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Safe use of plasma for life-saving treatment.
Plasma medicines used to treat people with auto-immune diseases and other conditions will soon be able to be produced using plasma from donors in Scotland - ensuring patients have improved access to treatment.
These medicines, called immunoglobulins, are produced from blood plasma donated by the public, and manufactured through a process called fractionation.
Since 1998 UK plasma has not been able to be used for fractionation in response to concerns over the spread of a human variant of BSE, known as ‘mad cow’s disease’, called variant Creutzfeldt Jakob Disease. Instead, the NHS has fully relied on imports of plasma-derived medicinal products from other countries.
Now, following a comprehensive review of risks associated with using UK plasma for fractionation by the Medicines and Healthcare products Regulatory Agency (MHRA), experts from the Commission on Human Medicines have advised that the use of UK-sourced plasma to manufacture these treatments is safe and can recommence as the risk is now considered to be negligible.
Public Health Minister Mairi Gougeon said:
“Global demand for plasma is increasing and I welcome the Commission on Human Medicines’ recommendations. This will allow these vital products to be produced using plasma from donors in the UK, therefore improving the availability of supplies which will continue to help improve the lives of patients who rely on them.
“Thank you to everyone in Scotland who has and continues to donate blood to help others. And now, as a result of our decision to lift the ban, plasma from selfless donors across the country will now be used for production of these life-saving treatments, providing a reassurance to those in need. The Scottish National Blood Transfusion Service will now work to review options for the collection and use of plasma.
“The ban on the pharmaceutical use of UK donors’ plasma was initiated as a precautionary measure. The rigorous risk assessment was undertaken last year by the MHRA, in consultation with patients, and follows calls from patient organisations in recent years to lift the ban on use of UK plasma to help ensure supplies.”