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2012 Review

The aim of this review was to ensure that the deferral policies and the questions donors are asked are scientifically based, are relevant to Australia, and are in keeping with international practice. An expert Review Committee, chaired by Professor Steve Wesselingh met several times during 2011 and 2012 to consider eligibility policies for all sexual activity-based risks and recommend appropriate deferral policies.

Members of the public were able to make submissions to the Review Committee addressing concerns and providing suggestions regarding Blood Service deferral criteria relating to sexual activity. The Review Committee presented its findings to the Blood Service CEO in May 2012. The primary recommendation was that a 6 month deferral was acceptable conditional on supportive research.

Blood Services' response

After careful consideration of the Review Committee’s recommendations, the Blood Service initiated research to determine the response accuracy (rate of compliance) to the existing sexual activity-based screening questions. The study results were supportive that the level of non-compliance to the current screening questions in Australia is low.

(Lucky TT, Seed CR, Waller D, Lee JF, McDonald A, Wand H, et al. Understanding noncompliance with selective donor deferral criteria for high-risk behaviors in Australian blood donors. Transfusion. 2014 Jul;54(7):1739-49.)

Accordingly the Blood Service accepted the Review Committee’s key recommendation that the deferral period for all the sexual activity-based questions considered by the committee could safely be reduced from 12 months to 6 months.

Proposal to Therapeutics Goods Administration (TGA) and their response

A proposal setting out the supporting evidence for the change in deferral period and modifications to the screening questions was developed. In accordance with regulatory requirements, the Blood Service sought approval from the TGA to implement the changes.

Early in 2014 the TGA notified the Blood Service that they did not support the proposal resulting in no change to the current criteria. In making its decision, the TGA considered several key pieces of research, including:

  • The Blood Service commissioned expert review report handed down in 2012;
  • A donor compliance study by the Australian Red Cross Blood Service and Kirby Institute; and
  • The most recent annual data about infectious diseases in Australia, also from the Kirby Institute.

The TGA noted that reducing the deferral could increase the risk of an infection being passed on to a blood recipient with no significant boost to donor numbers, or to the blood supply.

Blood Service Chief Executive Jennifer Williams said at the time that the Blood Service accepted the TGA’s decision but was disappointed.

“In some countries, men are deferred either permanently or indefinitely, if they’ve ever had one sexual experience with another man. Australia’s 12-month deferral rule is less conservative than this, but the trend for shorter deferral periods is based principally on improved laboratory testing of the blood donations.

“The Blood Service will carry out a further review of this in approximately 5 years or earlier if there is a significant change to the factors that impinge on this subject,” Ms Williams said.

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