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(Public Law 109-148)) is repealed.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.
`(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).
`(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';
(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--
`(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.';
(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
(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;
`(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
END
