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Process

The review will be in a number of stages:

Stage 1 – Establishing the review committee

  • The review will be conducted by an expert group led by a chair. The chair has been appointed by the Blood Service, and the Blood Service and the chair have agreed on and invited the committee members.

Stage 2 – Review and recommendations on deferral duration

  • The committee will review all relevant medical and scientific literature subsequent to the review.
  • The committee will develop a position paper incorporating the committee’s recommendations on the appropriate length of deferral for sexual activity-based risk.
  • The position paper and recommendations will be forwarded to the Blood Service Chief Executive Officer for internal review.

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

  • The Review Committee will consider whether plasma for fractionation (which is subject to targeted pathogen inactivation during processing) provides 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 will be drafted.
  • The position paper and recommendations will be forwarded to the Blood Service Chief Executive Officer for internal review.

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

The Blood Service will consider the recommendations in the position papers, consult with stakeholders and determine if it is appropriate to progress submission(s) to the Therapeutic Goods Administration (TGA) in support of changes to current practice.

Stage 5 – Implementation

Subject to policy approval from the TGA, the Blood Service will consider the timeline for implementation.

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