Dana Perkins, PhD
Chief of the Biological Weapons Nonproliferation and Counterterrorism Branch, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services. 

DISCLAIMER
The views, opinions, findings, and conclusions expressed in this article are those of the author and do not necessarily represent the views, official policy or position of the U.S. Department of Health and Human Services or its components, or the U.S. Government.

Introduction

John Gray’s goal in writing his famous book Men Are from Mars, Women Are from Venus was to help men and women understand each other better and find ways to bring their relationship back into balance and harmony. Is public health from Venus and security from Mars? Similar to the situations described in John Gray’s book, public health and security communities may have different goals, objectives, and terminology as well as distinct methods. However, the common ground found through communication and information sharing could lead to increased effectiveness and optimization of each other’s resources.

For instance, it took the anthrax attacks of 2001 to bring into the spotlight the necessity of joint public health-law enforcement investigations to foster improved understanding of the investigative objectives and methods specific to each discipline and to strengthen intersectoral collaborative efficacy in response to potential future attacks. Now, a decade later, CDC and FBI are jointly providing regular training on criminal-epidemiological investigations throughout United States and the concept of forensic epidemiology is now part of the formal training of public health and law enforcement investigators and an important tool in mounting responses to bioterrorism and other threats to public health. CDC and FBI also developed a Joint Public Health – Law Enforcement Investigations:  Model Memorandum of Understanding (MOU) to formalize the manner in which joint public health and law enforcement investigations will be conducted following suspected or confirmed intentional acts that pose a threat to the public’s health and to be considered “for adoption by state, tribal, local, and other jurisdictions when developing methods for coordinating joint public health and law enforcement investigations of bioterrorism, suspected bioterrorism, or other public health concerns possibly resulting from deliberate, criminal actions”.

Can public health community work in a similar collaborative fashion with those communities aiming at curtailing biological proliferation activities? Major contributions to health improvements in the past few decades were due to behavioral changes in the population and a focus on preventive medicine. Preventing the deliberate use of biological agents for causing harm thus follows the principles of good preventive medicine.

Our National Health Security Strategy calls for active collaboration and coordination among communities (including private sector and governmental, non-governmental, and academic organizations) to implement measures to prevent, protect against, respond to, and recover from any type of large-scale incident having health consequences. However, it is theNational Strategy for Countering Biological Threats (released roughly in the same time frame) which directly links the public health capabilities requirements with the success of biological nonproliferation activities. Revitalizing the Biological Weapons Convention (BWC) and maximizing its potential to advance international security is a key element of this Strategy and the intersectoral collaborations both domestically and at the international level are emphasized as supporting all its seven strategic objectives.

Of note, the U.S. Opening Statement at the 2008 Meeting of States Parties highlights the fact that the “BWC-related issues have also been a catalyst for ministries to work together in new ways”. It goes on saying that “This is certainly true for the United States. In the past our State Department disarmament specialists had little contact with their Health and Human Services counterparts. They now work hand-in-hand to improve security against infectious disease, whatever the cause…”. The growing nexus between health and security is emphasized by the renewed relevance of BWC for ministries other than foreign affairs and, as stated in the statement mentioned above, “the US believes that it is a sign of progress that governments now send representatives from multiple ministries to BWC meetings”.

Quo vadis BWC?

The Biological Weapons Convention (BWC) which entered into force in 1975, bans the possession, production, stockpiling, or acquisition of biological weapons, and requires States Parties to take steps to prohibit such activities by their citizens.  It also prohibits assisting, encouraging, or inducing others to carry out prohibited activities. As one of the three depositaries of the treaty, the United States is deeply committed to the norm embodied in the BWC and considers the BWC a critical element of international efforts to address the threat posed by biological weapons and related materials and agents in the hands of either state or non-state actors who aim to misuse them to cause harm.

The 2007-2010 Inter-Sessional Program (ISP) of BWC, which entailed annual Meetings of Experts and Meetings of States Parties, provided a unique international forum for States Parties to reach common understandings and seek effective action on specific topics such as: i) National Implementation; ii) Biosafety & Biosecurity; Oversight, Education, and Outreach; iii) Capacity Building for Disease Surveillance, Detection, Diagnosis, and Containment; and iv) Response to Use or Threat of Use of biological weapons. These meetings brought together the public health, security, scientific, and law enforcement communities to work toward identifying and addressing common challenges associated with biological threats.

In 2007, States Parties agreed on the value of:

• Ensuring domestic coordination of implementation efforts;
• Ensuring effective enforcement of legislative and regulatory measures;
• Building capacity to collect evidence and developing early-warning systems;
• Training law enforcement agencies and providing them with adequate scientific and technical support;
• Regional and sub-regional cooperation to support national measures of implementation.

The regional and sub-regional cooperation was further emphasized for its value in:

• Developing common approaches to implementing the BWC;
• Providing relevant assistance and support;
• Engaging regional resources with technical expertise;
• Including discussions of the Convention at regional meetings, as well as ministerial and high-level consultations.

Recognizing that biosafety and biosecurity measures contribute to preventing the development, acquisition or use of biological weapons and are appropriate means of implementing the BWC, States agreed in 2008 on the value of:

• Having national authorities defining and implementing biosafety & biosecurity concepts in accordance relevant national laws, regulations and policies;
• Ensuring measures adopted are practical, sustainable, enforceable, readily understood, developed in concert with national stakeholders, adapted for local needs, and appropriate for the agents being handled and the work being undertaken, while avoiding unduly restricting the pursuit of the biological sciences for peaceful purposes;
• Building networks between scientific communities and academic institutions and increasing interaction with professional associations and working groups at the national, regional and international level.

Also in 2008, States Parties recognized the importance of “ensuring that those working in the biological sciences are aware of their obligations under the Convention and relevant national legislation and guidelines, have a clear understanding of the content, purpose and foreseeable social, environmental, health and security consequences of their activities, and are encouraged to take an active role in addressing the threats posed by the potential misuse of biological agents and toxins as weapons, including for bioterrorism”.

By far, the topic of most interest (as seen by the participation of more than 500 delegates) was undertaken for consideration in 2009. States Parties:

• Agreed on the value of promoting capacity building for disease surveillance, detection, diagnosis, and containment and improving integration of capacity-building activities to effectively use scarce resources;
• Recognized that the collaboration in the context of BWC will complement activities in other forums;
• Noted the fundamental role of international organizations (such as WHO, OIE, FAO, etc) in efforts to combat disease.

States Parties also recognized the importance of building infrastructure such as:

• Surveillance systems and capacity for rapid detection/ pathogen identification;
• Primary health care, veterinary, and phytosanitary services;
• Emergency and epidemiological response capabilities;
• Communication capabilities;
• Appropriate national regulatory frameworks.

Last but not least, at their meetings in 2010 when addressing the response to use or threat of use of biological weapons, States Parties noted several challenges to provision of assistance and coordination with international organizations:

• The need for clear procedures for submitting requests for assistance or responding;
• The need for additional resources;
• The interface between international public health response and international security issues.

With regard to investigations and mitigation of potential impact, States Parties recognized inter alia the value of:

• A coordinated government approach;
• Addressing all possible implications;
• Clear channels of communication and command;
• Accessing expert advice;
• Training and exercises.

States Parties also recognized that:

• They bear primary responsibility for providing assistance and coordination with relevant organizations in the event of an alleged use;
• There is a need to improve their own capacities in surveillance and detection efforts for identifying and confirming outbreaks;
• There is value in improving coordination between law enforcement and health sectors.

The Seventh Review Conference (RevCon) of the BWC was held in Geneva, Switzerland, on 5-22 December 2011. At that time, the States Parties were expected to undertake a thoroughly and comprehensively review of the understandings reached during the 2007-2010 ISP, decide how the next one will be structured, and agree on a declaration setting out our shared vision of the Convention and its implementation. The lessons identified, including the value of intersectoral collaboration, during the 2007-2010 ISP, have not gained much of a momentum at the RevCon, but the entire work program garnered a few paragraphs in the Final Declaration, pointing out the consensus outcome documents of the meetings of States Parties and noting “that the meetings of States Parties and meetings of experts functioned as an important forum for exchange of national experiences and in-depth deliberations among States Parties” and that “the meetings of States Parties engendered greater common understanding on steps to be taken to further strengthen the implementation of the Convention”. The Conference also noted “the contribution by the WHO, FAO, OIE and other relevant international organizations, as well as scientific and academic institutions and non-governmental organizations, to the meetings of States Parties and meetings of experts”.

For the 2012-2015 ISP, the 7th RevCon decided that the following topics shall be Standing Agenda Items, which will be addressed at meetings of both the Meeting of Experts and Meeting of States Parties in each year from 2012 to 2015:

(a) Cooperation & assistance, with a particular focus on strengthening cooperation & assistance under Article X;
(b) Review of developments in the field of science and technology related to the Convention;
(c) Strengthening national implementation.

The Conference also decided that the following other items will be discussed during the intersessional program in the years indicated:

(a) How to enable fuller participation in the CBMs (in 2012 and 2013);
(b) How to strengthen implementation of Article VII, including consideration of detailed procedures and mechanisms for the provision of assistance and cooperation by States Parties (in 2014 and 2015).

It remains to be seen whether the 2012-2015 ISP will build on the success of the previous work program and put the BWC on a trajectory to address the full spectrum of 21^st century biological risks – which include not only the threat of state-level BW programs, but also challenges posed by non-state actors empowered by technological advances and the risk of rapid global spread of infectious disease driven by international transportation and commerce. Of note the words “science” and “disease” doubled in frequency in the 7^th RevCon Final Document (Solemn Declaration plus article by article statements) –Word Cloud shown in Figure 1, compared to the 6^th RevCon Final Document.

BWC and HHS

The U.S. Department of Health and Human Services (HHS) actively supports the Department of State’s diplomatic and political demarches with regard to BWC, recognizing its increased significance for the norm of peaceful and prophylactic use of life science and medical technologies that it embodies – and also for the fact that BWC has evolved into a multilateral forum where public health, scientific, security, and law enforcement communities come together to discuss global disease challenges and the need for strengthening our collective capacity for public health preparedness and response to public health emergencies of international concern.

HHS has critical responsibilities in implementing the BWC tenets and obligations domestically as a result of its authorities conferred inter alia by:

• The Antiterrorism & Effective Death Penalty Act of 1996 (which directed HHS to establish a list of biological agents and toxins with the potential to threaten public health and safety, develop procedures governing the transfer of those agents, and set training requirements for entities working with these “select agents”)
• USA Patriot Act of 2001 (which places restrictions on persons who possess Select Agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes)
• The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which strengthened the Select Agents Program to keep Select Agents and toxins out of the reach of individuals who might intend to misuse them)
• The Public Health Service Act (42 U.S. Code § 264) which authorizes the U.S. Secretary of Health and Human Services to take measures to prevent the entry and spread of communicable diseases from foreign countries into the U.S. and between states

HHS also contributes significantly to the implementation of BWC Article X (which grants the States Parties the right to participate in, and the responsibility to facilitate, the exchange of equipment, materials and information for the use of biological agents for peaceful purposes, as well as scientific cooperation in the field).

Establishing effective and sustainable national and global surveillance systems for human, animal and plant diseases is a key element of Article X implementation which enables the development and application of scientific discoveries for the detection, prevention and countering of disease.  Disease surveillance and response to public health emergencies constitute areas where States Parties are willing to work together and in partnership with international organizations (such as WHO, OIE, and FAO). As emphasized by Ambassador Kennedy at the 2010 BWC Meeting of States Parties, “the provisions of BWC Article X reinforce those of International Health Regulations Article 44, which calls for collaboration in the development, strengthening, and maintenance of required public health capacities”.

The overlap between BWC and IHRs obligations as well as their respective contributions to national preparedness and response were highlighted in the three workshops and tabletop exercises organized jointly by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in HHS and the U.S. Department of Defense, as follows:

• The Southern Caucasus Workshop on Public Health, Security, and Law Enforcement Partnership in Bio-Incident Pre-Planning and Response and the associated Southern Caucasus BioShield 2010 Tabletop Exercise, in Tbilisi, Georgia, 11-12 May 2010;
• The Trilateral (US-Romania-Moldova) Civilian-Military Forum on Outbreak Response and Bioterrorism Investigation (ORBIT Forum and Tabletop Exercise), held in Chisinau, Republic of Moldova, 19-21 October 2010;
• Countering Biological Threats: National Implementation of the Biological Weapons Convention and Multinational Outbreak Response and Bioterrorism Investigation Demonstration, in Tbilisi, Georgia, 17-19 May 2011.

The United States’ international avian and pandemic preparedness efforts in more than 100 nations and jurisdictions (primarily led by CDC and focused on: i) preparedness and communication; ii) surveillance and detection, and iii) response and containment), BARDA’s grants to the WHO to strengthen developing countries’ ability to produce flu vaccines and its ongoing international cooperative agreement with WHO in the Initiative for Vaccine Research, the NIH Fogarty International Center’s activities promoting global health research and training, and FDA’s international capacity building efforts and its work with other government agencies and private sector organizations to help reduce the risk of tampering or other malicious, criminal, or terrorist actions on the food and cosmetic supply, are all examples of activities toward fulfillment of U.S. obligations under Article X of BWC.  

On behalf of HHS, the Office of the Assistant Secretary for Preparedness and Response (ASPR) is supporting the U.S. Department of State in its public diplomacy demarches related to BWC; represents HHS in the Arms Control Interagency Policy Coordination Committee, the Deputies Committee meetings, and in the U.S. delegation to the BWC; coordinates the annual HHS reporting on Confidence Building Measures (CBMs); participates in international outreach efforts; and it has a key role in implementing the BWC tenets through a legal, policy, and regulatory framework on biological risk management and effective oversight of its biodefense programs.

ASPR’s participation in the BWC activities is in accordance with the Pandemic and All-Hazards Preparedness Act (PAHPA) which authorizes ASPR to “provide leadership in international programs, initiatives, & policies that deal with public health and medical emergency preparedness and response”

ASPR’s participation in the BWC activities also helps “strengthening its leadership role in coordinating and developing public health and medical emergency preparedness, response, and recovery policy for the Department” (in accordance to ASPR’s Strategic Plan 2011-2015) by:

• Developing policy and fostering partnerships to balance maintaining a robust life sciences enterprise with enhancing laboratory safety and security and reducing the risk from hazardous biologic agents and toxins
• Enhancing strategic engagement with other governments and international organizations through bilateral and multilateral partnerships and initiatives, and
• Supporting the development of U.S. policies, plans, and frameworks to support international public health emergency preparedness, response, & recovery efforts

To support public awareness and transparency of its activities in accordance with the Open Government initiative, ASPR has established a website to highlight the HHS support to biological weapons non-proliferation activities led by the State Department. ASPR has also established a website to promote transparency and broader awareness about the evolving nature of biological agents that can be hazardous, and how to handle and use these agents safely and securely.

Concluding remarks

The nature of threats to public health has changed dramatically in the past century due to globalization, changing patterns of infectious disease emergence as well bioterrorism. However, the public health response is always aimed at saving lives regardless whether the incident is due to natural or accidental causes or a deliberate attack. The international health and security communities of like-minded states have come to realize the value of working collaboratively in the health-security nexus and the newly found relevance of BWC in addressing 21^st century biological threats through its undertaking of topics that encompass both health and security activities in its quest to seek common understandings and effective action in a multilateral forum.

As Kofi Annan, the former UN Secretary General said in 2006, “We must look [at the BWC] as part of an interlinked array of tools, designed to deal with an interlinked array of problems”.