Report on Notifications Pursuant to §21 German Transfusion Act for 2008 and 2009.

SUMMARY

This report contains the data collected in 2008 and 2009, pursuant to Section 21 German Transfusion Act as well as an overview of the supply situation during the last 10 years. In 2009, blood donation services reported a total of 7.5 million donations - the largest amount since 2000. At the same time, more than 4.7 million red blood cell (RBC) concentrates and more than 500,000 platelet concentrates were available. The number of therapeutic single plasma units decreased to 1.1 million units in 2009. The loss rate for RBC concentrates is still between 3 and 4% for the users while for the manufacturers it has decreased slightly to 1.4%. The loss rate, for platelet concentrates, on the other hand, increased in 2009, especially-what is noteworthy-for manufacturers of pooled platelet concentrates. The loss rate for apheresis platelet concentrates accounted for 5.2% compared to 17.5% for pooled platelet concentrates. As far as the users were concerned, loss rates for platelet concentrates largely remained unchanged with rates between 5 and 6%. Based on the data collected, the supply with blood components for transfusion can be regarded as assured. Nearly 2.9 million 1 of plasma for fractionation were collected in Germany in 2009. According to reports from the pharmaceutical industry, out of these, 2.6 million 1 remained on the German market, out of which only 56% were fractionated in this country. Many plasma derivatives are not manufactured in Germany, despite the large amounts of plasma collected. The supply with these products, however, is assured by imports. Overall, 16,409 autologous and 9,435 allogeneic stem cell preparations were manufactured in 2009, out of which 3,382 allogeneic preparations were exported. 3,181 autologous and 2,374 allogeneic preparations were transplanted; 187 of these products from imports. The large number of exported stem cells and the small number of imported ones suggest that no serious shortages are to be expected for the supply with these products.