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This is an archive article published on May 12, 2023

FDA relaxes blood donation rules for gay and bisexual men: What are the new changes and why they have been introduced

The move has come in line with FDA in recent years easing its blanket ban on gay and bisexual men from donating blood. The prohibition was first implemented during the HIV/AIDS crisis in the 1980s and has been long decried as discriminatory by the LGBTQI+ community and its supporters.

Blood DonationsA person donates blood to the American Red Cross during a blood drive in Pottsville, Pennsylvania. (Lindsey Shuey/Republican-Herald via AP)
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FDA relaxes blood donation rules for gay and bisexual men: What are the new changes and why they have been introduced
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The US Food and Drug Administration (FDA) on Thursday (May 12) said it has formally ended its longstanding restrictions barring gay and bisexual men from donating blood. The agency added it is finalising a recommendation that includes a questionnaire to screen donors based on their recent sexual activity rather than their sexual orientation or sex.

The move has come in line with the FDA in recent years easing its blanket ban on gay and bisexual men from donating blood. The prohibition was first implemented during the HIV/AIDS crisis in the 1980s and has been long decried as discriminatory by the LGBTQI+ community and its supporters.

“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

What has changed?

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As per the latest FDA guidelines, gay and bisexual men in a monogamous relationship with a man won’t have to refrain from sex before donating their blood. Previously, it was mandatory for them to have a three-month deferral period in which they refrained from having sex with another man.

Ever since the outbreak of the global epidemic of HIV/AIDS, the FDA had implemented a lifetime ban on blood donations from gay and bisexual men in the US, claiming the policy helped it to keep HIV out of the blood supply. It finally junked the prohibition in 2015 but said men who have sex with men (MSM) would have to abstain from sex for one year before giving blood. The time limit was further reduced to three months in 2020.

Although the new guidelines have done away with this deferral period for monogamous MSM, it stays in place for those who have had new or multiple partners, and anal sex, in the past three months.

“All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.,” said the FDA in a statement.

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Apart from this, according to the new guidelines, all potential donors — regardless of their sexual orientation, sex or gender — will now be screened with a new questionnaire that evaluates their individual risks for HIV based on sexual behaviour, recent partners and other factors.

Meanwhile, the agency hasn’t changed its policy around those who have tested positive for HIV as they will remain ineligible to donate blood. “Those taking pills to prevent HIV through sexual contact will also still be barred, until three months after their last dose. The FDA noted that the medications, known as PrEP, can delay the detection of the virus in screening tests.,” PBS reported.

The FDA has said that the new changes in its policy for blood donation are a recommendation to the industry. Blood banks aren’t mandated to follow them, so the rules may differ slightly from place to place, CNN said in a report.

How have people responded to the new guidelines?

The response from blood banks, medical groups and LGBTQI+ advocacy organisations has been mostly favourable.

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Sarah Kate Ellis, President and CEO of GLAAD, the Gay and Lesbian Alliance Against Defamation, in a statement, said the new recommendations signal “the beginning of the end of a dark and discriminatory past rooted in fear and homophobia”. However, like many, Ellis pointed out that the latest guidance didn’t go far enough as it still prohibits LGBTQI+ people who are on PrEP from donating blood, CNN reported.

“Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives. GLAAD urges the FDA to continue to prioritise science over stigma and treat all donors and all blood equally,” Ellis added.

Why have these changes been implemented?

The latest guidelines have been introduced to not just address the discriminatory nature of the existing policy, but also boost blood donations across the US. According to media reports, the number of blood donations in the country plummeted during and after the outbreak of the coronavirus pandemic as school and office-based blood drives decreased.

In January this year, when FDA first unveiled the changes in the policy, Marks had said, “Maintaining a safe and adequate supply of blood and blood products in the US is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”

Who is prohibited from donating blood in India?

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In March, the Centre told the Supreme Court that transgenders, gay people, and female sex workers aren’t allowed to donate blood based on scientific evidence. It said, “There is substantial evidence to show that transgender persons, men having sex with men and female sex workers are at risk for HIV, Hepatitis B or C infections.” The government also cited research from a slew of local and international “reputed scientific journals” such as the International Journal of Community Medicine and Public Health and the International Journal of STD & AIDS.

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