Health and Human Services issued a final rule today lifting the ban on organ donation from HIV-positive individuals.
Organ from infected donors will only be allowed for implantation in HIV-positive recipients, and only under clinical trials until the secretary makes a determination otherwise.
The rule takes effect June 8 and is the result of legislation passed in 2013. The HIV Organ Policy Equity (HOPE) Act was introduced by Sens. Tammy Baldwin (D-Wis.), Barbara Boxer (D-Calif.), Rand Paul (R-Ky.) and Tom Coburn (R-Okla.).
“Today’s news reflects the significant progress we are making in medicine and medical research, as well as in breaking down the stigma associated with HIV/AIDS,” Baldwin said today. “I am proud to have worked across party lines on this important issue. The HOPE Act is not only a commonsense step forward in saving countless lives, but also decreasing the organ wait time and reducing health care costs in the long term.”
The HHS study will focus on the safety and effectiveness of HIV-positive to HIV-positive organ donation.
“If and when the Secretary determines that participation in such clinical research should no longer be a requirement for transplants with organs from donors infected with HIV to individuals infected with HIV, the regulation mandates that the [Organ Procurement and Transplantation Network] adopt and use standards of quality, as directed by the Secretary, consistent with the law and in a way that ensures the changes will not reduce the safety of organ transplantation,” states the rule in the Federal Register.
The rule predicts “the number of HIV-infected transplants, and the number of institutions performing HIV-infected transplants, will be small.”
The agency skipped notice and public comment, calling it “unnecessary and impracticable to follow proposed rulemaking procedures in this instance.”
“Thus, the Secretary is waiving the public notice and comment procedures in the interest of implementing the changes set forth in the HOPE Act, to enable persons infected with HIV to receive organs from individuals infected with HIV as long as all of the requirements set forth in the HOPE Act are satisfied and to enable the OPTN to revise its standards of quality, consistent with the HOPE Act.”