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Application to reduce the deferral period for some blood donors under consideration
The TGA is evaluating an application submitted by Australian Red Cross Lifeblood, which proposes to reduce the deferral period for donors with a sexual activity-based risk factor from 12 to three months since the last sexual contact. This application follows a review initiated by Australian Red Cross Lifeblood in 2017.
The application is being evaluated by specialist scientific and medical evaluators within the TGA. As part of this process, we may consider any advice and recommendations from the Advisory Committee on Biologicals to inform the final TGA decision.
The TGA sets standards for blood donation in Australia to reduce the risk of transmitting infectious disease through the use of blood and blood components, in order to maintain the safety and integrity of the Australian blood supply. One of the strategies used to minimise the risk of transmitting infectious disease via blood and blood components is donor selection and testing.
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 was introduced in 2000 and is applied to a number of donor groups with sexual activity-based risk factors, including sex work and male-to-male sex.
A number of international regulators have over the past few years 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 also reduced the blood donation waiting period for men who have sex with men from one year to three months on 3 June 2019. The deferral period for high-risk sexual practices in the USA and NZ is 12 months.
On completion of the evaluation, we will decide what, if any, regulatory changes should be made regarding deferral periods for donors whose sexual practices put them at increased risk of infection that may be transmitted by transfusion. Our assessment and decision on the proposal is expected by the end of the first quarter 2020.
If our regulatory decision is to accept the proposal to reduce the deferral period, implementation of any change will involve consideration by other parties such as Commonwealth, State and Territory governments that make policy decisions and fund and indemnify Lifeblood's activities, as well as suppliers who process donated blood into other blood products.