Safeguarding plasma for fractionation: How can we deal with operational challenges in European Union countries.

The article discusses the global shortages of plasma for fractionation (PfF) and the increasing demand for immune globulins (IgG) products, particularly in high-income countries. In the European Union (EU), the volume of PfF collected does not meet the needs of patients for plasma-derived medicinal products (PDMPs). EU countries rely on plasma collected in plasmapheresis centers in the United States, which makes the EU strategically dependent on that country. This dependence on PfF import has negative consequences for global availability, especially in low- and medium-income countries. The article highlights the challenges and complexities in achieving self-sufficiency and strategic independence in PfF supply in the EU, including incomplete legislation, lack of national targets, and the absence of a direct feedback mechanism. The authors suggest strengthening the public sector and developing optimal tendering models for fractionation to increase PfF collection in the EU. [Extracted from the article]