Success-The Hope Act-HIV Organ Policy Equity Act-S. 330

HIV Organ Policy Equity Act

The goal of our advocacy and our desire to help show our support for the original bills was to actually overturn a federal ban on organ transplants from HIV-positive donors to HIV-positive recipients. Previously, as per a 1988 amendment to federal law (PL 98-507) regarding organ transplants, performing transplants among HIV positive people was prohibited.

The original bill aimed to increase the availability of up to 500 or high quality organs for HIV-positive patients each year. Those deceased donor organs would have otherwise been discarded.

This bill was enacted after being signed by the President on November 21, 2013. The text of the bill below is as of Nov 14, 2013

One Hundred Thirteenth Congress of the United States of America

1st Session

Begun and held at the City of Washington on Thursday, the third day of January, two thousand and thirteen

S. 330

AN ACT

To amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV).

1.Short title
This Act may be cited as the HIV Organ Policy Equity Act.

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 insertingparagraph (3)(G); and
(ii)in clause (ii), by striking paragraph (2) and insertingparagraph (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:

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).
.

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