Changes to blood and plasma donation in 2024

Changes to blood and plasma donation in 2024

by Adj. Prof. Stephen Cornelissen AM, Lifeblood CEO

There is no question blood donation rules for gay and bisexual men must change. We hear their pain and frustration when they can’t do something so many people take for granted – help their fellow human being with the simple yet life-giving act of donating blood or plasma.

Of course, the safety of blood and plasma products for patients will always be our number one priority, but Lifeblood wants change too, and we can do it in a way that safely goes even further than what is being done overseas. We want to propose donation options that allow as many people as possible to donate, including those with new or multiple partners and the tens of thousands taking PrEP, an antiretroviral medication to prevent HIV.

To this end, we have been working towards two approaches. One would allow everyone, regardless of their sexual activity, including gay and bisexual men, and anyone taking PrEP, to donate plasma without any wait period at all through the ‘plasma pathway’. The other sees people donating blood using what’s called an individual risk assessment (IRA) or a gender-neutral approach, where all donors are asked the same questions regardless of their gender.

Why two approaches and not just a gender-neutral approach as introduced in the United Kingdom, Canada, and United States? Because under this approach, many people who can’t donate under current rules in Australia would remain ineligible to donate blood and plasma. In the US, it is estimated that three quarters of the gay and bisexual population remain ineligible. We know we can do better in Australia by having a way forward that allows for both plasma and blood donations, and we can do it without impacting on patient safety. It doesn’t have to be an ‘either/or’ approach.

In May this year, our submission for the plasma pathway was approved by the Therapeutic Goods Administration. Importantly, the submission included those on PrEP, who must wait 3-12 months to donate under IRA.  Because plasma for plasma medicines undergoes a different type of processing called pathogen inactivation that reduces the risk of an infection being passed on to a patient, our submission focused on this vital blood product. We’re now working with stakeholders on a timeline to start these plasma collections in 2024.

At the same time, we set up a research advisory group to look at how individual risk assessments for blood donation could work in Australia. The work this group is doing will help shape a submission to the TGA in 2024 seeking approval to commence individual risk assessments for blood donation.

Being able to have these two approaches working side by side means Australia would be the first country in the world to remove wait times for plasma donation for gay and bisexual men taking PrEP or having anal sex with new or multiple sexual partners, and have individual risk assessments for blood donation, under which gay and bisexual men having sex with only one partner in the three months prior would become eligible to donate blood.

We acknowledge that gender-based sexual activity rules, whilst necessary to ensure a safe blood supply in the past, have contributed to the stigma faced by gay and bisexual men in Australia. This dual approach to blood and plasma donation offers the greatest opportunity for people to save lives – a common goal for both Lifeblood and advocacy groups – and is a world-first opportunity to change donation options for gay men without compromising the safety and quality of Australia’s blood supply.