The Department of Health & Human Services has identified four areas of study to pursue before the regulatory ban on gay men donating blood can be lifted.
In a question-and-answer document requested by Sen. John Kerry (D-Mass.) and Rep. Mike Quigley (D-Ill.) made public Tuesday, the department outlined steps that the Blood, Organ, and Tissue Safety Working Group have identified as necessary before gay and bisexual man are allowed to donate blood.
Proposed studies are aimed to address the following four issues:
* how the risk of blood transmissible diseases in the current donor population relate to risk factors in donors;
* the root cause of Quarantine Release Errors, or the accidental release of blood not cleared for use;
* if potential donors correctly understand the current questionnaire and if men who have sex with men would comply with modified deferral criteria; and
* if alternative screening strategy, such as pre- and post-qualifying donation infectious disease testing, for men who have sex with men would assure blood safety while enabling collection of data that could demonstrate safe blood collection.
Under current regulation, men who have had sex with other men since 1977 — even once — aren’t eligible to donate blood.
Last year, the Advisory Committee on Blood Safety & Availability for HHS voted to recommend that the ban not be changed and cited insufficient scientific data to support revision to the policy. However, the committee also recommended additional research to support a policy allowing low-risk gay and bisexual men to donate blood.
The Q&A prepared by HHS asserts that the department is evaluating these four concerns. To determine the relationship between the risk of transmitting blood diseases with risk factors in donors, HHS has this year instituted a study of baseline data. To determine potential errors in release of blood not cleared for use, HHS plans to hold a public workshop with blood establishments and stakeholders later this year.
“The Department’s Blood, Organ, Tissue Senior Executive Council is currently assessing how the above mentioned studies can be supported with limited resources to include long term monitoring through a national hemovigilance program (monitoring or surveillance of the blood supply and blood recipients),” the document states.
Asked whether HHS officials foresee an end to the gay donor ban, HHS doesn’t explicitly say whether the ban will come to end, but that the department is willing to revisit the issue after more information is gathered.
“The Department has worked to develop a plan that will yield scientific data that are currently needed to re-evaluate the policy based on the ACBSA,” HHS states. “When these studies are complete, the Department is committed to a full evidence-based evaluation of the policy. If the data indicate that a change is possible while protecting the blood supply, we will consider a change to the policy.”
In statements, Kerry and Quigley applauded HHS for taking additional steps to lift the ban on gay blood donors.
Kerry said he’s been “working on this a long time in a serious way” and is glad HHS “responded with concrete steps to finally remove this policy from the books.”
“HHS is doing their due-diligence and we plan to stay focused on the end game — a safe blood supply and an end to this discriminatory ban,” Kerry said.
Quigley said the announcement from HHS means “we’re moving in the direction of finally ending this antiquated and discriminatory policy.”
“Sen. Kerry and I will continue to push for a behavior-based screening process both in the name of fairness and a safer blood supply,” Quigley said.
LGBT advocates also praised HHS for taking steps toward allowing gay and bisexual men to donate blood.
Nathan Schaefer, director of public policy at the New York-based Gay Men’s Health Clinic, said he’s “pleased to see” the U.S. government take “critical steps to review outdated blood donation policies.”
“As this research agenda is pursued, GMHC will continue educating the public about the negative consequences of current blood donation policies, and advocating for revised policies that would allow low-risk gay men to donate blood and maintain the highest standard of blood safety,” Schaefer said.