Professor Barry Kellman International Security & Biopolicy Institute

1. AN 8-STEP STRATEGY FOR BIOVIOLENCE MEDICAL COUNTERMEASURE (MCM) PREPAREDNESSBWC Meeting of Experts, 24 – 28 Aug., 2009 Professor Barry Kellman International Security & Biopolicy Institute

2. COORDINATE MCM R&D PLANNING • Establish an international biodefense task force to: • Advise on scientific and technical issues; identify hazards, probability of specific bioviolence attacks, and predictable consequences • Enhance information gathering regarding MCMs • Engage private sector in planning process

3. STRENGTHEN, HARMONIZE MCM QUALITY STANDARDS • Adapt WHO “Good Manufacturing Principles” for bioviolence MCMs • Impel States to build capacity for complying with such standards • Incentives • Industrial inspection scheme

4. HARMONIZE MCM LICENSING • International Conference on Harmonization (ICH) • Harmonizes national rules for regulatory processes by producing a single set of technical requirements for registering new drug products • WHO, UNICEF, UNFPA, World Bank, others: Model Quality Assurance System for Procurement Agencies • Focuses on prequalification of products and manufacturers; purchase; storage; and distribution • Global Harmonization Task Force (GHTF) • Build national regulatory licensing capacity for recognizing other States’ licensing decisions • Bi- and multi-lateral agreements among regulatory authorities to coordinate MCM approval processes

5. HARMONIZE STANDARDS FOR MCM EMERGENCY USE AUTHORIZATION • State-legislated process to designate standards for emergency use of MCMs; standards should address: • Lethality of threat • Timeframe • Potential consequences of using unauthorized MCM • Dissemination strategies to lessen consequences • Availability of proposed MCM • Plan for use of unauthorized MCMs • Instruct response personnel re standards and methods of use • Track side effects and efficacy • Distribute treatments for known side effects of approved MCMs

6. CLARIFY LEGAL RIGHTS OF MCM PRODUCERS • Harmonize standards for compulsory licensing of patented MCMs • Allow domestic producers to manufacture a patented item without the patent holder’s consent • Limited to meeting domestic needs, not for export; patent holder is to be paid adequate compensation • Harmonize standards for “fault” of the producer • Failure to accurately disclose risks during approval process • Substandard product delivered • Failure to provide sufficient use instructions

7. DEVELOP INTERNATIONAL MCM STOCKPILING ARCHITECTURE • Assess, identify, and describe: • Location • of major cities and targets; degree of spread across States and regions; and proximity to transnational transportation networks • MCM procurement and surge capacities • Deployment tactics relevant to each agent • Stockpile content requirements based on threat assessment • Build upon, expand initiative of Global Health Security Action Group (GHSAG)

8. PROMOTE MCM STOCKPILING SECURITY AND SURITY • Surety governs the proper storage and maintenance of stockpile assets. • Adapt WHO’s Guidelines on the International Packaging and Shipping of Vaccines to address specific challenges of bioviolence MCMs • Stockpile security • Site security: paramilitary forces, national guards, military personnel, local police forces. • Considerations: law enforcement, fire control, restricted areas, vehicle traffic, crowd control, coordination with local police • Training and exercises

9. ENCOURAGE PLANNING FOR MCM DELIVERY • Develop model plans for • Command and control lines of responsibility • Define decisional hierarchies, timelines, and oversight modalities • Assign responsibilities for triggering MCM stockpile delivery • Distribution logistics • Select transportation methods and contingency options • Integrate with delivery of conventional medical supplies • Local readiness to receive MCMs • Select dispensation methodologies; instruct response personnel • Prepare major cities for local response (exercises) • Assist States to improve capacities to implement MCM delivery plans