Process

The review was completed in a number of stages:

Stage 1 – Establishing the review committee

  • The review was conducted by an expert group led by a chair. The chair was appointed by Lifeblood, and Lifeblood and the chair agreed on and invited the committee members.

Stage 2 – Review and recommendations on deferral duration

  • The committee reviewed all relevant medical and scientific literature subsequent to the 2012 review.
  • The committee developed a position paper incorporating the committee’s recommendations on the appropriate length of deferral for sexual activity-based risk.
  • The position paper and recommendations were forwarded to Lifeblood Chief Executive Officer for internal review.

Stage 3 – Review and recommendations on plasma donation by low risk currently ineligible donors

  • The Review Committee considered whether plasma for fractionation (which is subject to targeted pathogen inactivation during processing) provided an opportunity to expand donation by ‘lower risk’ sexual activity-based, currently ineligible donors (e.g. MSM in stable relationships), without negatively impacting recipient safety.
  • A position paper incorporating the committee’s recommendations on this potential strategy was drafted.
  • The position paper and recommendations were forwarded to Lifeblood Chief Executive Officer for internal review.

Stage 4 – Consideration and proposal(s) for regulatory approval

Lifeblood considered the recommendations in the position papers, consulted with stakeholders and made a submission to the Therapeutic Goods Administration (TGA) in support of changes to current practice.

Stage 5 – Implementation

Following approval from the TGA, approval was sought from all governments prior to implementation of the changes.

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