TGA approves lowering of blood donation deferral period

The Australian Federation of AIDS Organisations (AFAO) has welcome the Therapeutic Goods Administrations’ (TGA) decision to revise the blood donation deferral period for men who have sex with men to three months.

Until now men who have had sex with men in the past 12 months cannot give blood due to risk of potential HIV transmission, which advocates claim to be discriminatory, scientifically inaccurate and counterproductive for the current health climate.

The TGA’s decision now needs to be approved by Commonwealth, state and territory governments and implemented by the Australian Red Cross Lifeblood (formerly knowns as the Blood Service).

The CEO of the AFAO, Darryl O’Donnell, said that it was essential to start aligning blood donation policy with relevant scientific evidence.

“This decision is an important improvement that better aligns Australia’s blood donation policy with scientific evidence,” he said

“The goal of our policy should be to ensure the safety of the blood supply while encouraging the largest possible pool of donors. The previous 12 month deferral period was excessive.

“This decision brings us in line with comparable nations such as Canada, and the United Kingdom. AFAO wishes to thank Lifeblood, the Therapeutic Goods Administration and other organisations that have supported this important reform.”

However, O’Donnell also noted that the deferral did not yet apply to people who use HIV prevention medicine, including pre-exposure prophylaxis (PrEP)

“The widespread use of PrEP outside clinical trials is relatively recent, and there hasn’t been enough real-world data at this stage to support a shorter deferral period for PrEP users,” he said

“We’re continuing to work closely with Lifeblood on this issue and will advocate for a lower deferral as soon as evidence allows. Our strong focus remains ensuring the highest standards of blood safety and ensuring no donor is needlessly excluded.”

The TGA’s decision comes after Lifeblood made a submission to the Australian regulator earlier this year asking to reduce the current sexual activity deferral period for gay and bi blood donors from 12 to three months.

The approved submission, which has been in development since 2017, assessed the most up-to-date clinical and scientific evidence.

This evidence included epidemiological data and improved testing technology, as well as the consistency of the practice in several other countries.

A Lifeblood spokesperson told Star Observer that they are pleased with the TGA’s decision to approve the submission, and noted that maintaining the safety of Australia’s blood supply was paramount.

“The TGA confirmed that their decision to approve our submission was made on the basis of the risk analysis we supplied which shows there would be no increased risk to the blood supply from the change,” they said.

“The safety and wellbeing of patients who receive blood products is foremost in all of our decision making, as well as the interest of donors. When it comes to blood safety for Australian patients, we need to ensure that we continue to maintain one of the safest blood supplies in the world.”

Thorne Harbour Health CEO, Simon Ruth, told Star Observer that these changes have been “a long time coming.” Ruth referred to the previous Victorian Minister for Health, Jill Hennessy, who tirelessly worked over four years to try to reduce the blood donation deferral period for sexually active gay and bisexual men.

Ruth, however, called into question the exclusion of PrEP users, noting the confusion behind excluding a group of people who are actively monitoring their sexual health.

“The exclusion of PrEP users prompts a lot of questions,” he said.

“What’s the rationale in excluding a cohort of the population that is looking after their sexual health through biomedical prevention of HIV and consistent quarterly testing for STIs? What does this mean for people that have used PEP in the last 12 months?”