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Government removes ban on UK-sourced blood plasma for the manufacture of immunoglobulins

UK patients will soon have increased access to life-saving treatments made from locally sourced blood plasma, as the government lifts a decades-old ban on donations of plasma in the UK being used for the manufacture of immunoglobulins.

The ban was introduced in 1998 in response to concerns over the spread of Creutzfeldt Jakob Disease (human BSE).

Up until now, the UK has depended on imports of blood plasma from other countries – mainly the US – to manufacture immunoglobulins used to treat several serious diseases and conditions. Due to a large rise in global demand for immunoglobulins, both plasma and these treatments have experienced ongoing pressures on supply in the UK and around the world in recent years. The impact of the COVID-19 pandemic has also meant a significant drop in plasma donations from the US, further increasing pressures on supply.

The Medicines and Healthcare products Regulatory Agency (MHRA) undertook a comprehensive review of the evidence on the safety of UK blood plasma for the manufacture of immunoglobulins late last year, and the Commission on Human Medicines (CHM) have now advised that the use of UK-sourced plasma to manufacture these treatments is safe and can recommence, supported by a set of robust safety measures.

The lifting of the ban will bolster the UK's supply chain of immunoglobulins and improve self-sufficiency. The government will also introduce a new condition to ensure UK plasma is used first for UK patients and not exported to meet contracts elsewhere.

Convalescent plasma is currently being trialled in the UK for the treatment of COVID-19 and, if results are positive, immunoglobulins from plasma donated in the UK could in future be used to treat coronavirus patients.

Health Minister Lord Bethell said: "The safety of NHS patients remains our absolute priority and we have put in place robust precautionary measures to ensure every batch is safe."


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