Hello ACBTSA Members:
Treatment Action Group (TAG) is submitting this public comment in response to the request for comment to inform ACBTSA’s (hereafter “the Committee”) upcoming November 17, 2022 discussion and voting on the recommendation related to implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, specifically pertaining to HIV-positive to HIV-positive organ transplantation and pertaining to the following draft recommendation under consideration regarding removal of the statutory “NIH Research Criteria and IRB” requirement. (Read the draft recommendation.)
Founded in 1992, TAG is an independent, activist, and community-based research and policy think tank comprised of a team of science-based activists working to expand and accelerate vital research and effective community engagement for an end to the HIV, tuberculosis (TB), and hepatitis C (HCV) pandemics. TAG catalyzes open collective action by affected communities, scientists, and policymakers to ensure that all affected communities — especially communities of color and other marginalized communities — receive life-saving prevention, diagnosis, treatment, care, and information.
In accordance with TAG’s mission of promoting universal and equitable access to opportunities to participate in research and the benefits of products stemming from biomedical research, we were among numerous HIV advocacy and policy organizations that championed repeal of the prior federal ban on transplanting organs from HIV+ donors to benefit HIV+ recipients, and we endorsed passage and adoption into law of the HOPE Act statute (Public Law No: 113-51) — which represented a groundbreaking and long-overdue effort to expand access to organ donations and transplantation for people living with HIV (PLWH). We believe that reducing all barriers to the transplantation of organs from, between, and to people living with HIV constitutes a commitment to Right to Science — a framework through which it is recognized that “States as duty bearers are obligated to ensure that everyone can share in the benefits of scientific advancement” (https://www.treatmentactiongroup.org/wp-content/uploads/2022/02/tag_ohchr_submission_resolution_47_17.pdf).
Without a doubt, the ability of PLWH to donate and receive organs from other PLWH represents such a benefit of scientific advancement; and now in 2022, nearly a decade since passage of the HOPE Act, there is no justifiable reason not to maximize federal, state and local investments in expansion of this benefit beyond the statutory “NIH Research Criteria and IRB” requirement through which PLWH are currently able to participate as donors in the HIV-to-HIV organ transplantation process. To maintain the current research designation over PLWH’s participation in the organ donation process only further undermines an already proven effective intervention that to-date far too many people remain unaware is even possible — including PLWH who serve to benefit the most from either knowing that designation as a living and/or deceased organ donor is available or knowing that receipt of an organ donated by another person with HIV is an option in the event they should find themselves diagnosed with end-stage organ disease . As we noted in 2004 regarding the harmful impacts of organ shortages on PLWH: “We must increase educational initiatives on the urgency of the organ shortage in the United States. Conversations about organ donation should become a routine part of health education and medical care…” (https://www.treatmentactiongroup.org/publication/chronic-shortage-of-donor-organs-threatens-people-with-hiv-2004). This rings true even today, nearly a decade after initial passage of the HOPE Act. In combination with robust education campaigns and community engagement programs that are geared toward medical providers, people living with HIV and the general population, removal of the research requirement from the HIV-to-HIV organ donation intervention will undeniably allow for more transparent and medically accurate communication between patients, their families and providers regarding their health care options.
Despite a steady increase in the number of kidney and liver transplants performed among PLWH and the fact solid organ transplantation has become the treatment of choice for organ failure among this population, we are dismayed at low awareness of the HOPE Act’s stipulations, persistent challenges in regards to its implementation, and slow expansion of the ability of PLWH who are in need of donated organs to access its benefits. HIV stigma and low donor registration rates pose barriers to expanded awareness and access to benefits of the HOPE Act. So, too, do systemic barriers (e.g., inefficient protocols and suboptimal community engagement activities) and structural barriers (e.g., laws that criminalize organ donation by PLWH). It is imperative that we address systemic and structural barriers in order to ensure more efficient, equitable access to organ donation for PLWH. Removing the research designation over organ transplantations made possible by the HOPE Act has the potential to dramatically further transform the landscape of health equity for PLWH by combating structural HIV stigma, while concomitantly reducing inequities for racial and ethnic minoritized populations who are disproportionately affected by HIV and other chronic illnesses that imperil organ longevity in the first place.
In 2022, it is unacceptable that any person living with HIV who wishes to become a live and/or deceased donor is unaware of their ability to do so. It is also unconscionable for any PLWH who needs to receive an organ donation to be denied this medical intervention due to suboptimal education about their options or due to organ waste resulting from barriers presented by the statutory research designation. As Nina Martinez, an organ transplantation and HIV advocate, and the first PLWH living kidney donor has poignantly noted, also in response to this request for public comment: “All transplant candidates benefit when people living with HIV are transplanted because active HIV-to-HIV transplant programs free up the next available organ from a deceased donor not diagnosed with HIV, which then goes to the next patient waiting for a transplant.”
We firmly agree with her and other advocates that removal of the research requirement will only serve to increase the availability and access to organ transplantation for both PLWH and for individuals who are not living with HIV. Furthermore, we also concur with her that it is absolutely essential to ensure that information about the legality and real-time implementation of the HOPE Act (e.g., the number of successful HIV-to-HIV transplantation procedures) is made available for public consumption on the organdonor.gov website and via as many government-supported organ donation education outlets for patients and providers as possible. Accordingly, we strongly endorse the draft recommendation currently under consideration for voting by ACBTSA as a critical step toward achieving more equitable access to organ donation for PLWH.
Further communication regarding this public comment submission can be directed to Mr. Cheriko A. Boone (pronouns; honorific: he, him, his; Mr.), HIV Project Director of Treatment Action Group.
Cheriko A. Boone