`[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Pandemic Influenza Act, 2006 (Public Law 109-148)) is repealed.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`