The UK government is lifting its 20-year ban on the use of locally-sourced blood plasma, after a safety review gave the all-clear to risk of CJD transmission. The move will allow thousands of patients to benefit from medicines manufactured in the UK from donated blood plasma rather than rely on imported product.
The use of plasma in manufacturing immunoglobulins was banned in the UK in 1998, in response to concerns over variant Creutzfeldt-Jakob Disease (vCJD) and human bovine spongiform encephalopathy (BSE), commonly known as “mad cow disease.” A review by the Medicines and Healthcare products Regulatory Agency (MHRA) has determined it is safe to use plasma, with certain safeguards in place, including the ability to trace donations from donor to patient.
NHS Blood and Transplant currently collects about 350,000 litres of plasma each year as part of whole blood donation. Of that total, 100,000 litres are used for transfusion, while the other 250,000 litres are discarded.
Instead, the UK has relied on imports of blood plasma from other countries, the US in particular, to meet its needs for manufacturing plasma-based treatments. According to the Department of Health and Social Care, a large rise in the global demand for immunoglobulins in recent years has increased pressure on that supply, and the COVID-19 pandemic led to a further drop in plasma donations from abroad.
“The lifting of the ban will bolster the supply chain and improve the self-sufficiency of the UK in producing its own treatments,” according to the DHSC. Health Minister Lord Bethell added, “The safety of NHS patients remains our absolute priority and we have put in place robust precautionary measures to ensure every batch is safe.”
Australia imports some supplies of blood products such as IVIg, but the TGA requires that blood products from overseas manufacturers must comply with the Australian donor criteria. These state that donations cannot be accepted from anyone who lived in the UK between 1980 and 1997.
In 2004 a parliamentary inquiry into the ‘tainted blood’ scandal heard that thousands of Australian had potentially been infected with blood borne viruses such as hepatitis C from imported blood products.