The revision of the EU Blood Directive
The European Commission is currently revising the EU Blood, Tissue and Cells legislation, to take into account the most recent technological, scientific, epidemiological and societal developments.
Significant advancements have been made to increase the quality and safety of plasma-derived medicinal products (PDMPs), and the PDMP manufacturing process effectively removes and/or inactivates pathogens, which may be present in plasma for fractionation/manufacturing. As a result, there have been no virus transmissions via PDMPs in the past more than 25 years.
Blood products for direct transfusion and plasma for fractionation are consequently very different from a pathogen safety perspective.
The revision of the Blood Directive should thus adequately reflect progress in science and technology on regulatory requirements, and set deferral criteria, based on science and tailored to the safety profile of blood and plasma. This will ultimately lead to an increased plasma collection in Europe, for the benefit of 300,000 European patients who rely on PDMP therapies to treat a variety of rare, chronic, and potentially life-threatening conditions, such as immunodeficiencies, immune-mediated peripheral neuropathies, Hereditary Angioedema, Alpha 1-Antitrypsin Deficiencies, Haemophilia and other bleeding disorders for which PDMPs are often the only treatment option. New indications, improved diagnostic techniques, greater use in emerging markets, increased use in cancer treatment, contribute to growing clinical need for PDMPs.
This call to action is the outcome of the event “The revision of the EU Blood Directive: how to enhance plasma collection by getting more donors via increased regulatory efficiency?” hosted by MEP Sirpa Pietikäinen, which took place on 21 April 2021.
In order to increase plasma collection in Europe for the manufacturing of PDMPs and ensure the availability of PDMPs for patients, the revised EU Blood legislation should remove these barriers for plasma donors that are no longer supported by science and increase regulatory efficiency, by:
- Introducing a clear differentiation between whole blood and blood components for transfusion, and plasma for manufacturing of PDMPs;
- Including clear definitions of “plasma for manufacturing/for fractionation”, “plasma for transfusion”, “recovered plasma”;
- Revising existing eligibility criteria for plasma donors based on the newest technological and scientific progress. Donor eligibility criteria should take into account the ability of the PDMP manufacturing process to remove known and emerging pathogens, thus ensuring the highest quality and safety of the final product.
This call for action has already been endorsed by:
Members of the European Parliament