Plasma-derived medicines policies
Each plasma-derived medicine is unique, due to the pharmacological and manufacturing differences across different brands and to each patient’s unique response to the treatments. These therapies are non-interchangeable, sole-source biologics, therefore it is essential that patients have continued access to their specific therapy. One-size-fits-all policies are not suitable for plasma-derived medicines and endanger patient health.
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April 2, 2026
Perverse Consequences of Systemic Stockpiling of Plasma-Derived Medicinal Products in Europe
Plasma-derived medicinal products (PDMPs) are essential therapies made from donated human plasma. These medicines are often life-sustaining for patients with primary and secondary immunodeficiencies and are critical for maintaining functional integrity and quality of life in many rare and debilitating conditions, including dysimmune inflammatory neuropathies, rare bleeding disorders, alpha-1 antitrypsin deficiency, and other serious and rare diseases. Their supply chains differ fundamentally from those of chemically synthesised medicines and other biologics: they depend on a scarce biological starting material (donated human plasma), a long and highly regulated manufacturing (fractionation and purification) pathway, and a very limited ability to rapidly scale production . The fragility of the supply chain is further compounded by the EU’s structural dependence on plasmaimported from the United States, which accounts for approximately 38% of all plasma used for the manufacturing of PDMPs in Europe.
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April 2, 2026
Perverse Consequences of Systemic Stockpiling of Plasma-Derived Medicinal Products in Europe
Plasma-derived medicinal products (PDMPs) are essential therapies made from donated human plasma. These medicines are often life-sustaining for patients with primary and secondary immunodeficiencies and are critical for maintaining functional integrity and quality of life in many rare and debilitating conditions, including dysimmune inflammatory neuropathies, rare bleeding disorders, alpha-1 antitrypsin deficiency, and other serious and rare diseases. Their supply chains differ fundamentally from those of chemically synthesised medicines and other biologics: they depend on a scarce biological starting material (donated human plasma), a long and highly regulated manufacturing (fractionation and purification) pathway, and a very limited ability to rapidly scale production . The fragility of the supply chain is further compounded by the EU’s structural dependence on plasmaimported from the United States, which accounts for approximately 38% of all plasma used for the manufacturing of PDMPs in Europe.
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Plasma-derived medicines policies
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UK Department of Health
“Although the active ingredient in IVIg — purified immunoglobulin — is the same from brand to brand, there are considerable differences in the manufacturing processes used. This results in individual products that cannot be used interchangeably.”
Clinical Guidelines for Immunoglobulin Use; the UK Department of Health, 2008, p. 15
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UK Department of Health
“Although the active ingredient in IVIg — purified immunoglobulin — is the same from brand to brand, there are considerable differences in the manufacturing processes used. This results in individual products that cannot be used interchangeably.”
Clinical Guidelines for Immunoglobulin Use; the UK Department of Health, 2008, p. 15
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Iris – Association des patients déficit immunitaires primitifs, France
“Immunoglobulins are not interchangeable with each other, they are not generic medicines, prescribers must have long-lasting and readily available preparations.”
Immuno-déficience primitive, Recherche, Information, Soutien (I.R.I.S.) Position Statement Summary
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Iris – Association des patients déficit immunitaires primitifs, France
“Immunoglobulins are not interchangeable with each other, they are not generic medicines, prescribers must have long-lasting and readily available preparations.”
Immuno-déficience primitive, Recherche, Information, Soutien (I.R.I.S.) Position Statement Summary
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Plasma-derived medicines policies
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IPOPI – International Patient Organization for Primary Immunodeficiencies
“It is important to realize that there is no single immunoglobulin (Ig) product or method of administration that is suitable for all PID patients. [...] All countries and immunodeficiency centres should have access to a wide spectrum of Ig products, to provide optimal treatment for all immunodeficient patients.”
Frontiers in IMMUNOLOGY, Primary Immune Deficiencies – Principles of care; Hypothesis and Theory Article, published: 15 December 2014, doi: 10.3389/fimmu.2014.00627
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IPOPI – International Patient Organization for Primary Immunodeficiencies
“It is important to realize that there is no single immunoglobulin (Ig) product or method of administration that is suitable for all PID patients. [...] All countries and immunodeficiency centres should have access to a wide spectrum of Ig products, to provide optimal treatment for all immunodeficient patients.”
Frontiers in IMMUNOLOGY, Primary Immune Deficiencies – Principles of care; Hypothesis and Theory Article, published: 15 December 2014, doi: 10.3389/fimmu.2014.00627
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Plasma-derived medicines policies
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