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THE WHITE HOUSE

Office of the Press Secretary

For Immediate Release April 1, 1993
"Comprehensive Child Immunization Act of 1993"

FACT SHEET

The President today sent to the Congress the "Comprehensive Child
Immunization Act of 1993". This bill is the first legislative
proposal he has sent to the Congress for consideration and
enactment. When enacted, the bill will assure that all children
in the United States are protected against vaccine-preventable
infectious diseases by their second birthday. This legislation
inaugurates a new collaborative partnership among parents and
guardians; health care providers; vaccine manufacturers; and
Federal, State, and local governments to protect our children
from the deadly onslaught of infectious diseases.

This legislation would:

o beginning in fiscal year 1995, authorize the Secretary of
Health and Human Services to purchase and provide childhood
vaccines in quantities sufficient to meet the immunization
needs of children in the United States;

o establish a national immunization tracking system, through
grants to the States to establish State immunization
registries, to ensure that children receive their scheduled
immunizations at the earliest appropriate age;

o ensure that the National Vaccine Injury Compensation
Program, an essential link in our Nation's immunization
system, remains operational; and

o continue vaccine infrastructure enhancements started in my
economic stimulus program.

Background

Immunizations represent one of the most cost-effective means of
disease prevention. Although Federal support for childhood
immunization has been in existence since 1962, the full potential
of immunizations remains to be achieved.

Approximately 80 percent of vaccine doses should be received
before the second birthday in order to protect children during
their most vulnerable periods. Unfortunately, many children do
not receive their basic immunizations by that time. In fact, in
some inner city areas as few as 10 percent of 2-year olds have
received a complete series. This low level of immunizations has
been reflected in recent years in outbreaks of measles among un-
immunized preschool children. The resurgence of measles in 1989
through 1991 afflicted over 55,000 people and cost the country
$20 million in avoidable hospital costs alone.

In 1982, the recommended vaccine schedule cost $6.69 in the
public sector and $23.29 in the private sector. By 1992, the
total cost for fully immunizing a child was $122.28 in the public
sector and $244.10 in the private sector.

Legislative Proposal

The problem posed by soaring vaccine costs is exacerbated by a
deteriorated immunization infrastructure. This legislation
continues the rebuilding of our capacity to deliver vaccines and
educate parents started in my economic stimulus package. With
this bill, our Nation's vaccine infrastructure will continue to
be revitalized, including delivery, safety and research capacity,
patient and vaccine tracking ability, and the community-based
outreach and information campaign.

To remove the financial barriers to immunization that impede
children from being vaccinated on time, and to facilitate
development of a national tracking system, we must begin Federal
purchase of all vaccines recommended for universal use in
children.

Universal Vaccine Purchase and Provision

The bill would require that the Secretary consult with other
Federal agencies for advice on the quantities of recommended
childhood vaccine to be purchased. It would authorize the
Secretary to consult with representatives of State governments,
experts in vaccine delivery, health care providers, and other
experts prior to commencing negotiations for the purchase of
vaccine.

This proposal would direct the Secretary to negotiate a
reasonable price with manufacturers participating in a
procurement. The price would be based on data supplied to the
Secretary by manufacturers regarding (1) costs related to
research and development, production, distribution to States and
health care providers, and marketing; (2) profit levels
sufficient to encourage future investment in research and
development; and (3) the ability to maintain adequate outbreak
control. In addition, the bill would require that data provided
to the Secretary be treated as a trade secret or confidential
information for purposes of the Freedom of Information Act and
would provide criminal sanctions for violations of this
provision.

Under this legislation, the Secretary would provide (either
directly or through the States) for the free distribution of
vaccines to health care providers who serve children and are

located in a State that participates in the State registry grant
program. In non-participating States, free vaccine will be
distributed to Federal health care providers, community health
centers, migrant health centers, health centers serving residents
of public housing or the homeless, other federally qualified
health centers, and health care providers serving Indians
pursuant to the Indian Self-Determination Act or section 503 of
the Indian Health Care Improvement Act.

Under the Act, health care providers could not charge patients
for the cost of the vaccine, but may impose a fee for its
administration unless such a fee would result in the denial of a
vaccine to someone unable to pay.

Finally, the bill provides that the authority of the Secretary
established under this legislation to purchase and provide
vaccines shall cease to be in effect beginning on such date as
may be specified in a Federal law providing for immunization
services for all children as part of a broad-based reform of the
national health care system.

State Immunization Registries

The bill provides for a collaborative Federal and State effort to
track the immunization status of the Nation's children. It
authorizes the Secretary to make grants to States to establish
and operate State immunization registries containing specific
information for each child in the State. Entering infant birth
data into registries will enable the identification of children
who need vaccinations and will help parents and providers assure
that children are appropriately immunized.

Providers would be required to report to the State tracking
registry (or to the Secretary if there is no State registry)
information regarding each vaccine administered and their
periodic estimates of the future vaccine needs. For each child,
information will be gathered on immunization history, including
types and lot numbers of vaccines received, health care provider
identifiers, and adverse reactions associated with the
immunizations. In addition, the State immunization registries
will provide vital information on safety and efficacy of vaccines
by linking administrative records with adverse reactions
reporting and disease outbreak patterns.

The National Vaccine Compensation Program

A keystone to the Nation's vaccine immunization effort is the
National Vaccine Injury Compensation Program. This proposal
would amend the Internal Revenue Code to allow payments from the
Trust Fund for compensable injuries from vaccines administered on
or after October 1, 1992. It would authorize appropriations from
the Trust Fund for years after fiscal year 1992 for
administrative costs to carry out the National Vaccine Injury
Compensation Program. In addition, it would provide for a
permanent extension and reinstatement of the vaccine excise tax
and repeal the Internal Revenue Code provision that authorizes
the Secretary of the Treasury to terminate the vaccine excise
tax.

Other provisions related to the National Vaccine Injury
Compensation program state that any vaccine recommended for
universal administration to children by the Secretary would be
included on the Vaccine Injury Table. The bill would provide the
Secretary authority, with respect to any vaccine so added, to
modify the Table, but only in accordance with notice, hearing,
and comment procedures, and other limitations. The chief special
master would be allowed to suspend proceedings on petitions from
retrospective claims for up to 30 months, rather than the 540
days (or 18 months) in current law.

Finally, vaccine information materials would be simplified by
replacing the detailed list of items that must be addressed in
the information materials with a requirement for a concise and
understandable statement of the benefits and risks of the
vaccine, and the availability of the National Vaccine Injury
Compensation Program.

Funding

For the purpose of making State registry grants, the bill would
authorize appropriations of $152 million for fiscal year 1995,
$125 million for fiscal year 1996, and $35 million for each of
the fiscal years 1997, 1998, and 1999. In addition, the bill
would authorize appropriations of such sums as may be necessary
for fiscal years 1993 and 1994 for start up costs associated with
activities to implement the "Comprehensive Child Immunization Act
of 1993."

Beginning in fiscal year 1995, the bill would authorize the
Secretary to carry out the program of vaccine purchase and
distribution from the Comprehensive Child Immunization Account in
the United States Treasury. The sources of revenue that will be
deposited into the Comprehensive Child Immunization Account for
the vaccine purchase and distribution program will be identified
in legislation for broad-based reform of the national health care
system when it is submitted to the Congress by the President in
May.

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