Men who have had sex with other men at any time since 1977, the beginning of the AIDS epidemic in the United States, are currently deferred as blood donors, under a policy of the U.S. Food and Drug Administration (FDA). MSM, as a group, are at higher risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.
The policy is not unique to the U.S. Many European countries have recently reexamined both the science and ethics of the lifetime MSM deferral, and have retained it.
A history of male-to-male sex is associated with an increased risk for the presence of and transmission of certain infectious diseases, including HIV, the virus that causes AIDS. The FDA's policy is intended to protect all people who receive blood transfusions from an increased risk of exposure to potentially infected blood and blood products.
The deferral for men who have had sex with men is based on the following considerations regarding risk of HIV:
FDA's deferral policy is based on the documented increased risk of certain transfusion transmissible infections, such as HIV, associated with male-to-male sex and is not based on any judgment concerning the donor's sexual orientation.
Male to male sex has been associated with an increased risk of HIV infection at least since 1977. Surveillance data from the Centers for Disease Control and Prevention (CDC) indicate that men who have sex with men and would be likely to donate have a HIV prevalence that is at present over 15 fold higher than the general population, and over 2,000 fold higher than current repeat blood donors (i.e., those who have been negatively screened and tested) in the U.S. MSM continue to account for the largest number of people newly infected with HIV.
Men who have sex with men also have an increased risk of having other infections that can be transmitted to others by blood transfusion.
Having had a low number of partners is known to decrease the risk of HIV infection. However, to date, no donor eligibility questions have been shown to reliably identify a subset of MSM (e.g., based on monogamy or safe sexual practices) who do not still have a substantially increased rate of HIV infection compared to the general population or currently accepted blood donors. In the future, improved questionnaires may be helpful to better select safe donors, but this cannot be assumed without evidence.
The FDA's policies on donor deferral for history of male sex with males date back to 1983, when the risk of AIDS from transfusion was first recognized. Our current policy has been in place since 1992.
The FDA has modified its blood donor policy as new scientific data and more accurate tests for HIV and hepatitis became available. Today, the risk of getting HIV from a blood transfusion has been reduced to about one per two million units of blood transfused. The risk of hepatitis C is about the same as for HIV, while the risk of hepatitis B is somewhat higher.
The FDA scientists continue to monitor the scientific literature and to consult with experts in CDC, National Institutes of Health (NIH) and other agencies. The FDA will continue to publicly revisit the current deferral policy as new information becomes available.
On March 8, 2006, the FDA conducted a workshop entitled "Behavior-based donor deferrals in the Nucleic Acid Test (NAT) era." The workshop addressed scientific challenges, opportunities, and risk based donor deferral policies relevant to the protection of the blood supply from transfusion transmissible diseases, seeking input on this topic. Participants were given the opportunity to provide scientific data that could support revising the FDA's MSM deferral. The workshop provided a very active, open and broad-based scientific dialogue concerning current behavior-based deferrals and explored other options that may be considered and the data needed to evaluate them.
The FDA's primary responsibility is to enhance blood safety and protect blood recipients. Therefore the FDA would change this policy only if supported by scientific data showing that a change in policy would not present a significant and preventable risk to blood recipients. Scientific evidence has not yet been provided to the FDA that shows that blood donated by MSM or a subgroup of these potential donors, is as safe as blood from currently accepted donors.
The FDA remains willing to consider new approaches to donor screening and testing, provided those approaches assure that blood recipients are not placed at an increased risk of HIV or other transfusion transmitted diseases.
Reviewed by health care specialists at UCSF Medical Center.
This information is for educational purposes only and is not intended to replace the advice of your doctor or health care provider. We encourage you to discuss with your doctor any questions or concerns you may have.