- Australia has one of the safest blood systems in the world – and the safety of our blood and plasma products for patients will always be our top priority.
- Decisions about blood safety rules are made by the Therapeutic Goods Administration (TGA) and Australian governments following consideration of the information, data and evidence submitted by Lifeblood.
- We are pleased that our submission to remove sexual activity rules for plasma donation has been approved by the TGA.
- CSL Behring, which processes plasma into medications for patients, is supportive of the plasma pathway, and we are working with them and other stakeholders including the National Blood Authority and TGA to implement the change.
- The ‘plasma pathway’ that has been approved by the TGA, will:
- Allow anyone to donate plasma regardless of their sexual activity if they meet the other donor eligibility rules. This means someone with a new sexual partner could donate plasma without any wait period at all.
- Enable us to remove questions about sexual activity from the plasma donor questionnaire
- Enable someone on PrEP1 to donate plasma, while maintaining the safety of the blood supply.
- Australia will be the first country in the world to implement this plasma pathway.
Register so we can keep you up to date. Just click the link below, then fill out the form to be added to the notification list. You’ll then be the first to know of any potential changes.
If you’re already registered as a donor, you’ll still find out about any rule changes.
1 PrEP is an acronym that stands for pre-exposure prophylaxis. It involves HIV negative people taking antiretroviral medication to protect them and prevent HIV infection. Currently, people cannot donate whole blood for 12 months after they last took PrEP, or 3 months for plasma.
Keeping Australia's blood supply one of the safest in the world.
- The safety of our blood and plasma products is our top priority
- Australia currently has one of the lowest risks in the world of being infected with HIV through a blood transfusion, and we don’t want to change this.
- Unfortunately, even the very best blood screening tests cannot detect an early HIV infection – usually in the first week after infection. That’s why we need to do our best to make sure that people don’t donate blood if they might have an early ‘window period’ HIV infection.
- Australia has such a low HIV blood-transfusion risk because:
- The number of new HIV infections is reducing in the community
- We use the best blood screening tests
- Sexually active people in groups with a statistically higher risk of HIV infection cannot donate
- All countries have a period where people with higher-risk sexual behaviours may not donate - even though there are some differences in how those people are assessed.
- It is important for Lifeblood to propose a safe donation option that is available to as many people as possible. To be able to offer the ‘plasma pathway’ without impacting on patient safety would be a powerful and inclusive way to potentially allow more Australians to help others.
- Because safety of the blood supply is the highest priority, any change to blood safety rules takes time, research, and detailed analysis, and we need to know that any change is safe and feasible for patients as well as donors.
Plasma Pathway: a safe pathway towards more inclusive donation in Australia.
- Plasma is lifesaving
- The need for plasma – the lifesaving “golden” part of blood – is at a record high. Plasma has now overtaken whole blood donations as the type of donation most needed by Australian patients and hospitals.
- There are a growing number of patients relying on plasma donations for the treatment of cancer, immune disorders, haemophilia, trauma, and kidney disease. We need donations of all types. All donations save lives and plasma donations are equally as lifesaving as blood donations.
- Australia has one of the largest plasma collection programs (per head of population) in the world.
- Lifeblood collects more plasma donations than other blood donations each year.
- The manufacturing process for plasma donations contains several effective pathogen reduction steps to ensure the safety of plasma medicines, such as filters to remove viruses and other methods to inactivate or kill viruses.
- While our proposed 'plasma pathway' does not identify any increased HIV safety risk, the same steps used to process plasma donations are not available for other blood donations.
- Considering an individual risk assessment approach for blood donations
- Some countries have adopted an ‘individual risk assessment’ approach for sexual activity in blood donations. This approach varies, but generally involves asking donors if they have had multiple sexual partners in the last 3 months, or if they have had anal sex with a new sexual partner in the last 3 months. People who answer yes, cannot donate.
- Lifeblood has several concerns with this approach for Australia, including:
- Our preliminary modelling shows that allowing self-declared, monogamous gay men to donate would slightly increase the (very small) risk of being infected with HIV through a blood transfusion, increasing the risk from once in about 31 years to up to once in about 18 years.
- Individual risk assessment does not as fully cover the HIV window period risk, because the 3 months starts from first contact with a new partner, whereas our current approach starts from the last contact.
- If we used the same questions as other countries, the approach would allow people having sex with a partner from a high HIV-prevalence country to donate – and that is a higher risk group in Australia.
- There may be ways to make an individual risk assessment approach safe and appropriate for blood donation in Australia, but we need to do more research. We therefore plan to be more inclusive and if approved, implement the plasma pathway first.
- The table below compares the approaches:
2 MSM = men who have sex with men
Current approach Individual risk assessment Plasma pathway Questions about sexual activity as part of the donor questionnaire Yes Yes No Anal sex with one sexual partner for > 3 months MSM2 not eligible Eligible Eligible Anal sex with a new sexual partner for < 3 months MSM not eligible Not eligible Eligible More than one sexual partner in the last 3 months and anal sex with at least one of these partners MSM not eligible Not eligible Eligible PrEP within last 3-4 months Not eligible Not eligible Eligible
- Lifeblood’s next steps
- Following regulatory approval, we are now working with stakeholders including CSL Behring, to implement the plasma pathway as soon as possible.
- Lifeblood is currently undertaking a research program to enable us to decide whether to recommend an individual risk assessment approach for blood donation, and how that could be adapted to best suit Australia. We plan to make that decision within the next two years.
- The research program includes issues such as:
- Calculating the likely impact on the size of the donor panel – from newly eligible donors, and from losing currently eligible donors – and how to reduce those losses.
- Assessing the community’s attitudes towards the risk of a HIV transmission through a blood transfusion.
- Assessing the acceptability of asking all blood donors more detailed questions about their sexual activity.
Research Advisory Panel
Is Individual Risk Assessment possible for Australia? We're finding out.
Individual risk assessment is a way of assessing blood donors that’s being used in some other countries. Our panel of independent and Lifeblood experts advises on a research program helping Lifeblood decide if this kind of approach could work in Australia. The panel will review current research in the field, make recommendations on further research, interpret any research outcomes, and advise on how to structure and implement any recommended changes.
|Rodney Croome AM||LGBTIQA+ community advocate, board member of Just.Equal Australia, member of the Let Us Give campaign|
|A/Prof Joseph Doyle||Deputy Program Director, Burnet Institute; Infectious Diseases and Public Health Physician, Alfred Health and Monash University; President-elect, Australasian Society for Infectious Diseases|
|Dr Skye McGregor||Epidemiologist, Kirby Institute|
|Suzanne O’Callaghan||Research and Education Manager, Haemophilia Foundation Australia|
|Adj. Prof Darryl O’Donnell||CEO, Australian Federation of AIDS Organisations (AFAO), Adjunct Professor, Kirby Institute, UNSW|
|Mish Pony||CEO, Australian Sex Workers Association, Scarlet Alliance|
|Prof Iain Gosbell||Director Donor and Product Safety, Lifeblood Infectious Diseases Specialist|
|Dr Veronica Hoad||Public Health Physician, Lifeblood|
|Prof David Irving||Director Research and Development, Lifeblood|
|Peter McDonald||Executive Director Governance, Quality and Assurance, Lifeblood|
|Dr Joanne Pink||Chief Medical Officer / Executive Director Pathology and Clinical Governance, Lifeblood Haematologist|
|Cath Stone||Executive Director, Donor Engagement and Experience, Lifeblood|
|Jeremy Weiss||Director Marketing, Lifeblood|
Frequently asked questions
Check out our responses to frequently asked questions related to sexual activity.
- What are the current rules around sexual activity and blood donation?
The postponement for donating blood, plasma, and platelets for those with a sexual activity-based risk factor was reduced in 2021 from 12 months to three months since the last sexual contact.
If you answer ‘yes’ to any of the following questions, you’ll need to wait 3 months before you can donate.
In the last 3 months, have you:
• had oral or anal sex with another man, even ‘safer sex’ using a condom (if you’re a man)
• had sex (with or without a condom) with a male who you think may have had oral or anal sex (with or without a condom) with another man?
• been a male or female sex worker (i.e. received payment for sex in money, gifts or drugs?)
• had sex with a male or female sex worker?
• engaged in sexual activity with someone who ever injected drugs not prescribed by a doctor or dentist?
• engaged in sexual activity with someone who was found to have HIV, hepatitis B, hepatitis C or human T-lymphotropic virus (HTLV) infection?
In the last 12 months, have you had sexual activity with a new partner who currently lives or has previously lived overseas? If ‘yes’, you may need to wait to donate depending on the level of HIV risk in your partner’s country of residence.
- Can someone on PrEP currently donate blood?
If you’ve taken pre-exposure prophylaxis (PrEP) for HIV, see if you can plan ahead to donate.
Since October 2021, you’ll need to wait three months since your last dose before you can donate plasma. If you choose to donate blood, you’ll still need to wait 12 months since your last dose. This is because PrEP impacts the ability of testing to pick up early HIV infection.
The ‘plasma pathway’ that we are currently considering would, if determined to be safe and receives approval, enable donors who are taking PrEP to donate plasma.
- Why do you ask about my health history?
Our donation criteria, and questions on the donor questionnaire form, are designed to ensure that the blood collection process is as safe as possible for blood donors and patients alike.
Our pre-donation screening includes a questionnaire made up of three sections. The first looks at the health history of first-time donors and the second is a medical questionnaire for all donors. These two sections are designed to identify possible medical issues in potential donors, as well as general risks of infection.
The third section is a legal declaration for you to fill out, pertaining to specific infection risks such as sexual activity and blood exposures. Some of these questions ask about ‘sexual contact’ and ‘sex’. We use these terms to refer to any sexual activities including vaginal, oral or anal.
- I’m in an exclusive relationship, why can’t I donate blood?
We understand that there are different levels of risk among men who have sex with men. Right now, we are working on a solution that may allow all gay and bisexual men to donate plasma. We are also undertaking a research program to enable us to decide whether to recommend an individual risk assessment approach for blood donation, and how that could be adapted to best suit Australia.