TGA approval to change blood donation rules relating to vCJD deferral

The Therapeutic Goods Administration (TGA) has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'.

This decision follows an application made to the TGA from the Australian Red Cross Lifeblood to remove the deferral which is applicable to blood and plasma donors having spent a cumulative length of time of 6 months or more in the UK between 1980 and 1996.

The TGA conducted a scientific, epidemiological and clinical assessment of the risk model submitted by Lifeblood. The TGA concluded that the modelled risk is reliable and by removing the deferral of vCJD the risk of transfusion transmission of vCJD would remain very low.

The change will result in a potential modest increase in the number of blood and plasma donors in Australia.

The section 14 consent letter confirming this decision has been published today.

For further information you can contact us at infectiousdiseasesafety@health.gov.au.

Australian blood donors can find further information on the Lifeblood website.