US Declares `Potential Pandemic Emergency'

 

# 395

 

Largely lost in shuffle over the coverage of the CDC's news conference yesterday, Mike Leavitt, using the provisions of  PREP ACT, declared that there was a credible risk of a pandemic, and extended liability protection to vaccine manufacturers.

 

This from the Congressional Quarterly.

 

 

Avian Flu Declaration May Spur Firms to Develop Vaccines Without Fearing Liability

By Matthew E. Berger, CQ Staff   Feb. 1, 2007 – 7:29 p.m.

 

The federal government has declared a potential pandemic emergency, prompting liability protection for avian influenza vaccine manufacturers.

 

Health and Human Services Secretary Michael O. Leavitt made the declaration, which became public Thursday, as required under the Public Readiness and Emergency Preparedness (PREP) Act. The declaration says there is “credible risk that the spread of avian influenza viruses and resulting disease could in the future constitute a public health emergency.”

 

The notice is expected to help persuade manufacturers of pandemic vaccines and countermeasures to contract with the government, without fear of liability if their drugs are misused or have unknown effects.

 

Analysts said it also puts the government on record about the likelihood of a pandemic.

 

“The big news is that you now have a very strong pronouncement by [the Department of Health and Human Services] that the threat of the avian flu pandemic is significant,” said John Clerici, a biodefense consultant.

 

The PREP Act passed in December as part of the Defense Department’s fiscal 2007 spending bill (PL 109-148). It was designed to give the government the ability to plan ahead of time for a pandemic by stockpiling drugs, while alleviating the fears of drug manufacturers wary of sending drugs to the Strategic National Stockpile before they were fully approved.

 

While declaring a `Potential Pandemic Emergency' may sound dire, it is actually more of a formality.  The PREP act has been in existence for more than a year.  Invoking it may well indicate an increase in the level of concern in Washington, but it doesn't mean a pandemic is imminent.

 

This from the Federal Government's pandemic page

 

Public Readiness and Emergency Preparedness Act (PREP Act) for Pandemic Influenza Medical Countermeasures Utilization Protocol & Decision Tools

BACKGROUND

The Public Readiness and Emergency Preparedness Act (PREP Act) (Pub. L. 109-148), provides immunity from liability claims arising from administration and use of covered countermeasures to manufacturers, distributors, program planners and qualified persons involved in the administration and use of a covered countermeasure, as specified in a declaration by the Secretary of HHS [See section 319F-3 of the Public Health Service Act (42 U.S.C. §247d-6d)]. The exception to this immunity is willful misconduct acts by the covered persons.

 

The concept of granting vaccine manufacturers immunity is a controversial one, particularly after the experience in 1976 during the Swine Flu scare, when hundreds were either killed or injured by the vaccine.  Since then, most of the vaccine manufacturers have moved offshore, and our ability to produce vaccines here in the United States has greatly diminished.

 

The PREP act speaks of a compensation fund, but gives no details beyond.

 

If funds are appropriated for the Covered Countermeasure Process Fund under subsection (a), then HHS provides compensation to an eligible individual for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to the declaration in accordance with Public Law 109-148.

 

This legislation will not sit well with those who see it as more government protection extended to big pharmacy, but proponents are quick to point out, if we want a vaccine in a pandemic, we have to be prepared to exempt the manufacturers from liability.

 

Tough choices.

 

Another escalation in what seems to be a rapidly moving world of pre-pandemic planning.