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Primary Immune Deficiency

4 NATIONS AGREEMENT ON LIFTING THE UK PLASMA BAN

UKPIPS TRUSTEE STATEMENT – ANNOUNCING THE 4 NATIONS AGREEMENT ON LIFTING THE UK PLASMA BAN

 

UKPIPS is absolutely delighted to announce that the ban on UK plasma being used for the manufacture of immunoglobulins has finally been lifted, after concerted campaigning over the two years.

By lifting the ban (which has been in place since 1998), plasma donations from UK blood donors can be used to manufacture immunoglobulins for NHS patients.

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.  Experts at the independent Commission on Human Medicines (CHM) then made the decision that it would be safe to lift the ban in the UK, requesting that all collectors and manufacturers abide by a number of robust safety standards and risk mitigation measures, including the ability to trace donations from donor to patient.  Every medicine will be individually reviewed and evaluated by teams at the MHRA.

Up until now, the UK has been dependent on imports of blood plasma from other countries (mainly the US) for the manufacture of our IgG  products.

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 COVID-19 pandemic has also meant a significant drop in plasma donations from the US, further increasing the pressure on supply.

Lifting the ban will bolster the supply chain and improve the self-sufficiency of the UK in producing its own treatments.  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.

UKPIPS has been campaigning with other organisations for a long time to achieve this and for us, as patients, it is great news. Thanks must go to UKPA (United Kingdom Plasma Action) for their unrelenting campaigning on this front.

Full details here

Published 27th February 2021

Amended 18th February 2022 (Old News)

UKPIPS is grateful for the support of Takeda