There are around 15.7 million blood donations collected in the US every year. The current risk of contracting HIV from a blood transfusion is around 1 in 2 million.
The ban was enforced in 1983 in the wake of the HIV/AIDS epidemic in the US, restricting all men who have had sex with other men since 1977 from donating blood due to their increased risk of HIV transmission.
In December 2014, the Food and Drug Administration (FDA) announced they have taken the decision to recommend the indefinite ban on blood donation for gay and bisexual men is removed, allowing these men to donate blood providing they have not had sex with another man in the past 12 months.
Yesterday, the FDA issued a draft guidance recommending this change, which - if implemented - will bring the US in line with blood donation regulations for gay and bisexual men in the UK, Australia, Sweden and Argentina, among many other countries.
Men who have ever tested positive for HIV and those who have ever engaged in commercial sex work or non-prescription injection drug use would remain indefinitely deferred from blood donation, however.
Individuals who have had sex with a person with a history of syphilis or gonorrhea or who have been treated for these conditions within the past 12 months would be unable to give blood, as would women who have had sexual contact with a man who had had sex with another man in the past 12 months.
Guidelines 'continue to stigmatize gay and bisexual men'
There is a major need for blood donations - in the US, a person needs a blood transfusion every 2 seconds. As such, the American Red Cross, the American Association of Blood Banks (AABB) and America's Blood Centers welcome the FDA's draft guidelines.
"The top priorities of the blood banking community are the safety of our volunteer blood donors and the ultimate recipients of blood," the organizations said in a joint statement. "This change in policy would align the donor deferral period for men who have sex with men with criteria for other activities that may pose a similar risk of transfusion-transmissible infections."
However, while gay rights activists have campaigned for a change in blood donation regulations for gay and bisexual men for many years, many believe these new guidelines are still not acceptable.
In a blog post from Human Rights Campaign (HRC) - the largest lesbian, gay, bisexual and transgender equal rights group in the US - HRC Government Affairs Director David Stacy says that while the new policy is a "step in the right direction," he believes it "falls far short" as it continues to stigmatize gay and bisexual men. He adds:
"This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply.
It simply cannot be justified in light of current scientific research and updated blood screening technology. We are committed to working towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve."
'Political and social concerns must not be allowed to trump public health'
According to the American Red Cross, there are around 15.7 million blood donations collected in the US every year, and the current risk of contracting HIV from a blood transfusion is around 1 in 2 million.
For the past 10 years, the American Red Cross, the AABB and America's Blood Centers have deemed the FDA ban on blood donations from men who have sex with men to be "medically and scientifically unwarranted."
However, some organizations are against the FDA's draft guidelines lifting the indefinite ban, stating that it should be kept in place because gay and bisexual men still present a significantly increased risk of HIV infection.
At the meeting of the FDA's Blood Products Advisory Committee in December last year, Peter Sprigg, senior fellow for policy studies at the Family Research Council, said:
"Research presented to the Committee confirmed the dramatically elevated risk of HIV infection among men who have sex with men - a risk 62 times higher than in the general public. This risk certainly justifies the highest level of vigilance, and political and social concerns must not be allowed to trump the public health."
New policy 'would not compromise blood safety'
In their draft guidelines, the FDA say there is evidence that the indefinite ban is becoming less effective over time for maintaining the current level of blood safety, and that the new policy would not compromise blood safety.
They point to the current policy in Australia - a country that has already adopted the regulation proposed by the FDA.
"During the 5 years before and 5 years after a change from a lifetime deferral to a 1-year deferral in Australia, there was no change in risk to the blood supply, defined by the number of HIV-positive donations per year and the proportion of HIV-positive donors with male-to-male sex as a risk factor," say the FDA.
They add that the compliance rate among gay and bisexual male blood donors following the policy change was at least 99.7%.
They note, however, that gay and bisexual male blood donors in Australia are required to sign a declaration in the presence of blood center staff stating that they understand there are penalties for providing false or misleading information - something that has not been proposed in the FDA's draft guidelines for the policy.
The FDA are inviting comments on the draft guidelines for 60 days, after which time they will make any amendments before finalizing them.
Medical News Today recently reported on a study claiming the use of fresh whole blood from single donors may lower the risk of transfusion-related illnesses for children undergoing heart surgery.