    [Public Papers of the Presidents of the United States: George W. Bush (2007, Book I)]
    [January 31, 2007]
    [Pages 109-115]
    [From the U.S. Government Publishing Office www.gpo.gov]

    Homeland Security Presidential Directive/HSPD-18--Medical
    Countermeasures Against Weapons of Mass Destruction
    January 31, 2007

    Subject: Medical Countermeasures against Weapons of Mass Destruction

    BACKGROUND

        (1) Weapons of Mass Destruction (WMD)--chemical, biological,
    radiological, and nuclear agents (CBRN)--in the possession of hostile
    states or terrorists represent one of the greatest security challenges
    facing the United States. An attack utilizing WMD potentially could
    cause mass casualties, compromise critical infrastructure, adversely
    affect our economy, and inflict social and psychological damage that
    could negatively affect the American way of life.
        (2) Our National Strategy to Combat Weapons of Mass Destruction
    (December 2002) and Biodefense for the 21st Century (April 2004)
    identify response and recovery as key components of our Nation's ability
    to manage the consequences of a WMD attack. Our primary goal is to
    prevent such an attack, but we must be fully prepared to respond to and
    recover from an attack if one occurs. Accordingly, we have made
    significant investments in our WMD consequence management capabilities
    in order to mitigate impacts to the public's health, the economy, and
    our critical infrastructure. The development and acquisition of
    effective medical countermeasures to mitigate illness, suffering, and
    death resulting from CBRN agents is central to our consequence
    management efforts.
        (3) It is not presently feasible to develop and stockpile medical
    countermeasures against every possible threat. The development of
    vaccines and drugs to prevent or mitigate adverse health effects caused
    by exposure to biological agents, chemicals, or radiation is a time-
    consuming and costly process. This directive builds upon the vision and
    objectives articulated in our National Strategy to Combat Weapons of
    Mass Destruction and Biodefense for the 21st Century to ensure that our
    Nation's medical countermeasure research, development, and acquisition
    efforts:

        (a) Target threats that have potential for catastrophic impact on
    our public health and are subject to medical mitigation;

        (b) Yield a rapidly deployable and flexible capability to address
    both existing and evolving threats;

        (c) Are part of an integrated WMD consequence management approach
    informed by current risk assessments of threats, vulnerabilities, and
    capabilities; and

        (d) Include the development of effective, feasible, and pragmatic
    concepts of operation for responding to and recovering from an attack.

        (4) In order to address the challenges presented by the diverse CBRN
    threat spectrum, optimize the investments necessary for medical
    countermeasures development, and ensure that our activities
    significantly enhance our domestic and international response and
    recovery capabilities, our decisions as to the research, development,
    and acquisition of medical countermeasures will be guided by three
    overarching principles:

        (a) Our preparations will focus on countering current and
    anticipated threat agents that have the greatest potential for use by
    state and non-state actors to cause catastrophic public health
    consequences to the American people.

        (b) We will invest in medical countermeasures and public health
    interventions that have the greatest potential to prevent, treat, and
    mitigate the consequences of WMD threats.

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        (c) We will link acquisition of medical countermeasures to the
    existence of effective deployment strategies that are supportable by the
    present and foreseeable operational and logistic capabilities of
    Federal, State, and local assets following a WMD attack or other event
    that presents a catastrophic public health impact.
        (5) Mitigating illness and preventing death are the principal goals
    of our medical countermeasure efforts. As a class, biological agents
    offer the greatest opportunity for such medical mitigation, and this
    directive prioritizes our countermeasure efforts accordingly. This
    directive also provides for tailoring our Nation's ongoing research and
    acquisition efforts to continue to yield new countermeasures against
    CBRN agents and for incorporating such new discoveries into our domestic
    and international response and recovery planning efforts.

    Biological Threats

        (6) The biological threat spectrum can be framed in four distinct
    categories, each of which presents unique challenges and significant
    opportunities for developing medical countermeasures:
        (a) Traditional Agents: Traditional agents are naturally occurring
    microorganisms or toxin products with the potential to be disseminated
    to cause mass casualties. Examples of traditional agents include
    Bacillus anthracis (anthrax) and Yersinia pestis (plague).
        (b) Enhanced Agents: Enhanced agents are traditional agents that
    have been modified or selected to enhance their ability to harm human
    populations or circumvent current countermeasures, such as a bacterium
    that has been modified to resist antibiotic treatment.
        (c) Emerging Agents: Emerging agents are previously unrecognized
    pathogens that might be naturally occurring and present a serious risk
    to human populations, such as the virus responsible for Severe Acute
    Respiratory Syndrome (SARS). Tools to detect and treat these agents
    might not exist or might not be widely available.
        (d) Advanced Agents: Advanced agents are novel pathogens or other
    materials of biological nature that have been artificially engineered in
    the laboratory to bypass traditional countermeasures or produce a more
    severe or otherwise enhanced spectrum of disease.

    Nuclear and Radiological Threats

        (7) Threats posed by fissile and other radiological material will
    persist. Our Nation must improve its biodosimetry capabilities and
    continue to develop medical countermeasures as appropriate to mitigate
    the health effects of radiation exposure from the following threats:
        (a) Improvised Nuclear Devices: Improvised nuclear devices
    incorporate radioactive materials designed to result in the formation of
    a nuclear-yield reaction. Such devices can be wholly fabricated or can
    be created by modifying a nuclear weapon.
        (b) Radiological Dispersal Devices: Radiological Dispersal Devices
    (RDDs) are devices, other than a nuclear explosive device, designed to
    disseminate radioactive material to cause destruction, damage, or
    injury.
        (c) Intentional Damage or Destruction of a Nuclear Power Plant:
    Deliberate acts that cause damage to a reactor core and destruction of
    the containment facility of a nuclear reactor could contaminate a wide
    geographic area with radioactive material.

    Chemical Threats

        (8) Existing and new types of chemicals present a range of threats.
    Development of targeted medical countermeasures might be warranted for
    materials in the following categories:
        (a) Toxic Industrial Materials and Chemicals: Toxic Industrial
    Materials and Chemicals are toxic substances in solid, liquid, or
    gaseous form that are used or stored for use for military or commercial
    purposes.

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        (b) Traditional Chemical Warfare Agents: Traditional chemical
    warfare agents encompass the range of blood, blister, choking, and nerve
    agents historically developed for warfighter use.
        (c) Non-traditional Agents: Non-traditional agents (NTAs) are novel
    chemical threat agents or toxicants requiring adapted countermeasures.
        (9) Creating defenses against a finite number of known or
    anticipated agents is a sound approach for mitigating the most
    catastrophic CBRN threats; however, we also must simultaneously employ a
    broad-spectrum ``flexible'' approach to address other current and future
    threats. We must be capable of responding to a wide variety of potential
    challenges, including a novel biological agent that is highly
    communicable, associated with a high rate of morbidity or mortality, and
    without known countermeasure at the time of its discovery. Although
    significant technological, organizational, and procedural challenges
    will have to be overcome, such a balanced strategic approach would
    mitigate current and future CBRN threats and benefit public health.

    POLICY

        (10) It is the policy of the United States to draw upon the
    considerable potential of the scientific community in the public and
    private sectors to address our medical countermeasure requirements
    relating to CBRN threats. Our Nation will use a two-tiered approach for
    development and acquisition of medical countermeasures, which will
    balance the immediate need to provide a capability to mitigate the most
    catastrophic of the current CBRN threats with long-term requirements to
    develop more flexible, broader spectrum countermeasures to address
    future threats. Our approach also will support regulatory decisions and
    will permit us to address the broadest range of current and future CBRN
    threats.

    Tier I: Focused Development of Agent-Specific Medical Countermeasures

        (11) The first tier uses existing, proven approaches for developing
    medical countermeasures to address challenges posed by select current
    and anticipated threats, such as traditional CBRN agents. Recognizing
    that as threats change our countermeasures might become less effective,
    we will invest in an integrated and multi-layered defense. Department-
    level strategies and implementation plans will reflect the following
    three guiding principles and objectives:
        (a) Evaluate and clearly define investments in near- and mid-term
    defenses: We will develop and use risk assessment processes that
    integrate data and threat assessments from the life science, consequence
    management, public health, law enforcement, and intelligence communities
    to guide investment priorities for current and anticipated threats. We
    will openly identify the high-risk threats that hold potential for
    catastrophic consequences to civilian populations and warrant
    development of targeted countermeasures.
        (b) Target medical countermeasure strategies to satisfy practical
    operational requirements: We will model the potential impact of high-
    risk threats and develop scenario-based concepts of operations for
    medical consequence management and public health mitigation and
    treatment of a large-scale attack on our population. These concepts of
    operations will guide complementary decisions regarding medical
    countermeasure development and acquisition.
        (c) Take advantage of opportunities to buttress U.S. defenses: We
    will coordinate interagency efforts to identify and evaluate
    vulnerabilities in our current arsenal of countermeasures to protect the
    U.S. population. Where appropriate, we will target the development of
    alternate or supplementary medical countermeasures to ensure that a
    multi-layered defense against the most significant high-impact CBRN
    threats is established.

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    Tier II: Development of a Flexible Capability for New Medical
    Countermeasures

        (12) Second tier activities will emphasize the need to capitalize
    upon the development of emerging and future technologies that will
    enhance our ability to respond flexibly to anticipated, emerging, and
    future CBRN threats. Importantly, this end-state will foster innovations
    in medical technologies that will provide broad public health benefit.
    Department-level strategic and implementation plans will reflect the
    following guiding principles and objectives:
        (a) Integrate fundamental discovery and medical development to
    realize novel medical countermeasure capabilities: We will target some
    investments to support the development of broad spectrum approaches to
    surveillance, diagnostics, prophylactics, and therapeutics that utilize
    platform technologies. This will require targeted, balanced, and
    sustained investments between fundamental research to discover new
    technologies and applied research for technology development to deliver
    new medical capabilities and countermeasures. Although by no means all-
    inclusive, our goals could include identification and use of early
    markers for exposure, greater understanding of host responses to target
    therapeutics, and development of integrated technologies for rapid
    production of new countermeasures.
        (b) Establish a favorable environment for evaluating new approaches:
    We must ensure that our investments lead to products that expand the
    scientific data base, increase the efficiency with which safety and
    efficacy can be evaluated, and improve the rate at which products under
    Investigational New Drug or Investigational Device Exemption status
    progress through the regulatory or approval process. In addition, we
    must continue to use new tools to evaluate and utilize promising
    candidates in a time of crisis. Examples of such tools include the
    ``Animal Rule'' for testing the efficacy of medical countermeasures
    against threat agents when human trials are not ethically feasible and
    the Emergency Use Authorization. Although by no means all-inclusive, our
    desired end-state could include the use of novel approaches for improved
    evaluation tools, streamlined clinical trials that meet safety and
    regulatory needs, and the development and use of novel approaches to
    manufacturing.
        (c) Integrate the products of new and traditional approaches: We
    must address the challenges that will arise from integrating these new
    approaches with existing processes. We must incorporate the use of non-
    pharmacological interventions in our response planning. This integration
    will forge a flexible biodefense capability that aligns our national
    requirements for medical countermeasures with the concepts of operation
    that are used in conjunction with other strategies for mitigating the
    public health impacts of WMD attacks.
        (13) In order to achieve our Tier I and II objectives, it will be
    necessary to facilitate the development of products and technologies
    that show promise but are not yet eligible for procurement through
    BioShield or the Strategic National Stockpile. We will support the
    advanced development of these products through targeted investments
    across a broad portfolio, with the understanding that some of these
    products may be deemed unsuitable for further investment as additional
    data becomes available, but the expectation that others will become
    candidates for procurement.

    POLICY ACTIONS

        (14) We will employ an integrated approach to WMD medical
    countermeasure development that draws upon the expertise of the public
    health, life science, defense, homeland security, intelligence, first
    responder, and law enforcement communities, as well as the private
    sector, to promote a seamless integration throughout the product
    development life cycle.

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        (a) The Secretary of Health and Human Services (Secretary) will lead
    Federal Government efforts to research, develop, evaluate, and acquire
    public health emergency medical countermeasures to prevent or mitigate
    the health effects of CBRN threats facing the U.S. civilian population.
    The Department of Health and Human Services (HHS) will lead the
    interagency process and strategic planning and will manage programs
    supporting medical countermeasures development and acquisition for
    domestic preparedness.
           (i)  Stewardship. Not later than 60 days after the date of this
                directive, the Secretary shall establish an interagency
                committee to provide advice in setting medical
                countermeasure requirements and coordinate HHS research,
                development, and procurement activities. The committee will
                include representatives designated by the Secretaries of
                Defense and Homeland Security and the heads of other
                appropriate executive departments and agencies. This
                committee will serve as the primary conduit for
                communication among entities involved in medical
                countermeasure development. The chair of the committee shall
                keep the joint Homeland Security Council/National Security
                Council Biodefense Policy Coordination Committee apprised of
                HHS efforts to integrate investment strategies and the
                Federal Government's progress in the development and
                acquisition of medical countermeasures.
          (ii)  Strategic Planning. Not later than 60 days after the date of
                this directive, the Secretary shall establish a dedicated
                strategic planning activity to integrate risk-based
                requirements across the threat spectrum and over the full
                range of research, early-, mid-, and late-stage development,
                acquisition, deployment, and life-cycle management of
                medical countermeasures. The Secretary shall align all
                relevant HHS programs and functions to support this
                strategic planning.
         (iii)  Execution. The Secretary shall ensure that the efforts of
                component agencies, centers and institutes are coordinated
                and targeted to facilitate both development of near-term
                medical countermeasures and transformation of our capability
                to address future challenges. The Secretary shall also
                establish an advanced development portfolio that targets
                investments in promising countermeasures and technologies
                that are beyond early development, but not yet ready for
                acquisition consideration. In order to realize the full
                potential for broad partnership with academia and industry,
                the Secretary shall ensure that HHS coordinates strategies
                and implementation plans in a manner that conveys integrated
                priorities, activities, and objectives across the spectrum
                of relevant Federal participants.
          (iv)  Engaging the Private Sector and Nongovernmental Entities.
                The Secretary shall develop and implement a strategy to
                engage the unique expertise and capabilities of the private
                sector in developing medical countermeasures to combat WMD,
                and shall provide clear and timely communication of HHS
                priorities and objectives. The Secretary shall consider
                creating an advisory committee composed of leading experts
                from academia and the biotech and pharmaceutical industries
                to provide insight on barriers to progress and help identify
                promising innovations and solutions to problems such as
                life-cycle management of medical countermeasures. The
                Secretary shall designate one office within HHS as the
                principal liaison for nongovernmental entities who wish to
                bring new technologies, approaches, or potential medical
                countermeasures

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                to the attention of the Federal Government.
        (b) The Secretary of Defense shall retain exclusive responsibility
    for research, development, acquisition, and deployment of medical
    countermeasures to prevent or mitigate the health effects of WMD threats
    and naturally occurring threats to the Armed Forces and shall continue
    to direct strategic planning for and oversight of programs to support
    medical countermeasures development and acquisition for our Armed Forces
    personnel. The Secretaries of Health and Human Services and Defense
    shall ensure that the efforts of the Department of Defense (DOD) and HHS
    are coordinated to promote synergy, minimize redundancy, and, to the
    extent feasible, use common requirements for medical countermeasure
    development. The Secretary of Defense shall ensure that DOD continues to
    draw upon its longstanding investment and experience in WMD medical
    countermeasure research, development, acquisition, and deployment to
    ensure protection of the Armed Forces, but also to accelerate and
    improve the overall national effort, consistent with Departmental
    authorities and responsibilities, and shall ensure that DOD continues to
    place a special focus on medical countermeasure development for CBRN
    threat agents because of the unique facilities, testing capabilities,
    and trained and experienced personnel within the Department. These
    efforts will constitute the basis for interagency partnership and
    combined investment to safeguard the American people.
        (c) The Secretary of Homeland Security shall develop a strategic,
    integrated all-CBRN risk assessment that integrates the findings of the
    intelligence and law enforcement communities with input from the
    scientific, medical, and public health communities. Not later than June
    1, 2008, the Secretary of Homeland Security shall submit a report to the
    President through the Assistant to the President for Homeland Security
    and Counterterrorism, which shall summarize the key findings of this
    assessment, and shall update those findings when appropriate, but not
    less frequently than every 2 years. The Department of Homeland Security
    shall continue to issue Material Threat Determinations for those CBRN
    agents that pose a material threat to national security.
        (d) The Secretaries of Health and Human Services, Defense, and
    Homeland Security shall ensure the availability of the infrastructure
    required to test and evaluate medical countermeasures for CBRN threat
    agents.
           (i)   The Secretaries of Health and Human Services, Defense, and
                Veterans Affairs shall leverage their partnership to
                identify and accelerate research, development, testing, and
                evaluation programs for the acquisition of medical
                countermeasures for CBRN threats.
          (ii)   The Secretary of Health and Human Services and the
                Secretary of Homeland Security shall develop effective and
                streamlined processes, including mutually agreed-upon
                timelines, to assist the respective Secretaries in jointly
                recommending that the Special Reserve Fund (SRF) be used for
                the acquisition of specified security countermeasures.
         (iii)   The Director of National Intelligence shall facilitate
                coordination across the intelligence community and, in
                coordination with the Attorney General, engage the law
                enforcement community to provide all relevant and
                appropriate WMD-related intelligence information to DHS for
                the development of the integrated CBRN risk assessment that
                is used in prioritizing the development, acquisition, and
                maintenance of medical countermeasures.

    GENERAL

        (15) This directive:

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        (a) shall be implemented consistent with applicable law and the
    authorities of executive departments and agencies, or heads of such
    departments and agencies, vested by law, and subject to the availability
    of appropriations;
        (b) shall not be construed to impair or otherwise affect the
    functions of the Director of the Office of Management and Budget
    relating to budget, administrative, and legislative proposals; and
        (c) is not intended to, and does not, create any rights or benefits,
    substantive or procedural, enforceable at law or in equity by a party
    against the United States, its agencies, instrumentalities, or entities,
    its officers, employees, or agents, or any other person.

                                                              George W. Bush

    Note: This directive was released by the Office of the Press Secretary
    on February 7.