PPTA encourages EDQM to take a patient-centric approach in the implementation of its Plasma Supply Management Recommendations
The European Commission and the European Directorate for the Quality of Medicines (EDQM) recently published recommendations on plasma supply management in Europe. The recommendations were drafted by a working group of transfusion specialists representing national blood services (also called the TS093 working group). PPTA thanks the EDQM and the European Commission for addressing this important issue but is concerned that the recommendations do not go far enough towards ensuring the collection of sufficient plasma to meet the growing clinical need for plasma-derived medicinal products (PDMPs).
More patients across the European Union are diagnosed every year with life-threatening plasma protein related disorders, such as Hemophilia and other bleeding disorders, immune deficiencies, Hereditary Angioedema, and Alpha 1-Antitrypsin Deficiencies. In many cases, PDMPs are the only treatment option for these rare diseases. New indications, improved diagnostic techniques, greater use in emerging markets, and an increased use in cancer treatment-induced secondary immunodeficiency are further contributing to the growing clinical need for PDMPs.
National blood services collect only a marginal amount of plasma needed for PDMP manufacturing, and currently Europe is reliant on the U.S. for 35% of its plasma. Today, just four countries (Austria, Czechia, Germany, and Hungary) contribute more than half of the total plasma collected in Europe by allowing the coexistence of public and privately-owned collection centers and by compensating donors for their time and inconvenience related to the donation. This model is similar to the compensation model for the donation of tissues and cells (Directive 2004/23/EC, also referred to as the European Tissues and Cells Directive).
Maarten Van Baelen, Executive Director PPTA Europe, comments: “While national blood services contribute to the collection of plasma (mainly recovered from whole blood collection), they are unable to keep up with the growing need for plasma required to manufacture PDMPs.” He adds: “Our understanding is that the reluctance of some national stakeholders including national blood centers to endorse the coexistence of private enterprise and permit the compensation of plasma donors is largely based on concerns that this will lead to a reduction in whole blood donations. There is, however, no data available to substantiate this. On the contrary, experience in and studies from those countries where coexistence of public and privately-owned collection centers has been in place for many years, show that there have been no signs of a so-called ‘crowding out’ effect.”
PPTA asks that future European policies, at the Member State or EU level, should consider the differences between blood and plasma collection as well as differences between transfusable blood products and PDMPs. Any measure or new policies addressing plasma collection should be both patient- and donor-centered, based on strong science, and focused on meeting the growing clinical need. These policies should also promote coexistence by acknowledging the valuable contributions of both the public and private sectors to blood and plasma collection.
Director, Global Communications
- Created on .