Report

October 2015

A National Blueprint for Biodefense:

Leadership and Major Reform Needed to Optimize Efforts

NOTE: The Blue Ribbon Study Panel on Biodefense is now the BIPARTISAN COMMISSION ON BIODEFENSE

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Commissioners
Ex Officio Members
Commission Staff
Preface
Executive Summary
Scenario

Introduction: The Challenge of Leadership

I. The Biological Threat is Real and Growing: The Challenge of Leadership
II. Previous Commissions Have Expressed Concern
III. The United States Lacks Centralized Biodefense Leadership

Chapter 1: The Need For Leadership in Achieving Coordination

I. The Imperative for Cogent Governance
II. Improving Intelligence Community Efforts
III. Recognizing and Institutionalizing the One Health Concept
IV. Coordinating Medical Countermeasure Efforts
V. Establishing an Attribution Apparatus
VI. Taking Charge of Decontamination and Remediation

Chapter 2: The Need for Leadership in Elevating Collaboration

I. Achieving an Integrated Biosurveillance and Biodetection Capability
II. Supporting Emergency Preparedness
III. Creating Incentives for Hospital Preparedness
IV. Advancing Planning for Medical Countermeasure Distribution and Dispensing
V. Dealing with Cyber Threats to Pathogen Security
VI. Reengaging with the Biological and Toxin Weapons Convention
VII. Building upon Defense Support to Civil Authorities

Chapter 3: The Need for Leadership in Driving Innovation

I. Incentivizing Civilian Medical Countermeasure Development
II. Leaping Ahead to a Modern State of Biodetection
III. Removing Select Agent Program Impediments to Innovation
IV. Implementing Novel Approaches to Global Health Response

Appendix A: Proposed Congressional Oversight Hearings
Appendix B: Methodology
Appendix C: Meeting Agendas and Speakers
Appendix D: Acronyms
Appendix E: Financial Sponsors
Acknowledgments
Endnotes

Commissioners

Joseph I. Lieberman, Chair
Thomas J. Ridge, Chair
Donna E. Shalala
Thomas A. Daschle
James C. Greenwood
Kenneth L. Wainstein

Ex Officio Members

Yonah Alexander, PhD
William B. Karesh, DVM
Rachel Levinson, MA
I. Lewis Libby, JD
Gerald W. Parker, DVM, PhD
George Poste, DVM, PhD, DSc
Tevi Troy, PhD

Commission Staff

Ellen P. Carlin, D.V.M., Co-Director
Asha M. George, Dr.P.H., Co-Director
Patricia de la Sota, Staff Assistant
Stephanie Marks, J.D., Intern

Founding Staff Director

Robert B. Kadlec, M.D.

Preface

October 28, 2015

To the President, Congress, and the American People:

The United States is underprepared for biological threats. Nation states and unaffiliated terrorists (via biological terrorism) and nature itself (via emerging and reemerging infectious diseases) threaten us. While biological events may be inevitable, their level of impact on our country is not.

We convened the Bipartisan Commission on Biodefense to assess how much has been done to address the biological threat and what remains undone. Despite significant progress on several fronts, the Nation is dangerously vulnerable to a biological event. The root cause of this continuing vulnerability is the lack of strong centralized leadership at the highest level of government.

Crisis after biological crisis has forced the United States to act. Naturally occurring threats such as influenza, Ebola, and Chikungunya are bypassing borders to emerge in nations oceans away, and exact a continued toll. The Islamic State of Iraq and the Levant (also known as ISIL and Da’esh) is devastating the Middle East while espousing the value of biological weapons for their ability to cause massive loss of life. The U.S. government has mishandled extremely dangerous viruses and bacteria in some of its highest level laboratories. The Nation lacks the leadership, coordination, collaboration, and innovation necessary to respond.

This Commission (through public meetings, targeted interviews, and extensive research) examined the national state of defense against biological attacks and emerging and reemerging infectious diseases, of the order that could cause catastrophic loss of life, societal disruption, and loss of confidence in our government. We scrutinized the status of prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation – the spectrum of activities deemed necessary for biodefense by both Republican and Democratic Administrations, and many experts outside of government. We identified substantial achievements, but we also found serious gaps and inadequacies that continue to leave the Nation vulnerable to threats from nature and terrorists alike.

Successive Presidents, beginning with William J. Clinton and followed by George W. Bush and Barack H. Obama, enacted policies intended to strengthen national biodefense. As a result, many federal departments and agencies took action and the majority of these programs received bipartisan congressional support. Yet fourteen years after the last report of the U.S. Commission on National Security/21st Century, eleven years after the report of the National Commission on Terrorist Attacks upon the United States, ten years after the report of the Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction, and seven years since the report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, the insufficiency of our myriad and fragmented biodefense activities persists because biodefense lacks focused leadership. Capable individuals oversee elements at the department and agency levels, but no steward guides them collectively.

As leaders in past Administrations and Congresses, we, the members of the Commission, had a role in our national biodefense and we share responsibility for its shortcomings. Our intent is to help remedy the correctable shortfalls by identifying specific short-, medium-, and long-term programmatic, legislative, and policy actions in this report. We urge those in leadership positions to implement our recommendations with utmost haste. Lives are in the balance.

We provided this charge to ourselves – without a commission from Congress or the President – and tried not to duplicate the work of previously mandated commissions and appointed panels. Instead, we built on and contemporized their insights, observations, and recommendations. While we originally intended to assess both biological and chemical threats, we came to believe that the more immediate concern regarding loss of life is the biological threat and that in focusing on it, there will be collateral benefits for dealing with the chemical threat as well.

Biodefense touches many aspects of society, falling within the purview of national security, homeland security, public health security, and economic security. As such, it requires an enterprise approach – eliminating stovepipes; transcending agency-centric activity; drawing upon stakeholders throughout government, academia, and the private sector; and recognizing the extraordinary breadth of the challenge – to provide flexible solutions that address the full spectrum of the threat. Most importantly, the Nation needs an overarching leader who recognizes the severity of the biological threat and possesses the authority and political will to defend against it. This top-level leader, together with leaders throughout the enterprise, must guide efforts and ensure that the combined impact of biological threats, vulnerabilities, and consequences are managed using a common biodefense strategy.

As former Secretary of the Navy Richard Danzig told us, “We don’t really get to choose what we have to prepare for.” We have no choice – the Nation must take action to defend against the biological threat. We have done much already, but we need the leadership only a top-level official can bring to bear to optimize the biodefense enterprise. We believe that our recommendations will make America more secure, and we will continue to monitor actions taken to improve our national biodefense posture. If you take and demand action now, you can save lives. There is no greater calling or responsibility.

Joseph I. Lieberman
CHAIR

Thomas J. Ridge
CHAIR

Executive Summary

Background

The Bipartisan Commission on Biodefense was established in 2014 to assess gaps and provide recommendations to improve U.S. biodefense. The Commission – supported by a suite of distinguished ex officio members and staff with deep expertise in science, policy, intelligence, and defense; institutional hosting through Hudson Institute and the Inter-University Center for Terrorism Studies at Potomac Institute for Policy Studies; and funds from academia, foundations, and industry – determined where the United States is falling short of addressing biological attacks and emerging and reemerging infectious diseases.

Individuals from all levels of government, industry, academia, and advocacy provided their perspectives at a series of four day-long meetings with the Commission. They addressed the pillars of biodefense outlined in Homeland Security Presidential Directive (HSPD) 10:

Report Organization

The Nation has made some progress with biodefense and this report does not dismiss this. Rather than catalog success, however, this report delineates areas needing improvement and provides key recommendations to address them. Although challenges undoubtedly exist in all of the capability areas needed for biodefense, this report describes that subset brought to the Commission’s attention as being the most problematic. It also pushes beyond the limits of HSPD-10 to urge greater inclusion of issues like animal health and global engagement as key components of the biodefense mission. This report contains proposals for an effective leadership construct and a renewed governance structure. It provides a detailed blueprint for reform with action items that are categorized by time to completion (summarized in Table 1): short-term (in one year or less); medium-term (within one to three years); and long-term (within three to five years).

The Challenge of Leadership

Simply put, the Nation does not afford the biological threat the same level of attention as it does other threats: There is no centralized leader for biodefense. There is no comprehensive national strategic plan for biodefense. There is no all-inclusive dedicated budget for biodefense.

The Nation lacks a single leader to control, prioritize, coordinate, and hold agencies accountable for working toward common national biodefense. This weakness precludes sufficient defense against biological threats. A leader must, therefore, take charge of our Nation’s response to biological crises, as well as day-to-day activities in the absence of such crises.

Leadership of biodefense should be institutionalized at the White House with the Vice President. This office alone can be imbued with the authority of the President to coordinate agencies, budgets, and strategies across the government in a way that no other position can.

The Need for Leadership to Achieve Coordination and Accountability

Inter-governmental and multi-disciplinary efforts are needed to adequately defend the Nation against biological threats. Centralized, effective leadership is necessary to direct and harmonize these efforts, but because this is lacking, biodefense activities are insufficiently coordinated. This problem can largely be resolved through the leadership of the Vice President and the establishment of a White House Biodefense Coordination Council.

The coordination problem is exacerbated by the lack of a comprehensive biodefense strategy and a unified approach to budgeting, both vital to any strategic interagency effort. Congressional oversight efforts are hampered by the lack of these important components, insufficient awareness of the threat, and inadequate oversight among committees. These challenges could be alleviated in part through regular and in-depth intelligence briefings for Members of Congress, and implementation of joint congressional oversight agendas.

The lack of coordination at the highest levels impacts a variety of downstream areas of critical importance, including: intelligence activities; full consideration of the interrelationships among animal, environmental, and human health; coordination of MCM development; attribution of bioterrorist acts; and environmental decontamination and remediation. These critical areas demand better integration and clear prioritization, aligned with funding and investment, in order to inform stakeholders across the biodefense spectrum and enable them to execute a strategy once it is developed.

The Need for Leadership to Elevate Collaboration

U.S. biodefense is not, nor should it be, a solely federal function. The impact of biological events, while felt nationally, will be addressed locally. The federal government must aid in strengthening state, local, territorial, and tribal biodefense capabilities and increase the support and access provided to them far beyond current levels.

Rapid and accurate identification of a pathogen moving through humans, animals, or the environment is absolutely necessary, yet significant advances in such identification remain elusive. The federal government must implement a nationally integrated biosurveillance capability, dramatically improve environmental biosurveillance, and substantially augment collection and incorporation of animal data into human biosurveillance systems.

The Nation must also demonstrate support for emergency services through improved training, enhanced personal protection, and better intelligence sharing. We must commit reasonable viii and sustained levels of financial support to state, local, territorial, and tribal health departments. The federal government must also increase support to hospitals, through tighter management of Hospital Preparedness Program funds, development of Centers for Medicare and Medicaid Services incentives, and accreditation of select hospitals as biodefense specialty centers.

Public-private partnerships are fundamental to any efforts toward development, distribution, and dispensing of MCM. We must produce a MCM response framework that is predicated on non-federal input, collaboration, and implementation, and that allows for pre-deployment of stockpiles. Finally, the federal government must lead efforts to secure vulnerable pathogen data.

The Need for Leadership to Drive Innovation

The innovative process of scientific discovery is inherently fraught with uncertainty. Yet biodefense efforts urgently call for a much greater focus on innovation than ever before – because biological threats are imminent, biological vulnerabilities have existed for too long, and the complexity of the threat requires equally complex solutions. Biodefense also requires sustained prioritization and funding to ensure that success realized thus far is maintained, and that opportunity and innovation are pursued.

We must revolutionize the development of MCM for emerging infectious diseases, fully fund and incentivize the MCM enterprise, and remove bureaucratic hurdles to MCM innovation. We must develop a system for environmental detection that leverages the ingenuity of industry and meets the growing threat. We must overhaul the Select Agent Program to enable a secure system that simultaneously encourages participation by the scientific community. Finally, we must help lead the international community toward the establishment of a fully functional and agile global public health response apparatus.

Conclusions

We have reached a critical mass of biological crises. Myriad biological threats, vulnerabilities, and consequences have collectively and dramatically increased the risk to the Nation. They have also, we believe, garnered the attention of enough people who understand the threat is real, want to mobilize and take action, and can provide for effective national biodefense.

Leadership moves America forward. A central and authoritative leader – who, by recommendation of this report, is the Vice President – can foster substantial progress in biodefense. Once installed as this leader, the Vice President (and the interagency team of experts who will work to realize the strategic vision of the Executive and Legislative Branches) can also foster substantial progress, much of it in the near term. This is especially true for coordinating federal activities, forging intersectoral partnerships, and revolutionizing the ways in which we approach this mission space.

Dramatic improvements are within our reach if we follow a national blueprint for biodefense, establish leadership, and engage in major reform efforts that build on the good work that is already in place.