[Weekly Compilation of Presidential Documents Volume 43, Number 6 (Monday, February 12, 2007)]
[Pages 128-134]
[Online from the Government Publishing Office, www.gpo.gov]
<R04>
Directive on Medical Countermeasures Against Weapons of Mass Destruction
January 31, 2007
Homeland Security Presidential Directive/HSPD-18
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
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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.
(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
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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.
(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
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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.
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
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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.
(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
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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 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
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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:
(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.