Responsible Public Readiness and Emergency Preparedness Act - Repeals the Public Readiness and Emergency Preparedness Act (Division C of the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006).
Amends the Public Health Service Act to establish the Biodefense Injury Compensation Program to provide compensation for death or any injury, illness, disability, or condition that is likely to have been caused by the administration of a covered countermeasure pursuant to a declaration by the Secretary of Health and Human Services that an actual or potential bioterrorist incident or public health emergency makes such administration to a category of individuals advisable.
Requires the Secretary: (1) after making such a declaration, to enter into a contract for the Institute of Medicine to provide its recommendations on the injuries, disabilities, illnesses, and conditions likely to have been caused by the countermeasure; and (2) after receiving such recommendations, to specify those injuries, disabilities, illnesses, and conditions deemed to be included in the Vaccine Injury Table.
Sets the effective date for such Program as November 25, 2002.
Extends liability protection for health professionals administering small pox countermeasures to covered countermeasures under this Act. Excludes from such protection the administration by a qualified person of a covered countermeasure to an individual who was not within a category of individuals covered by the declaration where such qualified person did not have reasonable grounds to believe such individual was within such a category.
Makes the United States liable for any claims arising out of the manufacture, distribution, or administration of a covered countermeasure, including claims brought by U.S. military personnel.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3983 Placed on Calendar Senate (PCS)]
Calendar No. 658
109th CONGRESS
2d Session
S. 3983
To amend the Public Health Service Act to provide assured compensation
for first responders injured by experimental vaccines and drugs and to
indemnify manufacturers and health care professionals for the
administration of medical products needed for biodefense.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 28, 2006
Mr. Kennedy introduced the following bill; which was read the first
time
September 30 (legislative day, September 29), 2006
Read the second time and placed on the calendar
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide assured compensation
for first responders injured by experimental vaccines and drugs and to
indemnify manufacturers and health care professionals for the
administration of medical products needed for biodefense.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Responsible Public Readiness and
Emergency Preparedness Act''.
SEC. 2. ASSURED COMPENSATION FOR FIRST RESPONDERS INJURED BY
EXPERIMENTAL VACCINES AND DRUGS.
(a) Repeal.--The Public Readiness and Emergency Preparedness Act
(division C of the Department of Defense, Emergency Supplemental
Appropriations to Address Hurricanes in the Gulf of Mexico, and
Pandemic Influenza Act, 2006 (Public Law 109-148)) is repealed.
(b) National Biodefense Injury Compensation Program.--
(1) Establishment.--Section 224 of the Public Health
Service Act (42 U.S.C. 233) is amended by adding at the end the
following:
``(q) Biodefense Injury Compensation Program.--
``(1) Establishment.--There is established the Biodefense
Injury Compensation Program (referred to in this subsection as
the `Compensation Program') under which compensation may be
paid for death or any injury, illness, disability, or condition
that is likely (based on best available evidence) to have been
caused by the administration of a covered countermeasure to an
individual pursuant to a declaration under subsection (p)(2).
``(2) Administration and interpretation.--The statutory
provisions governing the Compensation Program shall be
administered and interpreted in consideration of the program
goals described in paragraph (4)(B)(iii).
``(3) Procedures and standards.--The Secretary shall by
regulation establish procedures and standards applicable to the
Compensation Program that follow the procedures and standards
applicable under the National Vaccine Injury Compensation
Program established under section 2110, except that the
regulations promulgated under this paragraph shall permit a
person claiming injury or death related to the administration
of any covered countermeasure to file either--
``(A) a civil action for relief under subsection
(p); or
``(B) a petition for compensation under this
subsection.
``(4) Injury table.--
``(A) Inclusion.--For purposes of receiving
compensation under the Compensation Program with
respect to a countermeasure that is the subject of a
declaration under subsection (p)(2), the Vaccine Injury
Table under section 2114 shall be deemed to include
death and the injuries, disabilities, illnesses, and
conditions specified by the Secretary under
subparagraph (B)(ii).
``(B) Injuries, disabilities, illnesses, and
conditions.--
``(i) Institute of medicine.--Not later
than 30 days after making a declaration
described in subsection (p)(2), the Secretary
shall enter into a contract with the Institute
of Medicine, under which the Institute shall,
within 180 days of the date on which the
contract is entered into, and periodically
thereafter as new information, including
information derived from the monitoring of
those who were administered the countermeasure,
becomes available, provide its expert
recommendations on the injuries, disabilities,
illnesses, and conditions whose occurrence in
one or more individuals are likely (based on
best available evidence) to have been caused by
the administration of a countermeasure that is
the subject of the declaration.
``(ii) Specification by secretary.--Not
later than 30 days after the receipt of the
expert recommendations described in clause (i),
the Secretary shall, based on such
recommendations, specify those injuries,
disabilities, illnesses, and conditions deemed
to be included in the Vaccine Injury Table
under section 2114 for the purposes described
in subparagraph (A).
``(iii) Program goals.--The Institute of
Medicine, under the contract under clause (i),
shall make such recommendations, the Secretary
shall specify, under clause (ii), such
injuries, disabilities, illnesses, and
conditions, and claims under the Compensation
Program under this subsection shall be
processed and decided taking into account the
following goals of such program:
``(I) To encourage persons to
develop, manufacture, and distribute
countermeasures, and to administer
covered countermeasures to individuals,
by limiting such persons' liability for
damages related to death and such
injuries, disabilities, illnesses, and
conditions.
``(II) To encourage individuals to
consent to the administration of a
covered countermeasure by providing
adequate and just compensation for
damages related to death and such
injuries, disabilities, illnesses, or
conditions.
``(III) To provide individuals
seeking compensation for damages
related to the administration of a
countermeasure with a non-adversarial
administrative process for obtaining
adequate and just compensation.
``(iv) Use of best available evidence.--The
Institute of Medicine, under the contract under
clause (i), shall make such recommendations,
the Secretary shall specify, under clause (ii),
such injuries, disabilities, illnesses, and
conditions, and claims under the Compensation
Program under this subsection shall be
processed and decided using the best available
evidence, including information from adverse
event reporting or other monitoring of those
individuals who were administered the
countermeasure, whether evidence from clinical
trials or other scientific studies in humans is
available.
``(v) Application of section 2115.--With
respect to section 2115(a)(2) as applied for
purposes of this subsection, an award for the
estate of the deceased shall be--
``(I) if the deceased was under the
age of 18, an amount equal to the
amount that may be paid to a survivor
or survivors as death benefits under
the Public Safety Officers' Benefits
Program under subpart 1 of part L of
title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C.
3796 et seq.); or
``(II) if the deceased was 18 years
of age or older, the greater of--
``(aa) the amount described
in subclause (I); or
``(bb) the projected loss
of employment income, except
that the amount under this item
may not exceed an amount equal
to 400 percent of the amount
that applies under item (aa).
``(vi) Application of section 2116.--
Section 2116(b) shall apply to injuries,
disabilities, illnesses, and conditions
initially specified or revised by the Secretary
under clause (ii), except that the exceptions
contained in paragraphs (1) and (2) of such
section shall not apply.
``(C) Rule of construction.--Section 13632 (a)(3)
of Public Law 103-66 (107 Stat. 646) (making revisions
by Secretary to the Vaccine Injury Table effective on
the effective date of a corresponding tax) shall not be
construed to apply to any revision to the Vaccine
Injury Table made under regulations under this
paragraph.
``(5) Application.--The Compensation Program applies to any
death or injury, illness, disability, or condition that is
likely (based on best available evidence) to have been caused
by the administration of a covered countermeasure to an
individual pursuant to a declaration under subsection (p)(2).
``(6) Special masters.--
``(A) Hiring.--In accordance with section 2112, the
judges of the United States Claims Court shall appoint
a sufficient number of special masters to address
claims for compensation under this subsection.
``(B) Budget authority.--There are appropriated to
carry out this subsection such sums as may be necessary
for fiscal year 2006 and each fiscal year thereafter.
This subparagraph constitutes budget authority in
advance of appropriations and represents the obligation
of the Federal Government.
``(7) Covered countermeasure.--For purposes of this
subsection, the term `covered countermeasure' has the meaning
given to such term in subsection (p)(7)(A).
``(8) Funding.--Compensation made under the Compensation
Program shall be made from the same source of funds as payments
made under subsection (p).''.
(2) Effective date.--This subsection shall take effect as
of November 25, 2002 (the date of enactment of the Homeland
Security Act of 2002 (Public Law 107-296; 116 Stat. 2135)).
SEC. 3. INDEMNIFICATION FOR MANUFACTURERS AND HEALTH CARE PROFESSIONALS
WHO ADMINISTER MEDICAL PRODUCTS NEEDED FOR BIODEFENSE.
Section 224(p) of the Public Health Service Act (42 U.S.C. 233(p))
is amended--
(1) in the subsection heading by striking ``Smallpox'';
(2) in paragraph (1), by striking ``against smallpox'';
(3) in paragraph (2)--
(A) in the paragraph heading, by striking ``against
smallpox''; and
(B) in subparagraph (B), by striking clause (ii);
(4) by striking paragraph (3) and inserting the following:
``(3) Exclusivity; offset.--
``(A) Exclusivity.--With respect to an individual
to which this subsection applies, such individual may
bring a claim for relief under--
``(i) this subsection;
``(ii) subsection (q); or
``(iii) part C.
``(B) Election of alternatives.--An individual may
only pursue one remedy under subparagraph (A) at any
one time based on the same incident or series of
incidents. An individual who elects to pursue the
remedy under subsection (q) or part C may decline any
compensation awarded with respect to such remedy and
subsequently pursue the remedy provided for under this
subsection. An individual who elects to pursue the
remedy provided for under this subsection may not
subsequently pursue the remedy provided for under
subsection (q) or part C.
``(C) Statute of limitations.--For purposes of
determining how much time has lapsed when applying
statute of limitations requirements relating to
remedies under subparagraph (A), any limitation of time
for commencing an action, or filing an application,
petition, or claim for such remedies, shall be deemed
to have been suspended for the periods during which an
individual pursues a remedy under such subparagraph.
``(D) Offset.--The value of all compensation and
benefits provided under subsection (q) or part C of
this title for an incident or series of incidents shall
be offset against the amount of an award, compromise,
or settlement of money damages in a claim or suit under
this subsection based on the same incident or series of
incidents.'';
(5) in paragraph (6)--
(A) in subparagraph (A), by inserting ``or under
subsection (q) or part C'' after ``under this
subsection''; and
(B) by redesignating subparagraph (B) as
subparagraph (C);
(C) by inserting after subparagraph (A), the
following:
``(B) Grossly negligent, reckless, or illegal
conduct and willful misconduct.--For purposes of
subparagraph (A), grossly negligent, reckless, or
illegal conduct or willful misconduct shall include the
administration by a qualified person of a covered
countermeasure to an individual who was not within a
category of individuals covered by a declaration under
subsection (p)(2) with respect to such countermeasure
where the qualified person fails to have had reasonable
grounds to believe such individual was within such a
category.''; and
(D) by adding at the end the following:
``(D) Liability of the united states.--The United
States shall be liable under this subsection with
respect to a claim arising out of the manufacture,
distribution, or administration of a covered
countermeasure regardless of whether--
``(i) the cause of action seeking
compensation is alleged as negligence, strict
liability, breach of warranty, failure to warn,
or other action; or
``(ii) the covered countermeasure is
designated as a qualified anti-terrorism
technology under the SAFETY Act (6 U.S.C. 441
et seq.).
``(E) Governing law.--Notwithstanding the
provisions of section 1346(b)(1) and chapter 171 of
title 28, United States Code, as they relate to
governing law, the liability of the United States as
provided in this subsection shall be in accordance with
the law of the place of injury.
``(F) Military personnel and united states citizens
overseas.--
``(i) Military personnel.--The liability of
the United States as provided in this
subsection shall extend to claims brought by
United States military personnel.
``(ii) Claims arising in a foreign
country.--Notwithstanding the provisions of
section 2680(k) of title 28, United States
Code, the liability of the United States as
provided for in the subsection shall extend to
claims based on injuries arising in a foreign
country where the injured party is a member of
the United States military, is the spouse or
child of a member of the United States
military, or is a United States citizen.
``(iii) Governing law.--With regard to all
claims brought under clause (ii), and
notwithstanding the provisions of section
1346(b)(1) and chapter 171 of title 28, United
States Code, and of subparagraph (C), as they
relate to governing law, the liability of the
United States as provided in this subsection
shall be in accordance with the law of the
claimant's domicile in the United States or
most recent domicile with the United States.'';
and
(6) in paragraph (7)--
(A) by striking subparagraph (A) and inserting the
following:
``(A) Covered countermeasure.--The term `covered
countermeasure', means--
``(i) a substance that is--
``(I)(aa) used to prevent or treat
smallpox (including the vaccinia or
another vaccine); or
``(bb) vaccinia immune globulin
used to control or treat the adverse
effects of vaccinia inoculation; and
``(II) specified in a declaration
under paragraph (2); or
``(ii) a drug (as such term is defined in
section 201(g)(1) of the Federal Food, Drug,
and Cosmetic Act), biological product (as such
term is defined in section 351(i) of this Act),
or device (as such term is defined in section
201(h) of the Federal Food, Drug, and Cosmetic
Act) that--
``(I) the Secretary determines to
be a priority (consistent with sections
302(2) and 304(a) of the Homeland
Security Act of 2002) to treat,
identify, or prevent harm from any
biological, chemical, radiological, or
nuclear agent identified as a material
threat under section 319F-
2(c)(2)(A)(ii), or to treat, identify,
or prevent harm from a condition that
may result in adverse health
consequences or death and may be caused
by administering a drug, biological
product, or device against such an
agent;
``(II) is--
``(aa) authorized for
emergency use under section 564
of the Federal Food, Drug, and
Cosmetic Act, so long as the
manufacturer of such drug,
biological product, or device
has--
``(AA) made all reasonable
efforts to obtain applicable
approval, clearance, or
licensure; and
``(BB) cooperated fully
with the requirements of the
Secretary under such section
564; or
``(bb) approved or licensed
solely pursuant to the
regulations under subpart I of
part 314 or under subpart H of
part 601 of title 21, Code of
Federal Regulations (as in
effect on the date of enactment
of the National Biodefense Act
of 2005); and
``(III) is specified in a
declaration under paragraph (2).''; and
(B) in subparagraph (B)--
(i) by striking clause (ii), and inserting
the following:
``(ii) a health care entity, a State, or a
political subdivision of a State under whose
auspices such countermeasure was
administered;''and
(ii) in clause (viii), by inserting before
the period ``if such individual performs a
function for which a person described in clause
(i), (ii), or (iv) is a covered person''.
Calendar No. 658
109th CONGRESS
2d Session
S. 3983
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide assured compensation
for first responders injured by experimental vaccines and drugs and to
indemnify manufacturers and health care professionals for the
administration of medical products needed for biodefense.
_______________________________________________________________________
September 30 (legislative day, September 29), 2006
Read the second time and placed on the calendar
Introduced in Senate
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 658.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line