Pandemic Preparedness Planning
Health oversight organizations around the world have developed pandemic preparedness guidelines. The World Health Organization
(WHO) has published its Global Influenza Preparedness Plan, which serves as the foundation for national and local authorities
to define their own plans. The WHO plan divides a pandemic outbreak into six major phases, shown in Table 3.3 To address the specifics of each community's readiness activities, 11 technical areas have been designated for a pandemic
preparedness plan. These areas are shown in the sidebar (Pandemic Preparedness Planning: Technical Areas of Focus).
Table 3. The World Health Organization plan divides a pandemic outbreak into six major phases.
The Industry Approach
Although there has been significant activity concerning the steps necessary to combat a pandemic outbreak from the perspective
of isolating and managing its impact on the general population, the biopharmaceutical industry's ability to rise to the challenge
remains unclear. In May 2006, the WHO convened a meeting of key stakeholders from national immunization programs, national
regulatory authorities, vaccine manufacturers, and the research community to develop a strategy for combating a pandemic.
The recommendations of that committee were published as part of WHO's Global Pandemic Influenza Action Plan to Increase Vaccine
Supply, in which the organization identified three major approaches:4
1. Increase seasonal immunization programs against influenza for countries with immunization programs.
2. Increase production capacity among the largest vaccine manufacturers.
3. Invest in research and development of new, more rapidly developed vaccines.
The industry's ability to support all three initiatives will determine the ability to respond to an outbreak.
Responding to the Call
The challenges facing the biopharmaceutical industry in the event of a pandemic outbreak are multifold. To meet WHO's pre-paredness
plan requirements, the industry must invest in a carefully considered business continuity (BC) plan. Unlike most BC plans,
this one must go beyond merely restoring operations in the event of a disaster such as a pandemic outbreak; it must focus
on the industry's ability to effectively handle the timeline and technology hurdles created by the antigenic shift potential
of H5N1. The question must be asked: Do the technology and regulatory requirements involved in manufacturing a vaccine inhibit
the biopharmaceutical industry from effectively responding to such a fluid and shifting threat as that posed by the H5N1 avian
Pandemic Preparedness Planning: Technical Areas