President Clinton signs legislation for vaccine tax

Taxpayer Relief Act of 1997 sets vaccine flat tax at 75 cents per dose.

[Legislation required]

[Your turn]

September 1997

Special Report

ROCKVILLE, Md. — On Aug. 5, President Clinton signed the Taxpayer Relief Act of 1997 containing amendments to revise the excise tax on vaccines covered under the Vaccine Injury Compensation Program (VICP).

The act contains amendments to revise the current excise tax structure to provide a flat rate of 75 cents per dose. The act, therefore, adds coverage for three new childhood vaccines recently added to the Vaccine Injury Table. These vaccines include: hepatitis B (HepB), Haemophilus influenzaetype b (Hib) and varicella.

The 75 cents per dose "flat tax" rate also is applicable to the vaccines covered under the previous Vaccine Injury Tables. For example, diphtheria-tetanus-pertussis vaccine (DTP) which was taxed at $4.56 is reduced to $2.25; oral poliovirus vaccine (OPV) increases from 29 cents to 75 cents; and measles-mumps-rubella vaccine (MMR) will decrease from $4.44 to $2.25.

The revised tax structure and addition of new vaccines for coverage under the VICP took effect on Aug. 6.

Legislation required

The National Childhood Injury Act of 1986 established the National Vaccine Injury Compensation Program (VICP) as a federal "no-fault" compensation system for individuals who may have been injured by specific covered vaccines. Entering its 10th year of operation, the VICP has ensured childhood vaccine supplies by dramatically reducing vaccine companies’ and providers’ liability that threatened the production of vaccines during the 1980s.

The Vaccine Injury Table lists specific injuries or condition and time frames following vaccination that may be compensated under the VICP. The table establishes legal presumptions about causation, which are used by the U.S. Court of Federal Claims to adjudicate petitions. As part of the act, Congress mandated a review of the scientific literature and other information on specific adverse consequences of various childhood vaccines.

The Institute of Medicine (IOM) performed and published reports of these reviews in 1991 and 1993 and a review of a follow-up study of the National Childhood Encephalopathy Study in 1994. Based on the IOM reports and reviews of these reports, the Secretary of Health and Human Services Donna E. Shalala proposed changes to the table in 1995 and again this year to better reflect current scientific knowledge about vaccine injuries. The most recently revised table, effective March 24, includes the following changes:

• HepB, Hib and varicella vaccines are added to the table for coverage under the VICP.
• A general category is added for any new vaccine that the CDC recommends in the future for routine administration to children.
• Brachial neuritis is added for vaccines against tetanus.
• Thrombocytopenic purpura is added for vaccines against measles.
• Vaccine-strain polio viral infection isolated from a tissue is added for oral polio vaccine.
• Residual seizure disorder is removed for vaccines against measles, mumps and rubella, alone or in combination.

The VICP has received 5,169 petitions filed for possible injury from vaccines covered under the VICP; 4,243 filed for vaccines administered before October 1988 and 926 for vaccines administered between October 1988 and August 1996. Over 4,100 claims have been adjudicated, 1,175 of which have been found to be compensable, and the remainder have been dismissed.

Vaccine injury claims filed with the VICP after Aug. 5 will be adjudicated under the recently revised table. To obtain information about the VICP, how to file a claim, criteria for eligibility and the documentation required, call 800-338-2382 or visit the web page at http://www.hrsa.dhhs.gov/bhpr/vicp. For information about rules of the court and filing a petition, call 202-219-9657.

Michele Puryear, MD, PhD, is a medical officer with the National Vaccine Injury Compensation Program.

For more information:

• The National Childhood Vaccine Injury Act of 1986. Public Health Service Act §2125. (42 U.S.C. §300aa-25[supp. 1987]).
• CDC. National Childhood Vaccine Injury Act requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200.