bio-terrorism at an early stage reflected European Union Military Staff disruptive. The following description anticipated developments in biotechnology, general criteria similar to that proposed is over simplified but gives an example genetic engineering, and other advanced by the American Society of Microbiology of some of the factors and sequences technologies not only have the potential to essentially that we need to: I welcome the opportunity to place this involved. Several hours and days are lost produce new drugs for serious diseases, but complex subject in context and to give some as part of the identification and clean up also pose tremendous security risks for fear Develop an integrated set of strategies; impression of the consequences arising from tasks are undertaken. Rooms, computers that terror organizations may exploit the Prevent nations from acquiring bio- this form of threat. We know for some and papers are not available. People are technology to cause diseases, epidemics, weapons in the first instance, individuals, organisations and governments stripped, their clothes, car keys, money and other biologically related damage.41 Dismantle existing programs and this subject and the asymmetry aspect in the and credit cards are quarantined. Minds Several counter-measures for responding capabilities where proliferation has contemporary threat spectrum are not new. are affected; public perceptions to bio-terrorism are complimentary to already occurred; We all acknowledge that public discussion are shaped. The blue light emergency basic public and veterinary public health Deter the use of biological weapons, and, and thinking on this subject was precipitated services are initially totally committed. security. Building capacity to respond to Ultimately, put in place countermeasures by the events of 11 Sep 2001. But possibly we What the substance is and where it is are natural outbreaks of disease, research on that can rapidly detect and effectively need reminding that in addition, there were unknown. CBRN contamination suits and emerging and re-emerging diseases including defend against such use. ‘anthrax’ attacks that took place in October breathing apparatus hinder progress. The Category A biological warfare agents such as of 2001 in the US and were copied as “white weather, and particularly the wind strength Viral Hemorrhagic Fevers offers a number In the long term, the only way to defend powder” attacks in other countries. I do not and direction, plays a significant part. A of benefits. However in the EU building against bioterrorism is through a combination want to be drawn on whether a national or hot zone, with inner and outer cordons capacity among the member states must of constant surveillance, accurate diagnostics a foreigner conducted the attack; significant is established. First aiders, hospital A&E still be increased to better partner with the to identify threats as early as possible and though that might be to the threat profile. departments, pharmaceutical laboratories, international community. Europe still has only continuous innovation to provide high Instead, I wish to concentrate on the police, fire and military capabilities are a few locations to perform pox diagnostics. quality vaccines and drugs that can be useful effect induced, the crisis management engaged. The population from the areas In a outbreak where rapid processing may against any attacks that do occur.42 Research required, consequence management issues directly affected and then downwind of be necessary according to Matthias Niedrig, related to bioterrorism is inextricably linked raised and remedial measures identified as the cordon are affected and moved. Then of the Robert Koch Institute, even 50 to 100 to that of naturally occurring infectious these areas seem to me to offer the best once clear, and remember sit took over one samples would be problematic in terms of agents and development of new antibiotics, potential to harness your views in order to year to declare all of the papers clear of a quick diagnosis. What should be our goal antivirals, diagnostics and vaccines; the address today’s meeting. infection after the anthrax contamination, then within a wider international framework research and development of technologies more time is needed to regroup and for developing counter-measures to bio- for bio-defense should be synergistic and As a model to orientate our thinking I ask reconstitute the emergency services terrorism? Although the transatlantic not duplicative.43 you to consider what might be involved in a capability and readiness to respond again. debate took in a wide field of related areas “white powder” attack which, for background, narrowing the debate to bio-terrorism happened several hundred times in the UK And this brings me to a key element. instead of terrorism was less transparent. in the year following the anthrax attacks Confidence, I firmly believe that the
41 Friedman, David, “Preventing the Proliferation of Biological Weap- in the US and generated over 200 events centre of gravity in a democracy is 42 Cassell, Gail, Testimony on the Department of Homeland Security, ons: Situation Overview and Recommendations for Israel”, Strate- American Society of Microbiology July 9, 2002. gic Assessment Vol.7, No.3, Jaffee Center for Strategic Studies, Tel that required serious investigation and the maintenance of public confidence Aviv University, December 2004. URL: http://www.tau.ac.il/jcss/sa/ 43 Cassell, Gail, Testimony on the Department of Homeland Security, v7n3p5Fri.html American Society of Microbiology July 9, 2002. engagement with the emergency services. in the government. In open societies
NEW DEFENCE AGENDA 47 this brings an associated challenge of “Just in Time” rather than “Just in Case” reaction, shape public perceptions Georges C. Benjamin, MD engagement with the public over the threat, methodologies and practices. This means and so influence political thinking, Executive Director crisis management procedures, plans and that there is very little or no reserve in the policy and strategy. We appear to American Public Health Association Consequence Management Capabilities. national and international supply chains. be immune to some losses; regrettably Establishing and maintaining confidence For instance, I recall a case where a global hundreds of lives are lost every day on the involves several lines of development. Some energy plc found it was unable to move its roads, aircraft are lost. But the Tsunami, Strengthening Public Health: of which I will briefly cover now. oil products as it did not directly employ the gas attack on the Tokyo Tube system Homeland Defense the drivers of its fuel tankers nor did it own and the Anthrax attacks in the US The first is Public Information. Effective the vehicles that carry their logo as they are seize the mind. Consequently we must Four important principles are guiding Nation and international Public Information leased from another company. Elsewhere consider new and novel forms of attack current efforts to strength the U.S. public policies are key but they appear to we see a taxi drivers strike at the airports and prepare our minds and those of the health system. First, our knowledge on suffer from oscillating between sharing in the Balearic Islands cause charter decision makers and public. Returning to bioterrorism is based on experience. information or scaring the target audience. aircraft to be grounded on the American the centre of gravity; the terrorist will be The U.S. has experienced at least two In many countries now questions are West Coast. Consequently as the world successful if the government losses public bioterrorism incidents in the past twenty being raised on the legality and suitability has become more interconnected and confidence. I think the Madrid bombing years: the Rajneesh’s use of salmonella as of national counter terrorist measures societies more complex, there has been a was a pertinent example of my thesis. a food contaminant in 1984 and the series introduced after 11 Sep 2001. It seems growing vulnerability to natural and man Consequently governments and relevant of unattributed anthrax mailings in the fall that it is very difficult for democracies to made “shocks”. parties from the public and private sector of 2001. Second, the practice of public find policies, strategies and procedures must develop, understand and practice health has fundamentally changed as a that are pragmatic and achieve a balance Trade patterns, commercial practices, crisis management procedures, have result of multiple factors. Third, there is between being proactive or reactive. legislation and multinational contracts have effective and resilient Business Continuity evil in the world. Malicious actors can seek produced a global web that binds us all. And Plans to sustain for the maintenance to use dangerous organism with the goal of Another key factor is the engagement of this brings me to my last key ingredient. I of essential services for the public and creating mass- fatalities or mass disruption. the private sector. For many European believe the terminology Weapons of Mass private sectors and society at large. This Finally, having said that, nature is the most States, the last 60 years can be categorised Destruction (WMD) is misleading - even planning should begin with what effect dangerous actor in that outbreaks of new as the conversion of a nation state from the expression CBRN may be unhelpful as I has been produced, and what capabilities and reemerging infectious diseases are being organised for total war to one that look inside my son’s fridge at university and and actions are needed in order to return occurring as a result of man’s interaction is best orientated to meet the challenges think the cultures growing there on his food to normality as quickly as possible. with and use of the environment. and opportunities provided by democracy and drink indeed warrant being considered and free trade. As a result, services that as a risk to life! Hopefully this reminder of some of the These four factors are converging to create a were once considered as critical to the associated factors involved will help place new operating environment for the practice maintenance of government control and But returning to the expression WMD, the subject and your deliberations in of both medicine and public health. In the power, have changed ownership and instead, I consider the challenges we face context in order to address the aim of past, public health practitioners and the have moved into the private sector. The now are best analysed and managed as today’s meeting. public health system were largely invisible to situation though becomes more complex being weapons or actions that seek the public. With the emergence of infectious as government and corporate influence mass effect. From national examples I disease as a known threat to security, public has been eroded as market forces and the am convinced that the more novel the health has become increasingly prominent search for competitiveness have introduced event, the more it will stimulate a as the front line of defense against this
NEW DEFENCE AGENDA 49 threat. As a tool of security and defense, ingenuity like the highly deadly form of hiring new people, providing education and Recovery from the immediate and long- public health has become a 24/7 operation Monkey pox created by accident in an training opportunities for staff, providing term effects of the outbreak. with the goal to provide immediate results. Australian biotechnology facility. the tools they need to operate in this new This has also meant that public health is environment, and supporting infrastructure Federal, state, and local governments have increasingly intertwined with “big P” politics The other factor placing public health at the – things like new facilities and new linkages been investing in the public health system and fundamental debates about national center of national and homeland security is with non-traditional partners like the law significantly in the period since the events budgets and budget allocations. Where the danger of bioterrorism and biological enforcement community. To be successful, of September 11th, 2001 and the anthrax public health in the past focused on well- weapons. As a direct result of the terrorist creating a public health system for the 21st mailings of the same year. A key question planned, well-defined public information attacks of September 11, 2001 and the century requires structural reform at local for the public health community, political campaigns focused on public education and anthrax mailing in the autumn of 2001, level and increased investments into basic leaders, and public at large is “are we prevention, this new environment is taxing security dominates the national agenda. in public health research. It also requires prepared?”. In other words, has investment the system with too much information The possibility of biological weapons use sustained investments to increase capacity in public health capacity building efforts and an inability to speak with “one voice by terrorist organizations and nation- and changes in the way Federal government provided the capabilities the nation and one message”. Last, and perhaps most states has risen to the top of listed threats provides funding to state and local public needs to protect itself from bioterrorism, importantly, the practice of public health has to national security and homeland security. health agencies. biological weapons, and the broader by necessity become increasingly global in Strategies for responding to the threat of range of infectious disease threats? The scope, to keep pace with the global nature bioterrorism have emphasized elements of To provide the necessary defense, answer is more complicated than a simple of threats to public health. prevention and protection. Increasing the investments in public health must enhance “yes” or “no”. Preparedness is a process, capacity of the national public health system response capacity across all levels of and not a point in time. The direction Two issues have placed public health at the to respond effectively to an outbreak government; Federal, state, and local. The of this process is determined largely by center of national and homeland security resulting from biological weapons use is capacity to respond is comprised of several answering the question of “preparedness and are producing this new operating the cornerstone of the national strategy elements. These elements include: for what?”. It is the complexity of the environment. The first is concern about the to defend the nation against biological challenge posed by infectious disease – threats posed by emerging diseases. This weapons. Importantly, the results of these Prevention; the number and variety of disease causing includes the re-emergence of infectious capacity building efforts also provide the Disease detection and the ability to agents, the potential for the use of disease diseases: perhaps as a result of lapses in nation with the cornerstone of defense discern unusual patterns of disease; as a weapon, and possibility of new and public health, evolutionary changes in against all infectious diseases – including Epidemiological investigation to unknown diseases created by nature and the organism that helps it to overcome naturally occurring outbreaks. determine the extent and cause of the man – that make the achievement of true existing vaccines and treatments, or outbreak; preparedness difficult if not impossible. the reintroduction of dormant diseases There are multiple challenges to ensuring Laboratory testing to confirm the Rather than thinking about creating a resulting from environmental changes. the public health system of the 21st disease agent: public health shield against infectious This includes the possibility of pandemic century can respond to the full range Provision of information regarding the disease, our goal should be the creation flu, sporadic outbreaks of hemorrhagic of infectious disease threats. Effectively outbreak to key stakeholders; and maintenance of a public health system diseases, hantavirus, etc. It also includes managing the growth to ensure it provides Provision of treatment and the ability to that can translate the chaos of disease the emergence of completely new and real improvements in capability is critical. contain the outbreak through focused outbreaks into controlled disorder. previously unseen infectious diseases; Increased spending on public health must public health intervention; including those created by nature like SARS be used effectively in building and sustaining Links with external supporters and What are the results of on-going efforts and new organisms created by human key elements of infrastructure. This includes partners; and to build up the U.S. public health
NEW DEFENCE AGENDA 51 infrastructure to date? The public health Gerald L. Epstein the (fortunate) paucity of actual historical or major biological attacks. Maybe not enough system has become less reactive – catching Senior Fellow for Science and Security intelligence information regarding biological of today’s terrorists took high school biology. up to events, and increasingly proactive. Center for Strategic and International threats, and by the limitations that we Tomorrow’s will - and their high school Preparedness and infrastructure building Studies, Washington, DC would face in using such information even biology classes will be much more potent efforts have produced rapid, frequent, and if we had it. than today’s. We cannot bet our countries broad-based communication among and that whatever restraints have kept terrorists between Federal, state, and local public Threat Perceptions, Threat Limitations of Historical Analysis. The from pursuing biological weapons will health agencies. It has also increased Assessments, and US/EU enormous gulf between what might be persist indefinitely. Indeed, it would be very communication with external partners Cooperation in Biodefense possible in the future and what has been dangerous to assume that the future will look and supporters. Recognizing the global seen in the past in terms of biological attacks like the past when both terrorist capabilities scope of the infectious disease problem, I’d like to talk about two factors that will leaves room for widely disparate differences (in terms of technologies that may become there is an increasingly global approach to have a very important effect on the degree in perceived threats. Indeed, few areas accessible to them) and terrorist intentions public health. As the public and political to which the United States and Europe will besides biological threats have so great a are dramatically changing. leaders have focused on the public health be able to cooperate on biodefense: our disparity between the proven capability to community to provide information and relative perceptions and assessments of the do harm, and the number of actual attacks. Limitations of Intelligence Analysis. But the answer their questions about health threat. The degree to which bioterrorism We know for sure that biological weapons, problem is even worse than that. Even if we and infectious disease, knowledgeable and biological weapons are perceived to be when prepared for effective dissemination had perfect intelligence information about and capable spokespersons are being significant security threats will affect each in large enough quantities, can kill over the current state of the bioterror threat - developed within the public health party’s willingness to invest resources in large areas. The capabilities to place many if we knew the intentions of every person community. Investments in people, facilities, biodefense, and the nature of each side’s thousands of lives at risk were demonstrated seeking to do harm with biological agents, and technology are producing new science threat assessment will help structure that decades ago. Although these programs and we knew perfectly exactly what they at record speed. Public health is using all side’s biodefense program. Of course it is not drew on the resources of nation-states, half were capable of - we would not necessarily available systems and resources to their full necessary for the United States and Europe a century of advances in biotechnology - know how to structure a biodefense potential. Finally, and most importantly, to have identical threat perceptions and one of the most rapidly advancing realms of program that may take years to develop we know that recent improvements in the threat assessments in order to successfully human endeavour - goes a long way towards countermeasures. Said another way, exactly public health system and its associated collaborate - political history is replete with making these capabilities available to non- how close terrorist groups are right now to infrastructure have saved lives! situations where parties, having different state groups. We know that the technology, the capability to conduct a major biological overall perceptions (not to mention values materials, and expertise required to attack matters if we want to know how likely and objectives), have worked together in produce biological weapons are available it is that such an attack will take place in the some area of common interest. But given to those terrorists who are sufficiently near future. However, looking at the several that countering biological threats is too motivated and skilled to pursue them; years that our defensive preparations will large and too inherently international a essentially all the equipment, materials, and take to implement, the details of today’s problem for any one nation or group to expertise have legitimate application or are threat are less important than the realization solve alone, it is important that we arrive at available to be found (although they will not that the rapidly increasing capability, market some common understanding of what it is all be typically collected in any single place). penetration, and geographic dissemination we need to do together. However, deriving And we know that enemies exist who are of relevant biotechnical disciplines will threat assessments - let alone coming to eager to kill in vast quantities. What we are inevitably bring weapons capabilities within agreement on them - is complicated both by not sure of is why we have not yet suffered the reach of those who may wish to use
NEW DEFENCE AGENDA 53 them for harm. If it takes close to a decade of potential threat agents very far, spending David R. Franz, DVM Of course, this was a serious mistake. For to develop and license a new therapeutic the kind of resources that have been Midwest Research Institute much of the period until the late 1980s, the or vaccine, it is not today’s threat but the required to develop such “point” solutions, United States knew little of the enormous threat a decade from now that we need to before any conceivable biodefense budget Soviet BW program; a program the Soviets counter. And given how much easier it is to gets exhausted. The Evolution of Thought on actually scaled up throughout the 80s after pose a threat than to counter one, the threat Biological Defense in the United they ratified the BWC. ten years out may not even materialize In the long run, the only way to match finite States until eight or nine years out. So we have a resources against a seemingly infinite set of The United States and the Soviet Union fundamental problem in principle in trying threats and vulnerabilities is to develop a Pre-1990: A back-burner concern continued to openly possess large stocks of to base today’s countermeasures programs vibrant, flexible, and responsive biodefense offensive chemical weapons (CW) during on today’s intelligence information. system - on that can respond to threats In 1969, the United States unilaterally halted much of this period. As a result, the United as they materialize. This is a challenging its offensive biological weapons (BW) States continued to develop medical and I don’t want to sound like I am saying task - we don’t necessarily have the basic program. In 1972, it signed the Biological non-medical countermeasures to CW that intelligence is useless - it is critically science and technology in hand that will be Weapons Convention (BWC). In 1975, it agents. Adding to the low priority place important that we use every available means necessary for such an approach, let alone ratified the convention. When President on biodefense, we assumed our passive to disrupt, interdict, or prevent ongoing the financial commitment, logistical support, Nixon decided to stop the offensive chemical protective gear – gas masks, efforts to develop and use biological and regulatory mechanisms that will also program, his statement had explicitly protective suits, etc. – would provide weapons. However, as we look further out be required. But we will certainly improve directed the continuation of defensive adequate protection against the poorly into the future, intelligence will be less and our prospects of putting such a system programs against biological threats. In reality, understood biological threat. less useful as a tool for planning our long- in place if the United States, Europe, and the United States relegated development term defense strategy. other scientific and technological powers of BW defenses to relatively low priority. This period could be characterized as one are all able to contribute effectively to the Research on biological weapons detection of naïveté and intelligence failure. Implications for Biodefense. At the same task. And to recap my earlier remarks - it capabilities essentially stopped detection time, given the vast array of possible ways in isn’t necessary that we all view the threat in the 60s. For much of the period, the 1990-1998: Only protecting the military which bioscience and biotechnology can be identically. But unless we both share some United States maintained a small (ca. $15- on the battlefield used for harm - and the certainty that new common sense of urgency, and have 20M/yr) medical countermeasures research science and new technology will further commensurate views on certain elements program housed at the U.S. Army Medical The 1991 Gulf War triggered new interest expand those possibilities - we cannot of how to respond to it, we will find it Research Institute for Infectious Diseases or in chemical and biological weapons defense design defenses to counter every possible difficult to make much collective headway. USAMRIID at Ft. Detrick, MD. within the Department of Defense (DoD) mode of attack. We have to prioritize our – particularly in passive biological defense. investments. Some initial priorities seem Many assumed the ban on biological Revitalized biodefense efforts mobilized at clear - a few specific threat agents, such as weapons had eliminated much of the BW Edgewood Arsenal, Dugway Proving Ground, anthrax and smallpox, are so dangerous threat. Although a suspicious outbreak of and at Fort Detrick. Edgewood and Dugway that it is worth developing specific remedies inhalational anthrax occurred in the Soviet focused on environmental detection, physical for these, even if all that accomplishes is to Union in 1979 and there was concern protection and decontamination. Ft. Detrick, bump terrorists into using something else. If regarding the possible use of toxin weapons primarily through USAMRIID, focused on they don’t use anthrax or smallpox, we’ve by the Soviets in Cambodia shortly thereafter, the developing and testing of vaccines, drugs, gained a lot. But one can’t work down lists we did little to improve our defenses. and diagnostics.
NEW DEFENCE AGENDA 55 During this period, the doctrine of nuclear, essentially unfunded for biodefense. With Defense began the first national program the political support for such programs was biological and chemical (NBC) defense was its nuclear stockpile mission reduced, the to provide training and equipment to local lacking until President Clinton read Richard viewed as an interrelated whole. Experts in U.S. Department of Energy (DoE) began first responders to improve their ability to Preston’s “The Cobra Event,” a fictional chemical detection - where we already had collaborating with DoD laboratories on respond to terrorism incidents involving the account of domestic bioterrorist activity. significant capabilities to warn troops before biodefense research. DoE personnel was use of weapons of mass destruction. concentrations reached toxic levels – were placed in key DoD leadership positions As a result, the U.S. Department of Health retooled to detect “chem-bio” agents. relating to BW defense. The complex In the event of an actual terrorism incident and Human Services (HHS) was given Drawing largely from the experience of of national (DoE) laboratories began in the United States, the Federal Response approximately ca. $150M to develop a chemical weapons defense, the concept of contributing its expertise to biodefense Plan and other policy documents provided civilian biodefense capability. These dollars “detect to warn” sensors and protective research projects. primary responsibility for crisis management funded laboratory upgrades, education clothing were adopted as the likely solution (investigation, security, prevention, etc) to and a fledgling national pharmaceutical to the “bio” problem as well as CW defense. Some in the international community were the U.S. Department of Justice (DoJ). These stockpile. The increased role of public Seven to eight years of basic research and suspicious of U.S. intentions related to the same documents and policies assigned health in national defense probably resulted field testing of sensors and protective increase of our biodefense R&D effort, our primary responsibility for consequence from the general change in our appreciation, scheme produced the realization that “bio” continued work with dangerous pathogens management (decontamination, search not of the magnitude of the threat, but the was fundamentally different from “chem.” and toxins, and our unwillingness to agree to and rescue, medical care, site clean up and character of the solution. and “detect to treat” might be the best any type of enforcement regime or legally- restoration, etc.) to the Federal Emergency achievable result for the near term. binding protocol. This “post-Iraq” period Management Agency (FEMA). With the start of a public health-focused was characterized by increased awareness civilian biodefense program (several years In the area of medical countermeasures, the of the battlefield threat and the widely Until the fall of 1998, these domestic after the sarin chemical attacks on the Tokyo DoD medical tech base developed 10-15 held belief that physical countermeasures prepared efforts reflected the military’s subway and a string of “anthrax” hoaxes new vaccine candidates, but took them only were the key to protection of the force. perspective that the response to a chemical that started in 1997), officials and experts through pre-clinical testing (most in non- Until 1998, little program activity concern incident would be similar to a biological within the Department of Defense were human primates). DoD research efforts focused on providing civilian biodefenses. incident. Until this point in time, “bio” was thinking more about biological terrorism also developed vastly improved diagnostics perceived by many to be a new form of in our cities than biological warfare on and reference laboratory identification 1998-2001: Protecting civilians and seeking “chem” and therefore the response to a the battlefield. The DoD’s budget for capabilities that included chain of custody public health “buy-in” bioterrorism incident was largely a public environmental detection programs and and forensics support. These capabilities safety response on a HAZMAT response the medical tech base budget doubled in were exploited extensively during the As a result of the Sarin gas attack in the Tokyo template, not the public health threat that 1998 to approximately $40-50M annually. numerous “anthrax hoaxes” occurring subway, the bombing of the Murrah Federal it is. That perception changed gradually However, neither the complexities nor the during the late 1990s. Building in Oklahoma City, and the 1993 as public health experts in and out of costs of advanced development of medical attempt to topple the World Trade Center, government were growing increasingly countermeasures (vaccines) were well By 1997, the entire US budget for government officials and non-government concerned that preparedness programs appreciated. Vaccine candidates remained biodefense had reached $137M. All of that experts began expressing growing failed to understand the nation’s public in the tech base and years from licensure resided within the Department of Defense. concerns that terrorists would acquire health system would be the “front line” by the Food and Drug Administration. The The U.S. Centers for Disease Control and and use weapons of mass destruction. In of defense against bioterrorism. These DoD’s actual mission did not have a clearly Prevention (CDC) was involved peripherally 1996, pushed by a mandate and funding experts called for increased resources to defined mission during the response to given its public health mission and was provided by Congress, the Department of support public health capacity building, but domestic bioterrorism event, and our non-
NEW DEFENCE AGENDA 57 military security agencies were not focused the National Institutes of Allergy and In the end, the transition from thinking Potentially extremely small footprints on biological terrorism defense. Infectious Disease (NIAID) – part of HHS’s about and preparing to counter a biological (the weapon and the lab or production National Institutes of Health - received TERRORISM threat, vs. a traditional facility within which it is produced); In the international policy arena, the $1.75B for medical countermeasures biological WARFARE threat, had been U.S. increased efforts to encourage research and development and vaccine difficult. 10s of suitable agents available in nature criminalization of biological weapons production; a larger percentage funding thus not ‘outlawable’; development and use and to expand increase for bioterrorism defense than it had 2005-Present: Settling in for the longer term international norms condemning the use of received during the HIV-AIDS pandemic Low-tech (or no-tech) is required biology for other than legitimate purposes. that started in the ‘80s. Importantly, NIAID After a rush to harvest real and perceived for use, especially in the case of the harvested the best of the DoD tech base “low-hanging fruit” the relatively quick contagious agents; During this period, the United States had vaccine candidates of the 90s and moved and easy capability improvements in the started to appreciate and understand the the next generation anthrax and smallpox area of civilian biodefense and a boom in Vulnerable human, animal and plant nature of the biological terrorism threat against vaccines into advanced development and the number of bioterrorism ‘experts’, the populations exist in our free societies; our civilian population, and that the nation’s production. CDC grants to state and local nation is beginning to better understand public health infrastructure was an important public health agencies increased substantial the complexity of the biodefense challenge. Best available medical defenses against part of our defenses against this threat. to further improve the national public As a result, we are refining our approach to potential threats – vaccines - must for health system. These funds supported hiring protecting our population. the most part be given prophylactically 2001-2004: Serious national preparation and training of additional staff within state and there may be more behavorial and local public health agencies, planning A basic appreciation for the differences issues than technical because vaccines The events of 2001 prompted many new activities, improving physical infrastructure between “bio” and “chem” was a huge step carry their own, if minimal, risk; biodefense initiatives within the US, more – particularly information technologies, and forward. It led to our initial awareness of the outside the DoD than within. Following to develop a national network of Federal, central role of the public health bioterrorism Regulatory barriers to developing the ‘anthrax letters’ and the five deaths state, and local public health laboratories. preparedness and response. But, even with medical countermeasures are significant by resulting from inhalational anthrax, the that understanding, we continue to focus and cost and many of the products have US Government became serious about In March of ’03, the Department of on very specific medical countermeasures a relatively short shelf lives; preparation for a bioterrorist attack against Homeland Security (DHS) was formed to and relatively simple, but expensive, aerosol our population. USAMRIID, having prepared consolidate Federal anti-terrorism assets and sensors in cities to warn of attack. In the Specific intelligence regarding the threat to support forensic identification in the late programs — including several biodefense post-9/11 serge of biodefense activity and is extremely difficult and the real risk of ‘90s, processed more samples than any activities — within one department. funding, many government officials believed this low-likelihood but potentially very other laboratory immediately post October DoE’s laboratory programs, managed by technical muscle alone would provide high-impact event is almost impossible to 2001. DoD experts supported biological DHS, increased their role in non-medical sufficient protection. Now, we are realizing measure. defense programs in the Department of biological research and development while that more complex and more difficult Health and Human Services (DHHS) and the DHHS expanded its tech base medical counter-measures are needed. As the difficulty of the task sinks in, we the Department of Homeland Security programs, to include construction of high- are now considering solutions that are (DHS) as they scrambled to ramp up. containment laboratories regionally within In recent months, we have started to “step ‘broad spectrum’ in nature. Examples academic centers. At the same time, DoD’s to the side” to review and chart the way include research on non-specific immune The ’03 President’s budget specifically for medical and non-medical tech base budgets ahead. The core of the problem – biology modulators rather than very specific ‘one- biodefense soared to $5.8B. Of this amount, for biodefense remained relatively flat. - has several unique characteristics: bug’ vaccines and the involving citizen-
NEW DEFENCE AGENDA 59 teams in response rather than depending Randall S. Murch, Ph.D. crossovers between (human) public health, life sciences and technologies. The ability on emergency professionals alone. Both Virginia Polytechnic Institute and State animal and plant health and protection, and of the life sciences community to exploit of these approaches could move the University, Alexandria, Virginia USA food safety with security are obvious and this knowledge is extraordinary and is a population bell curve to the right: one have been addressed by numerous experts permanent feature of our common future. regarding its immune status and the other over the past several years. In keeping The diversity and magnitude of current and its behavioral response in a health crisis Though gaps and complexity exist between with the charge I have been given, I will future advancements in the life sciences following an incident or introduction of European and U.S. on biosecurity and address areas of collaboration in science may potentially provide considerable disease. Both are excellent proposals, but bioterrorism, I strongly suggest that and technology, but of course broader benefits to health and medicine, increase not quick or easy fixes. there are a number of areas for potential implications will be recognizable. the resiliency of the human population as cooperation and collaboration between the a whole, and make the use of infectious After an initial rush to technical solutions, two parties. I tend to think of problems and In this regard, concerted collaboration disease weapons increasingly obsolete by there is now more talk of the non-technical: challenges as “opportunities”. between the United States and Europe providing robust protections. Logically, building international understanding and within a productive, structured agenda can humanity wants to push ahead these entirely norms regarding the potential abuse of In my view, whatever we decide to do together produce “grand leaps” in the broader fight legitimate scientific activities in order to biotechnology, cooperation in deterrence in these areas should best be couched against infectious diseases: these enormous medical, agricultural, and and response, joint education and awareness under the broader rubric of addressing the environmental benefits. But, the same programs and integration of species-neutral challenges of current, emerging and new Understanding the basic biology of science and technology can be used for disease surveillance internationally. This infectious diseases against human, animal, infectious microorganisms and biotoxins: and contribute to malevolent purposes evolution in thinking about biodefense is plant and food targets. There are numerous Seeking deep knowledge of – namely the misuse of advancements in not occurring in the U.S. alone. A number of of opportunities for the United States and pathogenicity, host-pathogen the life sciences to improve on the use of nations have recognized the unique challenges Europe to work together now and into the interactions and host response; disease as a weapon. of the biological threat and the importance foreseeable future. Our common goal must Detecting, characterizing and modeling of an approach that significantly improves be to provide our citizens and visitors with the disease process; This forces us to face a “grand challenge:” cooperation and coordination between the best possible array of defenses against Monitoring disease emergence, spread how to ensure the benefits of advances in public health and medical, law enforcement infectious diseases and their expression and persistence; the life sciences while containing the potential and first responder communities at the local, as outbreaks, epidemics or pandemics Understanding biological diversity and misuse for these advances for malevolent state, federal and international levels. – regardless of their origin. its implication to disease; ends. The United States and Europe need to Protecting, reversing, mitigating and jointly tackle this complex matrix of the “dual We are learning several key lessons. The Joint pursuits should include focused recovering from exposure or disease; use” of the life sciences with commitment, problem of bioterrorism is continually changing initiatives in areas including policy Cleaning up and repopulating creativity, and persistence. In my view, and evolving, and is not amenable to simple development; research, development, contaminated environments; and Europe and the United States should begin technical solutions. Preparing specifically testing, and validation programs; common Attributing and reconstructing the a process of methodically working together for each agent or even each incident is too systems for knowledge management, causes, effects and sources of disease on the many dimensions of this problem expensive. The potential for abuse of biology technology transfer, and training; and outbreaks. set: scientific, technological, ethical, moral, will likely become greater in the future. joint planning and exercises. We should legal, political and policy to lead the global Finally, protecting our citizens without strong endeavor to make these initiatives as Scientists, policymakers, and the public are community into new constructs and concepts international cooperation in technical and scalable, maneuverable and transportable increasingly aware of the extraordinary for improving risk anticipation, preparedness, non-technical areas may be impossible. as possible. The interrelationships and speed and content of discoveries in the response and management.
NEW DEFENCE AGENDA 61 I also suggest that we begin this partnership for a variety of reasons, but they go only model that applies the capabilities of each and cultural systems to achieve the state of by identifying, agreeing upon, and validating so far in developing an agenda for joint community at the right time and measures operational capability we seek. specific areas of mutual concern through a action. We must begin to build a process across the continuum of incident anticipation methodical and rigorous approach at the whereby we can persistently work through through recovery. In working jointly, this In the end, the New Defence Agenda or tactical (focused, short-view) and strategic differences between the United States and model requires each of the four to work some other European entity must will step (broad, long-view) levels. This approach Europe, and achieve true collaboration and jointly between communities and across the forward and provide the European side of would enable us to identify and validate cooperation on those matters we agree. Atlantic. a trans-Atlantic bridge that links the United priorities, gaps, needs, challenges, and Systems analysis enables us to address three States and Europe in the development of opportunities. It would also provide the ability key questions: This process would lead us to the next defenses against infectious diseases and to place the results of our joint efforts in the area for collaboration and cooperation biological weapons. Global health, resiliency, appropriate operational context - against Where are we now? - achieving Full Readiness. Transatlantic preparedness, and biosecurity can only be likely, well founded, plausible scenarios - for Where do we need to be? “readiness” flows from our work, and achieved through global partnerships. analysis, planning and training purposes. In How are we going to get there, if we hopefully, successes in developing a system short, we have to design and implement a are able to? for Joint Crisis Response, Coordination “systems analysis” approach to developing and Management. This area needs a jointly Dr. Florin N. Paul and pursuing a range of joint initiatives to This approach will provide us with the developed and validated set of performance Deputy Surgeon General, improve our defenses against infectious means to pursue robust, adaptive, and standards in use on both sides of the Atlantic Medical Directorate disease. Such an approach would include: enduring systems solutions to complex and that guides efforts to build capabilities. Ministry of National Defence, Romania evolving challenges. Thoughtfully and carefully stating We cannot wait for a major or even provocative, penetrating questions or There are two specific areas where the catastrophic crisis before developing these Opportunities For Collaboration problems we both hold in high priority; United States and Europe can work to cross-discipline and trans-Atlantic linkages. & Sharing Of Experience On Methodically and rigorously analyzing “operationalize” mutual collaboration Working jointly, we need to be focused and Biodefence these questions, problems or scenarios and cooperation. First, we need a system innovative in developing and implementing from both the European and U.S. or mechanism for Joint Crisis Response, joint structures, methods, capabilities, Nothing is so frightening and terrifying like perspectives; Coordination, and Management for both pathways, tools and techniques to before terrorism and bioterrorism. They are the Identification and validation of shared natural disease outbreaks and intentional an event fact, not during or afterwards. biggest threats that we have to face in these priorities, gaps, needs and opportunities; releases of disease. We need to commit to A systems approach to planning and times. Conceptualizing and designing joint implementing shared human and technological preparation would be helpful in forcing us solutions sets; systems that will enable full and rapid to deal with complexities with which we It is not my intention to focus on the causes Developing strategies and plans to coordination and management of the crisis might not be able to otherwise realize, that generate the wide range of terrorist execute; and consequences incidents affecting both understand, or contend. It would also allow attacks. We are very well aware that our Measuring success and outcomes; and sides of the Atlantic. This system requires close us to reach true systems solutions rather tasks are to inform and to prepare our Investing in processes for capturing and communication and collaboration between than personal preferences or temporary community, to face and to respond properly sharing lessons learned. four key, interdependent communities: point solutions developed “on the fly.” It to the threat. public health, agriculture, law enforcement, would assist in the creation and validation Meetings and seminars such as NDA’s and intelligence. Our goal should be to of standards of performance that would All figures show us that a community itself Bioterrorism Reporting Group are helpful create a fully interoperable, organizational allow us to cut across our political, social, cannot react and respond efficiently in the
NEW DEFENCE AGENDA 63 case of a crisis or accident. We only need authorities or negotiations with the private countries to build a regional stockpile. cornerstones of an efficient, protective to remind ourselves of the picture of the sector of pharmaceutical companies. Countries that do not have enough funds and countermeasure-focused policy against earthquake in Turkey three years ago or the to establish their own stockpile may jointly biological terrorism and terrorism itself. tsunami in December 2004. The fear and There are many discussions on international organize a regional one. First of all a regional pressure that the SARS outbreak posed and regional cooperation in many fields. One stockpile must meet the requirements of all on the international community in 2003 of the most important fields, having indeed involved parties. is more or less the picture of what could a very long projection and very long term Frank Rapoport happen during a biological crisis. effects, is protection and countermeasures Issues that should be considered are: Christopher C. Bouquet for bioterrorism. Sometimes the subject is 44 Could somebody predict how a manmade avoided or kept as “confidential”. On other the host country; Scott Flukinger biological crisis following a bio–attack with occasions, developing countries request customs requirements and modified pathogens would develop? the transfer of technology from democratic transportation, focused on emergency and developed countries to build their own delivery, to avoid any delay; The Project Bioshield Act of 2004: From my perspective it is almost impossible. capabilities for detection and production of agreement on the stockpiled products, Lessons learned for Europe specific equipments, vaccines, drugs. In such regarding each nation’s medical Allow me to consider, from a practical point cases, leaving aside the economical aspects, and pharmaceutical regulations and Weeks after the 9-11 attacks in the U.S., a of view, that a terrorist attack is a crisis confidence in partner countries is essential. common agreements on this issue; still-unknown perpetrator mailed weapons- that occurs suddenly and unexpectedly, agreements and regulations about the grade anthrax to Congressional offices in like a technological or natural accident; this From my very personal perspective there purchasing and delivery of the products Washington, D.C., and to several media approach makes things a little bit smoother are two key elements in prevention and in emergency; outlets on the U.S. East Coast. Five people than a real attack and probably not so medical response to a bio-crisis: the early common consent on who coordinates died and seventeen others became gravely terrifying for ordinary people. We have to detection, ideally real time detection, and the activity; ill. The event exposed the inadequacy of keep in mind that panic and fear are the two stockpile of drugs and vaccines. agreement on financial matters (costs, America’s public health system to respond facts that dramatically change the behaviour reimbursements); to a man-made epidemic, particularly one of people. This is one of the terrorists’ main The early detection of an attack is an security and safety, maintenance and involving agents of such lethality as anthrax. aims, to disturb the very normal life and extremely complex process that requires renewal of the stockpile; As one expert testified to a Senate reaction of people and their community. not only high technology but also well cultural, linguistic, religious, legal and committee after the attacks, “We must This approach is suitable, especially for a educated and trained personnel, good other matters that may affect the understand that public health is now an biological attack that mimics the natural planning, appropriate funding and last but efficiency of such an attempt. essential aspect of national security.”45 outbreak. The difference is in the number not least, a real network in the area of Following the anthrax attacks, the of sick people at the beginning of the responsibility. Bearing in mind the experience that the USA government undertook intensive new event, and when the pathogen involved is has in the field of stockpiling, it would be 44 frank Rapoport is a Partner and Christopher C. Bouquet is of Counsel genetically modified, classical treatment The other field in which cooperation and very useful to develop projects for different in the Government Contracts Practice Group of McKenna Long & Al- dridge LLP. Scott Flukinger is a Senior Advisor in the Government Affairs and preventive measures are more or less partnership must be built is the stockpiling of regions of Europe in this respect. Practice Group of McKenna Long & Aldridge LLP. The authors grate- fully acknowledge the contributions of John M. Clerici, Esq. to Project inefficient. medicines, medical equipment, vaccines etc. BioShield and the biodefense industry. Mr. Clerici is a Partner in MLA’s Government Contracts Practice Group. In conclusion, there are no doubts 45 Terrorism Through the Mail: Protecting Postal Workers and the Public, United States Senate, joint hearing before the Comm. on Governmental This approach has other benefits, such The issue of stockpiling becomes more that collective efforts and regional Affairs and the Subcomm. on Int’l Security, Proliferation & Fed. Services, 107th Cong, (2001) (Testimony of Tara O’Toole, MD. ) available at http:// as better involvement of public health complex when there is a common will of and international cooperation are the govt-aff.senate.gov/103101otoole.htm (Last visited March 4, 2005)
NEW DEFENCE AGENDA 65 efforts to counter the bioterrorism threat. of drugs and other products needed to First, BioShield limits the use of the Special biodefense in the event of an actual terrorist Indeed, between 2001 and the end of 2004, protect Americans in the event of a bio- Reserve Fund to the purchase of drugs, attack.54 federally-funded civilian biodefense programs terrorist attack;49 biological products and medical devices in the U.S. totaled nearly US $14.5 billion.46 applicable to treating a limited range of BioShield is notable both for the uniqueness In Fiscal Year (“FY”) 2005 alone, America is 2. provides for “calls” for development of specific potential terror agents, including biological, of the challenge they attempt to address expected to spend approximately US $7.6 countermeasures that include a commitment chemical, nuclear and radiological agents. and for its ambitious scope. The initiative billion on biodefense programs.47 During his that the Secretary of HHS will recommend Second, the provisions of BioShield under created an opportunity for Congress, the 2003 State of the Union Address, President to the President funding of procurement which the government may commit legal community, agency program managers Bush first proposed that Congress enact upon first development of a countermeas- to recommend funding for successfully and the industry to apply innovations in legislation to stimulate the development ure that meets certain criteria;50 developed countermeasures provided only U.S. government contracts law practice of countermeasures to protect against a limited incentive to companies to enter to an entirely new sector. However, initial bioterrorism. In response to this call, the 3. authorizes the procurement of counter- the biodefense market. These provisions implementation of BioShield has raised Senate passed its version of The Project measures for the nation’s stockpile using merely indicate that in the future the some questions about the government’s BioShield Act of 2004 (“BioShield” or the the Special Reserve Fund;51 government may provide more assurances commitment to create this sector, “Act”) on May 19, 2004, and the House to industry of a market for countermeasures necessitating a new round of legislative likewise adopted the Senate’s bill on July 15, 4. provides that in the event of a national than government has provided in the past. initiative. The “lesson learned” for Europe 2004. The President signed the bill into law emergency, the government is authorized is: “get it right the first time”. Rather than on July 21, 2004. to make available new and promising treat- New biodefense legislation now under taking a piecemeal approach to promoting ments prior to approval by the Food and consideration by the 109th Congress the development of countermeasures to The Act has an ambitious policy goal: Drug Administration (“FDA”);52 and, finally, seeks to address these industry concerns. bioterrorism, Europe should act boldly. to create a new biodefense industry to This legislation would broaden the expeditiously develop and produce medical 5. provides for streamlined and simplified ac- definition of countermeasures that may countermeasures and related products quisition procedures for the procurement be procured with the Special Reserve and services to secure the U.S. homeland of countermeasures for select bioterror Fund to include detection technology, against bioterrorism. Specifically, the Act agents, like smallpox, anthrax and plague.53 diagnostics and research tools. In addition, amends the Public Health Service Act48 to the countermeasures may also be used create five tools for promoting commercial While BioShield was an important step in to counter public health threats posed involvement in biodefense: the creation of a new biodefense industry, by naturally occurring infectious disease, industry reaction to the Act has been such as the pandemic flu. Moreover, the 1. it provides the Secretary of the Depart- muted, partly because the government has legislation under discussion would provide ment of Health and Human Services not taken full advantage of its new legal powerful tax and patent incentives to (“HHS”) with streamlined authorities to authorities and partly because the scope companies seeking to enter the biodefense promote the research and development and incentives of BioShield are somewhat industry. Finally, the legislation would also limited. Bioshield is limited in two respects. offer liability protections to the biodefense 46 Ari Schuler, Billions for Biodefense: Federal Agency Biodefense Funding, FY2001- industry. This issue was not addressed in FY2005, Vol. 2, No. 2, Biosecurity and Bioterrorism: Biodefense Strategy, 49 See Id. § 319F-1. Practice, and Science, p.86 (2004) [hereinafter, Schuler] See, http://www. 50 See Id. § 319F-2(c)(4). liebertonline.com/doi/pdf/10.1089/153871304323146388 (Last visited the BioShield debates and, currently, federal March 4, 2005) 51 See Id. § 319F-2(c)(7). law only provides limited protections 47 Id. 52 21 U.S.C. § 360bbb-3. 54 Publ. Law No. 107-296, § 862. 48 42 U.S.C. § 243 et. seq. 53 42 U.S.C. § 319F-2 for developers of countermeasures for
NEW DEFENCE AGENDA 67 Future programmes of the NDA C4I: What advantage does integrated intelligence policy and technology procurement in Bioterrorism Reporting Group today’s market have on interdicting bio-terrorism or bio-warfare? As the European Union continues to strengthen its security and defence position, intelligence capability plays a critical role in defending against WMD and more specifically biological weapons October 2005 diversion, acquisition and procurement by terrorists and states. Changes in European operational Critical Infrastructure Protection and Intelligence: and strategic initiatives such as post-war engagement in Iraq and Afghanistan will necessitate the need for an increased and consolidated intelligence capability. The seeming failure of the US Is European bioterrorism preparedness up to par? intelligence community to accurately assess Iraq’s biological weapons programmes highlights the increasing need for Europe to increase and integrate its intelligence capabilities to independently Are national governments ready to defend critical infrastructure and is a European level assess the threat of biological terrorism. Europe’s lagging investment in procurement leave it approach necessary? vulnerable for sensitive tasking and operational engagement of forces, what must be done now to prepare for fourth generation warfare and asymmetric bio-terrorism? How can the EU develop Collecting and sharing data that provide an understanding of the operating status of critical the technical and skill base to ensure European security both within the EU and abroad? infrastructure, key assets, and major events will allow for the detection of anomalous changes in operations and activities. Evaluating critical infrastructure protection provides an understanding What role should European C4I capabilities play in preventing and detecting potential of potential targets of terrorist activities to allow better interpretation of data that may point to acts of bio-terrorism or warfare? terrorist targeting of critical infrastructure, key assets, and major events. Is a net centric approach to critical infrastructure protection viable during a deliberate disease outbreak? Do we need to Civilian verses Military Intelligence tasking is there common ground for bio-defence? streamline the current data sharing systems to better track criminals and terrorists who may divert or acquire Category A biological warfare agents? The session looks at SIS Plus and its limitations. Identification of challenges facing the European C4I industry; Which areas are the most crucial and the most vulnerable during a biological attack? How has preparing for net-centric warfare altered the European C4I markets and what Civil military approaches to the threat of catastrophic unconventional weapons: what effect is this likely to have on bio-defence? interactions and deviations?
Which states pose the greatest threat for unconventional weapons deployment and how can we defend against this? January/February 2006 The Biological and Toxin Weapons Convention at Are EU policies in place to prevent critical infrastructure failure? a Crossroads: Principles, Policy and the Future of How do we target and prevent states from sponsoring unconventional weapons? Enforcement
Are there losses in integration? The BTWC was the first disarmament treaty to ban an entire class of weapons in both peacetime and during the engagement of war. This meeting will address Verification (Past, What policies do we need to ensure infrastructure protection during a major bio-terror event? Present and Future), and outline critical issues on the 2006 agenda. Heads of European delegations to the Convention will be invited to attend. Rapid advancements in the life How well integrated are our resources and capabilities? sciences merit caution over novel security threats which might arise from biological
NEW DEFENCE AGENDA 69 research, how openly should results be communicated? Are some basic research projects About the New Defence Agenda (NDA) too ‘contentious’ to pursue? NDA will debate the principles, practicality and potential for implementation of a universal code of conduct and make recommendations to all key stakeholders. At the suggestion of NATO’s Jamie Shea, Deputy Assistant Secretary General for Bioterrorism and to a wider extent CBRN terrorism also involves a number of other essential External Relations, Public Diplomacy communities: public health, science, academia, industry, organizations and security agencies. Division, Forum Europe established the Given the national security and non-proliferation regimes which are often in conflict, which New Defence Agenda in early 2002 to institutions are better placed to make hard-line calls and develop security policy? Is the provide a common meeting ground for NGO community, not having access to intelligence information, capable of making informed defence and security specialists from ‘decisions’ on bio-defence? Are there appropriate mechanisms for essential exchanges of NATO and the EU that would meet on a information? Who should set security policy on biological and unconventional weapons regular basis. regimes? Is there a problem with governmental transparency? Is the non-proliferation agenda and arms control defined by national players or NGOs? Now the only Brussels-based platform for debate devoted solely to defence and security issues, NDA’s International Conferences, Press Dinners and Monthly Roundtables bring top EU and NATO officials together with senior figures from governments, defence industries, the military, April 2006 academia and press. The NDA also serves as a networking centre of defence-related think tanks WARGAME scenario: BLUE MERCURY and experts around Europe.
The NDA is developing a table top war game exercise for the European Communities. The aim of the NDA is not to replicate more academic research-based projects but to give greater Blue Mercury will highlight the impact of unconventional weapons proliferation and the prominence to the complex questions of how the EU and NATO policies can complement one likely effect of a bio-terrorist attack on the European Community. A biological agent another, and to stimulate reaction within the international press. located in an unstable region outside Europe has been transferred into Europe by plane and European leaders are faced with coordinating responses to an outbreak within the EU One of our prime objectives is to raise the profile of defence and security issues among the while contributing to a more global effort to resolve the arisen crisis abroad. Brussels-based international press. To encourage more in-depth coverage of these topics, the NDA holds regular, informal dinners for journalists. Drawing on NDA’s pool of experts in the field, it is anticipated high-level officials will play the part of national leaders. The game is designed to emphasize the European role in The NDA’s Advisory Board is made of some 20 prominent defence experts drawn from a cross- prevention and response to unconventional weapons use and to gain wider understanding section of government, politics and industry and is patroned by Jaap de Hoop Scheffer, Javier of the need to strengthen the prohibition against the use of disease as a weapon of mass Solana, Benita Ferrero-Waldner and Franco Frattini. destruction by state parties. This scenario would be positioned as a day-long event.
NEW DEFENCE AGENDA 71 The CBACI Commitment The New Defence Agenda would like to
Since 1993, the Chemical and Biological Arms Control Institute (CBACI) has worked to thank its partners and members for their address 21st century security challenges, with a special but not exclusive focus on the elimination of chemical and biological weapons. A nonprofit, private policy research support in making the NDA a success organization, CBACI fosters its mission through an innovative program of research, analysis, technical support, and education. Within its global network of policy makers in government, industry, the scientific community, the media, and other critical constituencies, CBACI provides a unique strategic perspective and effective policy options on contemporary security challenges Ahead of its time…CBACI has Identified chemical and biological terrorism as an emerging threat – even before the attack in the Tokyo subway in 1995 Sponsored the first major conference on CBW terrorism in Washington Launched its Health and Security Program well before HIV/AIDS was identified as a national security challenge
Leading-edge…CBACI has Conducted one of the first studies of U.S. preparedness for a domestic bio-terrorist attack based on an innovative threat assessment methodology and requirements based analysis Promoted a new “intellectual infrastructure” to address the biological challenge, including novel conceptual building blocks and analytical tools Advocated new partnerships among critical constituencies, not least of which is the sustained engagement of the life sciences industries in addressing emerging challenges
Global in scope and operation…CBACI has Created a 27-member International Research Advisory Council with experts from around the world Sponsored or participated in activities in more than two dozen countries, including Australia, Belgium, Canada, Germany, Hungary, Israel, Japan, Kuwait, Malaysia, and Singapore.
Chemical and Biological Arms Control Institute 1747 Pennsylvania Avenue, NW, 7th Floor Turkish MoD Romanian MoD Russian Mission to the EU Washington, DC 20006 Phone: (202) 296-3550 Fax: (202) 296-3574 Web: www.cbaci.org E-mail: [email protected]
Interested in joining the NDA? Please contact Linda Karvinen Tel:+32 (0)2 737 9148 Fax: +32 (0)2 736 32 16 E-mail: [email protected] Following the interest generated in past NDA events and the encouragement of their participants, the NDA decided to create a venue for more focused discussions on the area of bioterrorism. The Bioterrorism Reporting Group will allow the discussions not only to be tailored to the evolving developments in the biological field but most of all, the resulting report will act as a catalyst for the political world.
There is no question of the need for policies directly focused against the use of biological agents as weapons. The use of disease as a weapon of mass destruction (WMD) is considered a low probability, high consequence event. However, if such an event were to occur, the consequences would be so severe that preparatory action must be undertaken to prevent it. Although biological weapons are often grouped together as agents of mass destruction, biological weapons vary significantly from chemical and nuclear munitions. Biological weapons and materials have the capacity to silently infect thousands of people, destroy agriculture and infect animal populations.
Of all the classes of WMDs, biological weapons remain the most vulnerable to diversion while also being the most difficult to detect.U nlike the Chemical Weapons Convention and the nuclear Non-Proliferation Treaty, which have full verification regimes, the Biological and ToxinW eapons Convention does not. This leaves the development and potential use of bio-agents entirely unchecked. It is therefore imperative governments begin to address the serious threat biological terrorism poses to the EU and the international community.
NEW DEFENCE AGENDA Forum Europe Tel: +32 (0)2 737 91 48 Bibliothèque Solvay Fax: +32 (0)2 736 32 16 137 rue Belliard [email protected] B-1040, Brussels, Belgium www.newdefenceagenda.org