Requires the Secretary of Health and Human Services to provide for a program of research, demonstration projects, and education to ensure that immunizations are routinely offered to adults and adolescents by public and private health care providers. Requires such program to collect data on adverse impacts associated with immunizations.
Directs the Secretary to: (1) develop and disseminate information concerning certain diseases and their vaccines, including bacterial meningitis and hepatitis A and B; and (2) maintain a 6 months supply of prioritized vaccines.
Revises provisions governing the National Vaccine Injury Compensation Program, including provisions regarding: (1) equitable relief; (2) parent petitions; (3) jurisdiction to dismiss improperly brought claims; (4) vaccine-unrelated injury; (5) the basis for calculating projected lost earnings; (6) compensation for family counseling and establishing guardianship expenses; (7) payment of interim costs; (8) procedures for paying attorney's fees; (9) extending the statute of limitations; (10) the composition and meeting schedule of the Advisory Committee on Childhood Vaccines; and (11) standards of responsibility and the definitions of manufacturer, vaccine-related injury or death, and vaccine.
Requires the Secretary to contract with the Institute of Medicine of the National Academy of Science to conduct an ongoing, comprehensive review of new scientific data on childhood vaccines.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5282 Introduced in House (IH)]
107th CONGRESS
2d Session
H. R. 5282
To amend the Public Health Service Act to improve immunization rates by
increasing the distribution of vaccines and improving and clarifying
the vaccine injury compensation program, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 26, 2002
Mr. Greenwood (for himself and Mr. Towns) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to improve immunization rates by
increasing the distribution of vaccines and improving and clarifying
the vaccine injury compensation program, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Improved Vaccine
Affordability and Availability Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--STATE VACCINE GRANTS
Sec. 101. Availability of influenza vaccine.
Sec. 102. Program for increasing immunization rates for adults and
adolescents; collection of additional
immunization data.
Sec. 103. Immunization awareness.
Sec. 104. Supply of vaccines.
TITLE II--VACCINE INJURY COMPENSATION PROGRAM
Sec. 201. Administrative revision of vaccine injury table.
Sec. 202. Equitable relief.
Sec. 203. Parent petitions for compensation.
Sec. 204. Jurisdiction to dismiss actions improperly brought.
Sec. 205. Clarification of when injury is caused by factor unrelated to
administration of vaccine.
Sec. 206. Basis for calculating projected lost earnings.
Sec. 207. Allowing compensation for family counseling expenses and
expenses of establishing guardianship.
Sec. 208. Allowing payment of interim costs.
Sec. 209. Procedure for paying attorneys' fees.
Sec. 210. Extension of statute of limitations.
Sec. 211. Advisory commission on childhood vaccines.
Sec. 212. Clarification of standards of responsibility.
Sec. 213. Clarification of definition of manufacturer.
Sec. 214. Clarification of definition of vaccine-related injury or
death.
Sec. 215. Clarification of definition of vaccine.
Sec. 216. Ongoing review of childhood vaccine data.
Sec. 217. Pending actions.
Sec. 218. Report.
TITLE I--STATE VACCINE GRANTS
SEC. 101. AVAILABILITY OF INFLUENZA VACCINE.
Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j))
is amended by adding at the end the following:
``(3)(A) For the purpose of carrying out activities relating to
influenza vaccine under the immunization program under this subsection,
there are authorized to be appropriated such sums as may be necessary
for each of fiscal years 2003 and 2004. Such authorization shall be in
addition to amounts available under paragraphs (1) and (2) for such
purpose.
``(B) The authorization of appropriations established in
subparagraph (A) shall not be effective for a fiscal year unless the
total amount appropriated under paragraphs (1) and (2) for the fiscal
year is not less than such total for fiscal year 2000.
``(C) The purposes for which amounts appropriated under
subparagraph (A) are available to the Secretary include providing for
improved State and local infrastructure for influenza immunizations
under this subsection in accordance with the following:
``(i) Increasing influenza immunization rates in
populations considered by the Secretary to be at high risk for
influenza-related complications and in their contacts.
``(ii) Recommending that health care providers actively
target influenza vaccine that is available in September,
October, and November to individuals who are at increased risk
for influenza-related complications and to their contacts.
``(iii) Providing for the continued availability of
influenza immunizations through December of such year, and for
additional periods to the extent that influenza vaccine remains
available.
``(iv) Encouraging States, as appropriate, to develop
contingency plans (including plans for public and professional
educational activities) for maximizing influenza immunizations
for high-risk populations in the event of a delay or shortage
of influenza vaccine.
``(D) The Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, periodic reports
describing the activities of the Secretary under this subsection
regarding influenza vaccine. The first such report shall be submitted
not later than June 6, 2003, the second report shall be submitted not
later than June 6, 2004, and subsequent reports shall be submitted
biennially thereafter.''.
SEC. 102. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR ADULTS AND
ADOLESCENTS; COLLECTION OF ADDITIONAL IMMUNIZATION DATA.
(a) Activities of Centers for Disease Control and Prevention.--
Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j)), as
amended by section 101, is further amended by adding at the end the
following:
``(4)(A) For the purpose of carrying out activities to increase
immunization rates for adults and adolescents through the immunization
program under this subsection, and for the purpose of carrying out
subsection (k)(2), there are authorized to be appropriated $50,000,000
for fiscal year 2003, and such sums as may be necessary for each of the
fiscal years 2004 through 2006. Such authorization is in addition to
amounts available under paragraphs (1), (2), and (3) for such purposes.
``(B) In expending amounts appropriated under subparagraph (A), the
Secretary shall give priority to adults and adolescents who are
medically underserved and are at risk for vaccine-preventable diseases,
including as appropriate populations identified through projects under
subsection (k)(2)(E).
``(C) The purposes for which amounts appropriated under
subparagraph (A) are available include (with respect to immunizations
for adults and adolescents) the payment of the costs of storing
vaccines, outreach activities to inform individuals of the availability
of the immunizations, and other program expenses necessary for the
establishment or operation of immunization programs carried out or
supported by States or other public entities pursuant to this
subsection.
``(5) The Secretary shall annually submit to Congress a report
that--
``(A) evaluates the extent to which the immunization system
in the United States has been effective in providing for
adequate immunization rates for adults and adolescents, taking
into account the applicable year 2010 health objectives
established by the Secretary regarding the health status of the
people of the United States; and
``(B) describes any issues identified by the Secretary that
may affect such rates.
``(6) In carrying out this subsection and paragraphs (1) and (2) of
subsection (k), the Secretary shall consider recommendations regarding
immunizations that are made in reports issued by the Institute of
Medicine.''.
(b) Research, Demonstrations, and Education.--Section 317(k) of the
Public Health Service Act (42 U.S.C. 247b(k)) is amended--
(1) by redesignating paragraphs (2) through (4) as
paragraphs (3) through (5), respectively; and
(2) by inserting after paragraph (1) the following:
``(2) The Secretary, directly and through grants under paragraph
(1), shall provide for a program of research, demonstration projects,
and education in accordance with the following:
``(A) The Secretary shall coordinate with public and
private entities (including nonprofit private entities), and
develop and disseminate guidelines, toward the goal of ensuring
that immunizations are routinely offered to adults and
adolescents by public and private health care providers.
``(B) The Secretary shall cooperate with public and private
entities to obtain information for the annual evaluations
required in subsection (j)(5)(A).
``(C) The Secretary shall (relative to fiscal year 2001)
increase the extent to which the Secretary collects data on the
incidence, prevalence, and circumstances of diseases and
adverse events that are experienced by adults and adolescents
and may be associated with immunizations, including collecting
data in cooperation with commercial laboratories.
``(D) The Secretary shall ensure that the entities with
which the Secretary cooperates for purposes of subparagraphs
(A) through (C) include managed care organizations, community-
based organizations that provide health services, and other
health care providers.
``(E) The Secretary shall provide for projects to identify
racial and ethnic minority groups and other health disparity
populations for which immunization rates for adults and
adolescents are below such rates for the general population,
and to determine the factors underlying such disparities.''.
SEC. 103. IMMUNIZATION AWARENESS.
(a) Development of Information Concerning Meningitis.--
(1) In general.--The Secretary of Health and Human
Services, in consultation with the Director of the Centers for
Disease Control and Prevention, shall develop and make
available to entities described in paragraph (2) information
concerning bacterial meningitis and the availability and
effectiveness of vaccinations for populations targeted by the
Advisory Committee of Immunization Practices (an advisory
committee established by the Secretary of Health and Human
Services, acting through the Centers for Disease Control and
Prevention).
(2) Entities.--An entity is described in this paragraph if
the entity--
(A) is--
(i) a college or university; or
(ii) a prison or other detention facility;
and
(B) is determined appropriate by the Secretary of
Health and Human Services.
(b) Development of Information Concerning Hepatitis.--
(1) In general.--The Secretary of Health and Human
Services, in consultation with the Director of the Centers for
Disease Control and Prevention, shall develop and make
available to entities described in paragraph (2) information
concerning hepatitis A and B and the availability and
effectiveness of vaccinations with respect to such diseases.
(2) Entities.--An entity is described in this paragraph if
the entity--
(A) is--
(i) a health care clinic that serves
individuals diagnosed as being infected with
HIV or as having other sexually transmitted
diseases;
(ii) an organization or business that
counsels individuals about international travel
or who arranges for such travel;
(iii) a police, fire or emergency medical
services organization that responds to natural
or man-made disasters or emergencies;
(iv) a prison or other detention facility;
(v) a college or university; or
(vi) a public health authority or
children's health service provider in areas of
intermediate or high endemnicity for hepatitis
A as defined by the Centers for Disease Control
and Prevention; and
(B) is determined appropriate by the Secretary of
Health and Human Services.
SEC. 104. SUPPLY OF VACCINES.
(a) In General.--The Secretary of Health and Human Services, acting
through the Director of the Centers for Disease Control and Prevention,
shall prioritize, acquire, and maintain a supply of such prioritized
vaccines sufficient to provide vaccinations throughout a 6-month
period.
(b) Proceeds.--Any proceeds received by the Secretary of Health and
Human Services from the sale of vaccines contained in the supply
described in subsection (a), shall be available to the Secretary for
the purpose of purchasing additional vaccines for the supply. Such
proceeds shall remain available until expended.
(c) Authorization of Appropriations.--There are authorized to be
appropriated for the purpose of carrying out subsection (a) such sums
as may be necessary for each of fiscal years 2003 through 2008.
TITLE II--VACCINE INJURY COMPENSATION PROGRAM
SEC. 201. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.
Section 2114 of the Public Health Service Act (42 U.S.C. 300aa-14)
is amended--
(1) in subsection (c), by striking paragraph (1) and
inserting the following:
``(1) In promulgating such regulations, the Secretary shall
provide for notice and for at least 9060 days opportunity for
public comment.''; and
(2) in subsection (d), by striking ``90 days'' and
inserting ``60 days''.
SEC. 202. EQUITABLE RELIEF.
Section 2111(a)(2)(A) of the Public Health Service Act (42 U.S.C.
300aa-11(a)(2)(A)) is amended by striking ``No person'' and all that
follows through ``and--'' and inserting the following: ``No person may
bring or maintain a civil action against a vaccine administrator or
manufacturer in a State or Federal court for damages arising from, or
equitable relief relating to, a vaccine-related injury or death
associated with the administration of a vaccine after October 1, 1988
and no such court may award damages or equitable relief for any such
vaccine-related injury or death, unless the person proves past or
present physical injury and a timely petition has been filed, in
accordance with section 2116 for compensation under the Program for
such injury or death and--''.
SEC. 203. PARENT PETITIONS FOR COMPENSATION.
(a) Civil Actions.--Section 2111(a)(2) of the Public Health Service
Act (42 U.S.C. 300aa-(a)(2)) is amended--
(1) in subparagraph (B), by inserting ``or (B)'' after
``subparagraph (A)'';
(2) by redesignating subparagraph (B) as subparagraph (C);
and
(3) by inserting after subparagraph (A) the following:
``(B) No parent or other third party may bring or maintain
a civil action against a vaccine administrator or manufacturer
in a State or Federal court for damages or equitable relief
relating to a vaccine-related injury or death, including but
not limited to damages for loss of consortium, society,
companionship or services, loss of earnings, medical or other
expenses, and emotional distress, and no court may award
damages or equitable relief in such an action unless--
``(i) the person who sustained the underlying
vaccine-related injury or death upon which such parent
or third party's claim is premised has, in accordance
with section 2112, been awarded compensation in a final
judgment of the United States Court of Federal Claims
and such judgment is subject to no further appeal or
review,
``(ii) such parent or other third party is the
parent, legal guardian or spouse of the person who
sustained the underlying vaccine-related injury and
such parent, legal guardian or spouse timely filed a
derivative petition, in accordance with section 2116,
and
``(iii)(I) the United States Court of Federal
Claims has issued judgment under section 2112 on the
derivative petition, and such parent, legal guardian or
spouse elects under section 2121(a) to file a civil
action, or
``(II) such parent, legal guardian or spouse elects
to withdraw such derivative petition under section
2121(b) or such petition is considered withdrawn under
such section.
Any civil action brought in accordance with this subparagraph
shall be subject to the standards and procedures set forth in
section 2122 and 2123, regardless of whether the action arises
directly from a vaccine-related injury or death associated with
the administration of a vaccine. Where the person who sustained
the underlying vaccine-related injury or death upon which such
parent, legal guardian, or spouse's civil cause of action is
premised elects under section 2121(a) to receive the
compensation awarded, such parent or third party may not bring
a civil action for damages or equitable relief, and no court
may award damages or equitable relief, for any injury or loss
of the type set forth in section 2115(a) or that might in any
way overlap with or otherwise duplicate compensation of the
type available under section 2115(a).''.
(b) Applicability.--Section 2111(a)(9) of the Public Health Service
Act (42 U.S.C. 300aa-11(a)(9)) is amended by inserting before the
period the following: ``and to a parent or other third party to the
extent such parent or other third party seeks damages or equitable
relief relating to a vaccine-related injury or death sustained by a
person who is qualified to file a petition for compensation under the
Program''.
(c) Petitioners.--Section 2111(b) of the Public Health Service Act
(42 U.S.C. 300aa-11(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``(B)'' and
inserting ``(C)'';
(B) by redesignating subparagraph (B) as
subparagraph (C); and
(C) by inserting after subparagraph (A) the
following:
``(B) Except as provided in subparagraph (C), any parent,
legal guardian or spouse of a person--
``(i) who has sustained a vaccine-related injury or
death,
``(ii) who has filed a petition for compensation
under the Program (or whose legal representative has
filed a petition as authorized in subparagraph (A)),
and
``(iii) who has, in accordance with section 2112,
been awarded compensation in a final judgment of the
United States Court of Federal Claims that is subject
to no further appeal or review,
may, if such parent, legal guardian or spouse meets the
requirements of subsection (d) of this section, file a
derivative petition under this section.''; and
(2) in paragraph (2)--
(A) by inserting after ``filed'' the following:
``by or on behalf of the person who sustained the
vaccine-related injury or death''; and
(B) by adding at the end the following: ``No
parent, legal guardian, or spouse may file more than
one derivative petition with respect to each
administration of a vaccine.''.
(d) Derivative Petitions.--Section 2111 of the Public Health
Service Act (42 U.S.C. 300aa-11) is amended--
(1) by redesignating subsections (d) and (e) and
subsections (e) and (f), respectively; and
(2) by inserting after subsection (c) the following
subsection:
``(d) Derivative Petitions.--If the parent, legal guardian, or
spouse of the person who sustained the vaccine-related injury or death
seeks compensation under the Program, such parent, legal guardian or
spouse shall file a timely derivative petition for compensation under
the Program in accordance with this section. Such a derivative petition
shall contain--
``(1) an affidavit, and supporting documentation,
demonstrating that--
``(A) the child, ward, or spouse of such person
was, in accordance with section 2112, previously
awarded compensation for the underlying vaccine-related
injury or death upon which such parent's, legal
guardian's, or spouse's derivative claim is premised in
a final judgment of the United States Court of Federal
Claims and such judgment is subject to no further
appeal or review,
``(B) the derivative petition was filed no later
than 60 days after the date on which such judgment
became final and subject to no further appeal or
review,
``(C) such parent, legal guardian or spouse
suffered a loss compensable under section 2115(b) as a
result of the vaccine-related injury or death sustained
by such person's child, ward, or spouse, and
``(D) such parent, legal guardian or spouse has not
previously collected an award or settlement of a civil
action for damages for such loss, and
``(2) records establishing such parent's, legal guardian's,
or spouse's legal relationship to the person who sustained the
vaccine-related injury or death.''.
(e) Determination of Eligibility and Compensation.--Section
2113(a)(1) of the Public Health Service Act (42 U.S.C. 300aa-13(a)(1))
is amended--
(1) in subparagraph (A), by inserting before ``, and'' the
following: ``or, where applicable, section 2111(d)''; and
(2) in subparagraph (B), by inserting before the period the
following: ``or, as applicable, that the injury or loss
described in the derivative petition is due to factors
unrelated to the vaccine-related injury or death''.
(f) Compensation.--Section 2115 of the Public Health Service Act
(42 U.S.C. 300aa-15) is amended--
(1) by redesignating subsections (b) through (j) as
subsections (c) through (k), respectively; and
(2) by inserting after subsection (a) the following:
``(b) Derivative Petitions.--Compensation awarded under the Program
to a parent, legal guardian, or spouse who files a derivative petition
under section 2111 for a loss sustained as a result of a vaccine-
related injury or death sustained by such petitioner's child, ward, or
spouse shall include compensation for loss of consortium, society,
companionship or services, in an amount not to exceed the lesser of
$250,000 or the total amount of compensation awarded to the person who
sustained the underlying vaccine-related injury or death.'';
(3) in subsection (e), by inserting ``, (3), and (4)''
after ``(2)'' and by inserting ``and subsection (b) of this
section,'' following ``section,``;
(4) in subsection (g)(4)(B), by striking ``subsection (j)''
and inserting ``subsection (k)'';
(5) in subsection (j)(1), by striking ``(j)'' and inserting
``(k)'';
(6) in subsection (j)(2), by inserting ``, or to a parent
or spouse of a person who sustained a vaccine-related injury or
death,'' following ``death''; and
(7) in subsection (k), by striking ``subsection (f)(4)(B)''
and inserting ``subsection (g)(4)(B)''.
SEC. 204. JURISDICTION TO DISMISS ACTIONS IMPROPERLY BROUGHT.
Section 2111(a)(3) of the Public Health Service Act (42 U.S.C.
300aa-11(a)(3)) is amended by adding at the end the following: ``If any
civil action which is barred under subparagraph (A) or (B) of paragraph
(2) is filed or maintained in a State court, or any vaccine
administrator or manufacturer is made a party to any civil action
brought in State court (other than a civil action which may be brought
under paragraph (2)) for damages or equitable relief for a vaccine-
related injury or death associated with the administration of a vaccine
after October 1, 1988, the civil action may be removed at any time
before final judgment by the defendant or defendants to the United
States Court of Federal Claims, which shall have jurisdiction over such
civil action, and which shall dismiss such action. The notice required
by section 1446 of title 28, United States Code, shall be filed with
the United States Court of Federal Claims, and that court shall, except
as provided herein, proceed in accordance with sections 1446 through
1451 of title 28, United States Code.''.
SEC. 205. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR UNRELATED TO
ADMINISTRATION OF VACCINE.
Section 2113(a)(2)(B) of the Public Health Service Act (42 U.S.C.
300aa-13(a)(2)(B)) is amended--
(1) by inserting ``structural lesions, genetic disorders,''
after ``and related anoxia)'';
(2) by inserting ``(without regard to whether the cause of
the infection, toxin, trauma, structural lesion, genetic
disorder, or metabolic disturbance is known)'' after
``metabolic disturbances''; and
(3) by striking ``but'' and inserting ``and''.
SEC. 206. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.
Section 2115(a)(3)(B) of the Public Health Service Act (42 U.S.C.
300aa-15(a)(3)(B)) is amended by striking ``loss of earnings'' and all
that follows and inserting the following: ``loss of earnings determined
on the basis of the annual estimate of the average (mean) gross weekly
earnings of wage and salary workers age 18 and over (excluding the
incorporated self-employed) in the private non-farm sector (which
includes all industries other than agricultural production crops and
livestock), as calculated annually by the Bureau of Labor Statistics
from the quarter sample data of the Current Population Survey, or as
calculated by such similar method as the Secretary may prescribe by
regulation, less appropriate taxes and the average cost of a health
insurance policy, as determined by the Secretary.''.
SEC. 207. ALLOWING COMPENSATION FOR FAMILY COUNSELING EXPENSES AND
EXPENSES OF ESTABLISHING GUARDIANSHIP.
(a) Family Counseling Expenses in Post-1988 Cases.--Section 2115(a)
of the Public Health Service Act (42 U.S.C. 300aa-15(a)) is amended by
adding at the end the following:
``(5) Actual unreimbursable expenses that have been or will
be incurred for family counseling as is determined to be
reasonably necessary and that result from the vaccine-related
injury from which the petitioner seeks compensation.''.
(b) Expenses of Establishing Guardianships in Post-1988 Cases.--
Section 2115(a) of the Public Health Service Act (42 U.S.C. 300aa-
15(a)), as amended by subsection (a), is further amended by adding at
the end the following:
``(6) Actual unreimbursable expenses that have been, or
will be reasonably incurred to establish and maintain a
guardianship or conservatorship for an individual who has
suffered a vaccine-related injury, including attorney fees and
other costs incurred in a proceeding to establish and maintain
such guardianship or conservatorship.''.
(c) Conforming Amendment for Cases From 1988 and Earlier.--Section
2115(c) of the Public Health Service Act (42 U.S.C. 300aa-15(c)) is
amended--
(1) in paragraph (2), by striking ``and'' at the end;
(2) in paragraph (3), by inserting a closed parenthesis
before the period in that paragraph, and by striking ``(e)''
and inserting ``(f)'';
(3) by redesignating paragraph (3) as paragraph (5); and
(4) by inserting after paragraph (2), the following:
``(3) family counseling expenses (as provided for in
paragraph (5) of subsection (a));
``(4) expenses of establishing guardianships (as provided
for in paragraph (6) of subsection (a)); and''.
SEC. 208. ALLOWING PAYMENT OF INTERIM COSTS.
Section 2115(f) of the Public Health Service Act (42 U.S.C. 300aa-
15(f)) is amended by adding at the end the following:
``(4) A special master or court may make an interim award of costs
if--
``(A) the case involves a vaccine administered on or after
October 1, 1988;
``(B) the special master or court has determined that the
petitioner is entitled to compensation under the Program;
``(C) the award is limited to other costs (within the
meaning of paragraph (1)(B)) incurred in the proceeding; and
``(D) the petitioner provides documentation verifying the
expenditure of the amount for which compensation is sought.''.
SEC. 209. PROCEDURE FOR PAYING ATTORNEYS' FEES.
Section 2115(f) of the Public Health Service Act (42 U.S.C. 300aa-
15(f)), as amended by section 205, is further amended by adding at the
end the following:
``(5) When a special master or court awards attorney fees or costs
under paragraph (1) or (4), it may order that such fees or costs be
payable solely to the petitioner's attorney if--
``(A) the petitioner expressly consents; or
``(B) the special master or court determines, after
affording to the Secretary and to all interested persons the
opportunity to submit relevant information, that--
``(i) the petitioner cannot be located or refuses
to respond to a request by the special master or court
for information, and there is no practical alternative
means to ensure that the attorney will be reimbursed
for such fees or costs expeditiously; or
``(ii) there are otherwise exceptional
circumstances and good cause for paying such fees or
costs solely to the petitioner's attorney.''.
SEC. 210. EXTENSION OF STATUTE OF LIMITATIONS.
(a) General Rule.--Section 2116(a) of the Public Health Service Act
(42 U.S.C. 300aa-16(a)) is amended--
(1) in paragraph (2) by striking ``36 months'' and
inserting ``6 years''; and
(2) in paragraph (3), by striking ``48 months'' and
inserting ``6 years''.
(b) Effect of Amendment on Previously Untimely Claims.--Section
2121 of the Public Health Service Act (42 U.S.C. 300aa-21) is amended
by adding at the end the following:
``(d) Previously Untimely Claims.--Notwithstanding subsection (a),
(b), or (c) of this section, if a petition is filed under section
2111(a), and such petition would have been untimely under the statute
of limitations set forth in section 2116, as in effect prior to the
effective date of this subsection, the special master shall dismiss the
petition if the special master determines that the petitioner did not
sustain a vaccine-related illness, disability, injury or condition as
listed on the Vaccine Injury Table.''.
(c) Claims Based on Revisions to Table.--Strike all of section
2116(b) of the Public Health Service Act (42 U.S.C. 300aa-16(b)) and
insert the following:
``(b) Effect of Revised Table.--If at any time the Vaccine Injury
Table is revised and the effect of such revision is to make an
individual eligible for compensation under the program, where, before
such revision, such individual was not eligible for compensation under
the program, or to significantly increase the likelihood that an
individual will be able to obtain compensation under the program, such
person may, and must before filing a civil action for equitable relief
or monetary damages, notwithstanding section 2111(b)(2), file a
petition for such compensation if--
``(1) the vaccine-related death or injury with respect to
which the petition is filed occurred not more than 8 years
before the effective date of the revision of the table; and
``(2) either--
``(A) the petition satisfies the conditions
described in subsection (a); or
``(B) the date of the occurrence of the first
symptom or manifestation of onset of the
injury occurred more than 4 years before the petition is filed, and the
petition is filed not more than 2 years after the effective date of the
revision of the table.''.
(d) Derivative Petitions.--Section 2116 of the Public Health
Service Act (42 U.S.C. 300aa-16) is amended by adding at the end the
following:
``(d) Derivative Petitions.--No derivative petition may be filed
for compensation under the Program after the expiration of 60 days
after the date on which the United States Court of Federal Claims has
entered final judgment and the time for all further appeals or review
has expired on the underlying claim of the person who sustained the
vaccine-related injury or death upon which the derivative petition in
premised.''.
(e) Timely Resolutions of Claims.--
(1) Special master decision.--Section 2112(d)(3)(A)(ii) of
the Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(A)(ii))
is amended by adding at the end the following: ``For purposes
of this provision, the petition shall be deemed filed on the
date on which all petition contents and supporting documents
required under section 2111(c) and, when applicable, section
2111(d) and the Vaccine Rules of the United States Court of
Federal Claims, including an affidavit and supporting
documentation, are served on the Secretary and filed with the
clerk of the United States Court of Federal Claims.''.
(2) Court of federal claims decision.--Section 2121(b)(2)
of the Public Health Service Act (42 U.S.C. 300aa-21(b)(2) is
amended by adding at the end the following: ``For purposes of
this provision, the petition shall be deemed filed on the date
on which all petition contents and supporting documents
required under section 2111(c) and, when applicable, section
2111(d) and the Vaccine Rules of the United States Court of
Federal Claims, including an affidavit and supporting
documentation, are served on the Secretary and filed with the
clerk of the United States Court of Federal Claims.''.
SEC. 211. ADVISORY COMMISSION ON CHILDHOOD VACCINES.
(a) Selection of Persons Injured by Vaccines as Public Members.--
Section 2119(a)(1)(B) of the Public Health Service Act (42 U.S.C.
300aa-19(a)(1)(B)) is amended by striking ``of whom'' and all that
follows and inserting the following: ``of whom 1 shall be the legal
representative of a child who has suffered a vaccine-related injury or
death, and at least 1 other shall be either the legal representative of
a child who has suffered a vaccine-related injury or death or an
individual who has personally suffered a vaccine-related injury.''.
(b) Mandatory Meeting Schedule Eliminated.--Section 2119(c) of the
Public Health Service Act (42 U.S.C. 300aa-19(c)) is amended by
striking ``not less often than four times per year and''.
SEC. 212. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.
(a) General Rule.--Section 2122(a) of the Public Health Service Act
(42 U.S.C. 300aa-22(a)) is amended by striking ``and (e) State law
shall apply to a civil action brought for damages'' and inserting
``(d), and (f) State law shall apply to a civil action brought for
damages or equitable relief''; and
(b) Unavoidable Adverse Side Effects.--Section 2122(b)(1) of the
Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) is amended by
inserting ``or equitable relief'' after ``for damages''.
(c) Direct Warnings.--Section 2122(c) of the Public Health Service
Act (42 U.S.C. 300aa-22(c)) is amended by inserting ``or equitable
relief'' after ``for damages''.
(d) Construction.--Section 2122(d) of the Public Health Service Act
(42 U.S.C. 300aa-22(d)) is amended--
(1) by inserting ``or equitable relief'' after ``for
damages''; and
(2) by inserting ``or relief'' after ``which damages''.
(e) Present Physical Injury.--Section 2122 of the Public Health
Service Act (42 U.S.C. 300aa-22) is amended--
(1) by redesignating subsections (d) and (e) as subsections
(e) and (f), respectively; and
(2) by inserting after subsection (c) the following:
``(d) Present Physical Injury.--No vaccine manufacturer or vaccine
administrator shall be liable in a civil action brought after October
1, 1988, for equitable or monetary relief absent proof of past or
present physical injury from the administration of a vaccine, nor shall
any vaccine manufacturer or vaccine administrator be liable in any such
civil action for claims of medical monitoring, or increased risk of
harm.''.
SEC. 213. CLARIFICATION OF DEFINITION OF MANUFACTURER.
Section 2133(3) of the Public Health Service Act (42 U.S.C. 300aa-
33(3)) is amended--
(1) in the first sentence, by striking ``under its label
any vaccine set forth in the Vaccine Injury Table'' and
inserting ``any vaccine set forth in the Vaccine Injury table,
including any component or ingredient of any such vaccine''; and
(2) in the second sentence, by inserting ``including any
component or ingredient of any such vaccine'' before the
period.
SEC. 214. CLARIFICATION OF DEFINITION OF VACCINE-RELATED INJURY OR
DEATH.
Section 2133(5) of the Public Health Service Act (42 U.S.C. 300aa-
33(5)) is amended by adding at the end the following: ``For purposes of
the preceding sentence, an adulterant or contaminant shall not include
any component or ingredient listed in a vaccine's product license
application or product label.''.
SEC. 215. CLARIFICATION OF DEFINITION OF VACCINE.
Section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33)
is amended by adding at the end the following:
``(7) The term `vaccine' means any preparation or suspension,
including but not limited to a preparation or suspension containing an
attenuated or inactive microorganism or subunit thereof or toxin,
developed or administered to produce or enhance the body's immune
response to a disease or diseases and includes all components and
ingredients listed in the vaccines's product license application and
product label.''.
SEC. 216. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.
Part C of title XXI of the Public Health Service Act (42 U.S.C.
300a-25 et seq.) is amended by adding at the end the following:
``SEC. 2129. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.
``(a) In General.--Not later than 6 months after the date of
enactment of this section, the Secretary shall enter into a contract
with the Institute of Medicine of the National Academy of Science under
which the Institute shall conduct an ongoing, comprehensive review of
new scientific data on childhood vaccines (according to priorities
agreed upon from time to time by the Secretary and the Institute of
Medicine).
``(b) Reports.--Not later than 3 years after the date on which the
contract is entered into under paragraph (1), the Institute of Medicine
shall submit to the Secretary a report on the findings of studies
conducted, including findings as to any adverse events associated with
childhood vaccines, including conclusions concerning causation of
adverse events by such vaccines and other appropriate recommendations,
based on such findings and conclusions.
``(c) Failure To Enter Into Contract.--If the Secretary and the
Institute of Medicine are unable to enter into the contract described
in paragraph (1), the Secretary shall enter into a contract with
another qualified nongovernmental scientific organization for the
purposes described in paragraphs (1) and (2).
``(d) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated such sums as may be necessary
for each of fiscal years 2003, 2004, 2005 and 2006.''.
SEC. 217. PENDING ACTIONS.
The amendments made by this title shall apply to all actions or
proceedings pending on or after the date of enactment of this Act
unless a court of competent jurisdiction has entered judgment
(regardless of whether the time for appeal has expired) in such action
or proceeding disposing of the entire action or proceeding.
SEC. 218. REPORT.
Not later than 1 year after the date of enactment of this Act, and
annually thereafter, the Advisory Commission on Childhood Vaccines
shall report to the Secretary of Health and Human Services regarding
the status of the Vaccine Trust Fund, and shall make recommendations to
the Secretary regarding the allocation of disbursements from the Fund.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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