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A spokeswoman from the TGA confirmed it was prioritising the matter but could not provide a timeframe for its decision, considering it may seek further information from Lifeblood and external expert advice.
No other country has proposed such a change, but Australia has the largest plasma collection program per-capita in the world.
There are three kinds of blood donations: whole blood, plasma and platelets
Whole blood donation
This is the fastest and simplest form of donating blood. Once blood is drawn from your arm it is usually separated into red blood cells, plasma and platelets in the lab.
It takes 10 minutes to donate 470ml (about 8 per cent of the average adult’s blood volume). You can donate whole blood every 12 weeks.
Plasma donation
The process of donating plasma is called ‘apheresis’. It involves a special machine that uses centrifugal force to separate the blood drawn from your arm into plasma (which is yellow in colour) and your red cells. You can see this happening in the apheresis machine while you are donating, and your red cells are returned to your body during the same appointment.
Donating plasma rather than whole blood means twice as much plasma is collected (over half your blood is plasma), and you can donate more frequently (every two weeks).
It takes between 45 minutes and 1.5 hours to donate.
Platelets donation
Platelets are tiny fragments of cells made in bone marrow. They only last seven days after donation. Platelets clump together to stop bleeding, seal wounds and help plug leaks in damaged blood vessels.
It takes an hour to donate, and about two hours for the whole appointment. You must be male and have donated plasma before to donate platelets.
“You can imagine in a country where there is a very small plasma program this type of change would not be feasible, but we are in a very good position to be able to do this,” Pink said.
“We want to ensure that as many people as possible can safely donate,” Pink said. “I think it’s fantastic because it’s the most inclusive option and great for donor experience because we won’t need to ask questions about sexual activity.”
The population of Australian men who have sex with men is an estimated 300,000 people, and Kirby Institute data from June 2022 shows almost 37,000 people take PrEP.
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Matthew Mottola, 26, has not been eligible to donate blood since he was in high school and not yet sexually active.
“This is genuinely exciting news,” he said of Lifeblood’s TGA submission. “It’s very hard to reconcile the constant calls for donations while a large group of the population is being excluded from donating.
“Our queer community is so much more educated and aware of blood-borne diseases and our HIV status … [the current screening criteria] just feels very discriminatory.”
Should the TGA approve the changes, Lifeblood modelling suggests an additional 8000 to 9000 people would be added to Australia’s donor pool and start donating the blood product. Global demand for blood plasma is rising by 10 per cent every year.
Blood plasma products are used to treat more than 50 acute and chronic medical conditions including cancer, immune disorders, haemophilia, kidney disease and trauma patients.
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Australia’s stockpiles of blood plasma are primarily maintained by just 30,000 donors, and it can take up to 13 plasma donations to make a single dose of some plasma medicines.
In 2022, the TGA approved Lifeblood’s request to lift the ban on almost 750,000 people donating blood after living in the United Kingdom for six months or longer, put in place due to concerns about the impact of the country’s “mad cow” epidemic.
An approach adopted by some other countries is the “individual risk assessment” in which every potential donor would be asked the same questions about their sexual activity, including whether they have had anal sex with a new sexual partner, whether they have had multiple sexual partners and whether they are taking PrEP. If they answer ‘yes’, they cannot donate.
This approach is supported by advocacy group Just.Equal Australia.
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Lifeblood’s preliminary modelling suggests the individual risk assessment model would slightly increase the chance of being infected with HIV through blood transfusion from once in about 31 years to once in 18 years, and has committed to doing more research to determine whether individual risk assessment would be appropriate for other forms of blood donations.
If the TGA green lights the plasma pathway, there will be broader federal government approval process. Changes to the questionnaire would also need to be approved by state and territory governments, and CSL Behring – the pharmaceutical company that processes blood plasma – must also need to agree to accept the donations.
A spokesman for CSL said it would work with the TGA to assess the change and any potential impact on the products.
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