The Government welcomes the Therapeutic Goods Administration’s approval of a ‘plasma pathway’, allowing a larger pool of donors to give plasma.
In a world-first, the plasma pathway is the initial step to remove questions regarding sexual activity from the plasma donor questionnaire. When implemented, this will enable donation from cohorts who have been excluded from blood and plasma donation based on their sexual activity, including men who have sex with men.
This approval comes after significant campaigning from the community, and a formal application from Lifeblood to the Therapeutic Goods Administration. The application was subject to the Therapeutic Goods Administration’s stringent, evidence-based assessment processes, with the pathway being assessed as clinically safe.
The existing deferral period remains in place for people who have had sexual activity with someone known to have a blood borne virus. Changes to deferral periods for blood donation were not included in this application to the Therapeutic Goods Administration.
An application from CSL Behring, as the manufacturer of blood and plasma products, will now be required for the plasma pathway to come into effect. States and Territories will then need to amend their respective questionnaires.
Quotes attributable to Assistant Minister for Health and Aged Care Ged Kearney MP
“This decision by the TGA is a welcomed step in enabling more people to donate plasma, including gay and bisexual men. It is an important decision in providing life-saving plasma to people who need it and one based on the best of medical evidence.”
“I pay tribute to those who have advocated for a more equal blood and plasma donation system as the TGA hands down this important decision.”
“I am hopeful CSL Behring will come forward with an application to the TGA so that we can see this decision translated into a fairer plasma donation system as soon as possible.”