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Parliamentary questions
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9 October 2020
Question for written answer E-005543/2020
to the Commission
Rule 138
César Luena (S&D)
 Subject: Plasma-derived medicines and the shortage of plasma donations in Europe

Plasma-derived medicinal products (PDMPs) are produced from human biological material and have a high complexity and a regulated manufacturing process. They are used to treat rare, chronic, severe diseases, often of genetic origin, primary and secondary immunodeficiencies, bleeding disorders, certain neurological diseases and other rare diseases associated with the absence or malfunctioning of specific proteins.

In Europe, plasma availability is extremely uneven. Just four countries donate more than 55% of the total plasma collected in Europe for the purposes of manufacturing.

Furthermore, there is a growing clinical need for PDMPs for European patients, as an increasing number of patients are diagnosed with diseases that require treatment with these products. However, the volume of plasma collected in the EU meets only 63% of Europe’s clinical needs. In addition to shortages, patients face other challenges, such as non-reimbursement and the high cost of treatment.

1. Is the Commission aware of this problem?

2. Does the Commission plan to take action to address the plasma shortage in Europe and to support Member States in obtaining sufficient doses?

3. Does the Commission plan to take action to improve patients’ access to this kind of treatment?

Original language of question: ES
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