11 / 2019
Extensive safety measures have ensured for a long time that blood components in Germany are very safe. Measures contributing to this include requirements for comprehensive testing for human immune deficiency virus, HIV, Hepatitis B (HBV), and Hepatitis C (HCV). The Paul-Ehrlich-Institut now also requires an additional test of blood components for Hepatitis-E virus (HEV). The test will be obligatory either as from 1 January 2020 or as from 1 January 2021, depending on the product.
The graduated plan procedure, which finally led to this new requirement, was initiated due to the increase in HEV infections reported to the Robert Koch-Institute. This increase in reports may, among other things provide evidence for the fact that the awareness for HEV infections has been raised. However, it could also mean that there is an increasing significance of HEV infections in blood donation. To ensure that HEV is not transmitted, the PEI has instated a requirement for HEV testing.
Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut explained: "As in all decisions involving measures in blood donations, the safety of patients receiving blood products is given top priority. For this reason, we now require general donor testing."
In concrete terms, the PEI requireslood components for transfusion, stem cell preparations from cord blood and for haematopoetic reconstitutions as well as therapeutic fresh plasma stored in quarantine to be tested for HEV using a suitable procedure.
This resolution will come into force in two stages. As per 01 January 2020: for red blood cell concentrates; platelet concen-trates; stem cell products from cord blood, and stem cells for haematopoetic reconstitution from peripheral blood or from bone marrow.
For therapeutic fresh plasma stored in quarantine, a longer transitional period is necessary. For a major part of the therapeutic fresh plasma manufactured in the meantime, it would not have been possible to implement the required tests by 01 January 2020 due to their long-term storage. For this reason, the requirement for these fresh plasma products will not come into force before 01 January 2021.
With the newly published notification, the PEI has also defined the requirements for the test systems implemented. This decision serves to complete step 2 of a graduated plan to combat risks of medicinal products pursuant to the German Medicines Act.
A preceding measure was an exchange of information in step 1 with the pharmaceutical companies on 23 February 2017, a written consultation of 04 June 2018 and a public hearing on 15 November 2018 within the framework of Step 2.
Contact:
Paul-Ehrlich-Institut
Press Office
Telefon: +49 6103 77 1030
Email: presse@pei.de
Updated: 20.05.2019
