Regulatory Focus™ > News Articles > HHS Establishes Organ Donation Policy for Patients With HIV

HHS Establishes Organ Donation Policy for Patients With HIV

Posted 08 May 2015 | By Alexander Gaffney, RAC 

HHS Establishes Organ Donation Policy for Patients With HIV

The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV).

Background

The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013.

The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-positive individuals to donate organs to HIV-positive recipients. Under the 1984 law, it was illegal for any HIV-positive organ to be donated or received.

"As our understanding of HIV and effective treatments have grown, that policy has become outdated," Obama said in a statement.

Under the HOPE Act, HHS was directed to set up what were essentially two parallel systems of organ donation: one for patients and donors without HIV, and another for patients and donors with HIV.

While the legislation envisioned a policy under which organs could only be donated to HIV-positive individuals if they were participating in clinical research approved by an institutional review board, HHS was given the option of waiving this requirement if the department believed it was "no longer warranted."

HHS: Clinical Trial Restrictions Still Apply

According to its new regulation, however, HHS believes such restrictions are still warranted.

"This regulation includes new requirements that organs from individuals infected with HIV may be transplanted only into individuals who are infected with HIV before receiving such organs and who are participating in clinical research approved by an institutional review board, as provided by regulation," HHS wrote.

"Although the HOPE Act also provides the Secretary with discretion to determine what criteria should apply to the conduct of such research, the Secretary is not promulgating such research criteria as part of this regulation."

The agency did note in its Federal Register notice that it may revisit the issue at a later date.

Text of Regulation

The complete text of the regulation may be found below:

§ 121.6 Organ procurement.

(b) HIV

(1) Organs from individuals infected with human immunodeficiency virus (HIV) may be transplanted only into individuals who—

(i) Are infected with HIV before receiving such organ(s); and

(ii)(A) Are participating in clinical research approved by an institutional review board, as defined in 45 CFR part 46, under the research criteria published by the Secretary under subsection (a) of section 377E of the Public Health Service Act, as amended; or

(B) The Secretary has published, through appropriate procedures, a determination under section 377E(c) of the Public Health Service Act, as amended, that participation in such clinical research, as a requirement for transplants of organs from individuals infected with HIV, is no longer warranted.

(2) Except as provided in paragraph (b)(3) of this section, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV to the extent the Secretary determines necessary to allow the conduct of research in accordance with the criteria described in paragraph (b)(1)(ii)(A) of this section.

(3) If the Secretary has determined under paragraph (b)(1)(ii)(B) of this section that participation in clinical research is no longer warranted as a requirement for transplants of organs from individuals infected with HIV, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV as directed by the Secretary, consistent with 42 U.S.C. 274, and in a way that ensures the changes will not reduce the safety of organ transplantation.

 

Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act


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