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TGA approves reduction of the deferral period for whole blood donors with sexual activity risk factors
The Therapeutic Goods Administration (TGA) has evaluated an application submitted by Australian Red Cross Lifeblood (Lifeblood) which proposes to reduce the deferral period for donors of whole blood with a sexual activity-based risk factor from 12 to three months since the last sexual contact.
The proposed change to the donor deferral has been approved by the TGA, based on the evidence provided in the Lifeblood submission and advice received from the Advisory Committee on Biologicals.
The decision has been made on the basis of the risk analysis supplied by Lifeblood which demonstrates that recipient safety remains within accepted risk tolerance parameters.
Following the regulatory decision to accept the proposal to reduce the deferral period, implementation of the change will involve consideration by the Commonwealth, State and Territory governments that fund and indemnify Lifeblood's activities.
Consideration of the proposal
The application has been evaluated by specialist scientific and medical evaluators within the TGA. As part of this process, we also considered advice from the Advisory Committee on Biologicals to inform the final TGA decision.
In Australia, there is currently a 12-month deferral period for donors whose sexual practices put them at increased risk of acquiring infectious diseases that can be transmitted by blood, cells or tissues. This deferral period is applied to a number of donor groups with sexual activity-based risk factors, including sex work and male-to-male sex.
Over the past few years, a number of international regulators have moved to reduce deferral periods for donors with high risk sexual practices, based on accumulating scientific evidence. For example, in November 2017 the UK began incrementally moving from 12 to three months for deferrals for all sexual activity-based risks including male-to-male sex. Canada and the USA also reduced the blood donation waiting period for men who have sex with men from one year to three months on 3 June 2019 and 2 April 2020, respectively. The deferral period for high-risk sexual practices in NZ remains at 12 months.
Sexual activities covered by the reduced deferral period
The Lifeblood submission proposed a change to the donor deferral period from 12 months to three months for whole blood donors only reporting the following activities:
- for male donors: male-to-male sex
- for female donors: sex with a man who has ever had sex with a man
- for transgender donors: sexual contact with a male
- sex work
- sexual contact with a sex worker (male or female)
- overseas sexual contact with a resident of a HIV high prevalence country
- sexual contact with an injecting drug user (current or past)
- sexual contact with a partner known to be infected with a blood-borne virus (HIV, HBV, HCV or HTLV)
The changes are only for whole blood donations at this stage
Donors for plateletpheresis and plasmapheresis (plasma for fractionation) are outside the scope of the Lifeblood submission and will still be subject to the current 12-month donor deferral period. A separate submission would be required to change the deferral period for these groups of donors.
Donors currently receiving pre-exposure prophylaxis HIV prevention (PrEP) treatment are outside the scope of this submission, and the deferral period for those donors remains unchanged at 12 months post PrEP. A separate submission would be required to change the deferral period for that group of donors.
Donors with new partners from HIV risk areas are also outside the scope of this proposal and the deferral period for those donors remains at 12 months.
The scope of any change in donor deferrals resulting from this submission is restricted to Lifeblood and does not apply to other sponsors/products.