On February 15th, Senator Edward Kennedy introduced S.2291, The <a href=”http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.02291:”Responsible Public Readiness and Emergency Preparedness Act, which aims to expand compensation and clarify liability issues that will arise if untested vaccines and countermeasures need to be distributed in the event of a pandemic disease outbreak.
The move is clearly designed to revise the sweeping liability protection inserted as part of the Public Readiness and Emergency Preparedness Act in the Defense spending bill conference report. That bill is widely regarded as incomplete since it does not provide for funding for a vaccine injury compensation program. It has also been widely criticized for providing overly zealous liability coverage of drug and vaccine companies as well as those delivering countermeasures to patients. In fact, it requires that for any injured person to get around the liability protection, they have to prove that a drug company or medical professional administering the drug or vaccine engaged in “willful misconduct.” This is, of course, next to impossible.
The new bill
Senator Kennedy’s bill repeals the measures from the defense spending bill and takes a more balanced approach.
First, the bill provides more limited liability for drug companies and those delivering medications and defines a narrow scope of products that it would apply to. They specifically design it so that drugs that have already been FDA approved are not covered since they have already been thoroughly tested. Liability coverage is only extended to products that are not FDA approved and have been designated by the Secretary of the Department of Health and Human Services to be necessary to fight an epidemic.
Second, the bill defines a real compensation program that is modeled after the existing Vaccine Injury Compensation program. Therefore, no money needs to be appropriated for a fund that might never be used. This approach has been pushed by several advocacy groups.
Third, the bill provides a way for the government to sue a vaccine or drug manufacturer or medical professional to recover payments made through the vaccine compensation program for negligence.
Now all we need is for the partisanship in the Senate to disappear so bills like this have a fighting chance.