HIV Organ Policy Equity Act

Summary: (This measure has not been amended since it was passed by the Senate on June 17, 2013.  HIV Organ Policy Equity Act - Amends the Public Health Service Act to repeal the requirement that the Organ Procurement and Transplantation Network adopt and use standards of quality for the acquisition and transportation of donated organs that include standards for preventing the acquisition of organs infected with the etiologic agent for acquired immune deficiency syndrome (AIDS). Replaces this requirement with authorization for the Network to adopt and use such standards with respect to organs infected with human immunodeficiency virus (HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who are: (1) infected with such virus before receiving such an organ; and (2) participating in clinical research approved by an institutional review board under the criteria, standards, and regulations regarding organs infected with HIV developed under this Act or, if participation in such research is no longer warranted, receiving a transplant under such standards and regulations. Revises similarly the requirement that organ procurement organizations arrange for testing to prevent the acquisition of organs infected with the AIDS etiologic agent to require that they arrange for testing to identify organs infected with HIV. Directs the Secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors. Requires the Network to revise its standards of quality regarding HIV-infected organs and the Secretary to revise related regulations. Requires the Secretary to: (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of transplantation of organs with a particular strain of HIV into a recipient with a different strain; and (2) direct the Network, if the review so warrants, to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation. Amends the federal criminal code to declare that an organ donation does not violate the prohibition against a knowing organ donation by an HIV-infected individual if the donation is made in accordance with this Act.

SECTION 1. SHORT TITLE.
    This Act may be cited as the ``HIV Organ Policy Equity Act''.
SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
    (a) Standards of Quality for the Acquisition and Transportation of 
Donated Organs.--
        (1) Organ procurement and transplantation network.--Section 
    372(b) of the Public Health Service Act (42 U.S.C. 274(b)) is 
    amended--
            (A) in paragraph (2)(E), by striking ``, including 
        standards for preventing the acquisition of organs that are 
        infected with the etiologic agent for acquired immune 
        deficiency syndrome''; and
            (B) by adding at the end the following:
        ``(3) Clarification.--In adopting and using standards of 
    quality under paragraph (2)(E), the Organ Procurement and 
    Transplantation Network may adopt and use such standards with 
    respect to organs infected with human immunodeficiency virus (in 
    this paragraph referred to as `HIV'), provided that any such 
    standards ensure that organs infected with HIV may be transplanted 
    only into individuals who--
            ``(A) are infected with HIV before receiving such organ; 
        and
            ``(B)(i) are participating in clinical research approved by 
        an institutional review board under the criteria, standards, 
        and regulations described in subsections (a) and (b) of section 
        377E; or
            ``(ii) if the Secretary has determined under section 
        377E(c) that participation in such clinical research, as a 
        requirement for such transplants, is no longer warranted, are 
        receiving a transplant under the standards and regulations 
        under section 377E(c).''.
        (2) Conforming amendment.--Section 371(b)(3)(C) of the Public 
    Health Service Act (42 U.S.C. 273(b)(3)(C); relating to organ 
    procurement organizations) is amended by striking ``including 
    arranging for testing with respect to preventing the acquisition of 
    organs that are infected with the etiologic agent for acquired 
    immune deficiency syndrome'' and inserting ``including arranging 
    for testing with respect to identifying organs that are infected 
    with human immunodeficiency virus (HIV)''.
        (3) Technical amendments.--Section 371(b)(1) of the Public 
    Health Service Act (42 U.S.C. 273(b)(1)) is amended by--
            (A) striking subparagraph (E);
            (B) redesignating subparagraphs (F) and (G) as 
        subparagraphs (E) and (F), respectively;
            (C) striking ``(H) has a director'' and inserting ``(G) has 
        a director''; and
            (D) in subparagraph (H)--
                (i) in clause (i) (V), by striking ``paragraph (2)(G)'' 
            and inserting ``paragraph (3)(G)''; and
                (ii) in clause (ii), by striking ``paragraph (2)'' and 
            inserting ``paragraph (3)''.
    (b) Publication of Research Guidelines.--Part H of title III of the 
Public Health Service Act (42 U.S.C. 273 et seq.) is amended by 
inserting after section 377D the following:
``SEC. 377E. CRITERIA, STANDARDS, AND REGULATIONS WITH RESPECT TO 
ORGANS INFECTED WITH HIV.
    ``(a) In General.--Not later than 2 years after the date of the 
enactment of the HIV Organ Policy Equity Act, the Secretary shall 
develop and publish criteria for the conduct of research relating to 
transplantation of organs from donors infected with human 
immunodeficiency virus (in this section referred to as `HIV') into 
individuals who are infected with HIV before receiving such organ.
    ``(b) Corresponding Changes to Standards and Regulations Applicable 
to Research.--Not later than 2 years after the date of the enactment of 
the HIV Organ Policy Equity Act, to the extent determined by the 
Secretary to be necessary to allow the conduct of research in 
accordance with the criteria developed under subsection (a)--
        ``(1) the Organ Procurement and Transplantation Network shall 
    revise the standards of quality adopted under section 372(b)(2)(E); 
    and
        ``(2) the Secretary shall revise section 121.6 of title 42, 
    Code of Federal Regulations (or any successor regulations).
    ``(c) Revision of Standards and Regulations Generally.--Not later 
than 4 years after the date of the enactment of the HIV Organ Policy 
Equity Act, and annually thereafter, the Secretary, shall--
        ``(1) review the results of scientific research in conjunction 
    with the Organ Procurement and Transplantation Network to determine 
    whether the results warrant revision of the standards of quality 
    adopted under section 372(b)(2)(E) with respect to donated organs 
    infected with HIV and with respect to the safety of transplanting 
    an organ with a particular strain of HIV into a recipient with a 
    different strain of HIV;
        ``(2) if the Secretary determines under paragraph (1) that such 
    results warrant revision of the standards of quality adopted under 
    section 372(b)(2)(E) with respect to donated organs infected with 
    HIV and with respect to transplanting an organ with a particular 
    strain of HIV into a recipient with a different strain of HIV, 
    direct the Organ Procurement and Transplantation Network to revise 
    such standards, consistent with section 372 and in a way that 
    ensures the changes will not reduce the safety of organ 
    transplantation; and
        ``(3) in conjunction with any revision of such standards under 
    paragraph (2), revise section 121.6 of title 42, Code of Federal 
    Regulations (or any successor regulations).''.
SEC. 3. CONFORMING AMENDMENT TO TITLE 18 OF THE UNITED STATES CODE.
    Section 1122(a) of title 18, United States Code, is amended by 
inserting ``or in accordance with all applicable guidelines and 
regulations made by the Secretary of Health and Human Services under 
section 377E of the Public Health Service Act'' after ``research or 
testing''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.