J. Hesse

Bericht zur Meldung nach § 21 TFG für die Jahre 2008 und 2009

This report contains the data collected in 2008 and 2009, pursuant to Section 21 of the German Transfusion Act (Transfusionsgesetz), 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 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 red blood cell 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, and--what is noteworthy--especially 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 of blood components for transfusion can be regarded as assured. Nearly 2.9 million liters of plasma for fractionation were collected in Germany in 2009. According to reports from the pharmaceutical industry, of these, 2.6 million liters remained on the German market, of which only 56% were fractionated in this country; no statement can be made on the use of the remaining amount. Many plasma derivatives are not manufactured in Germany, despite the large amount of plasma collected. The supply with these products, however, is assured by imports. Overall, 16,409 autologous and 9,435 allogeneic hematopoietic stem cell preparations were manufactured in 2009, of which 3,382 allogeneic preparations were exported. A total of 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 stem cells suggest that no serious shortages are to be expected for the supply with these products.

Report on Notifications pursuant to Section 21 German Transfusion Act for 2001 and 2002

ZusammenfassungDem Bericht nach § 21 Transfusionsgesetz liegen Daten zugrunde, die sich für die Jahre 2001 und 2002 auf 4,53 und 4,66 Millionen allogene Vollblut- sowie auf 1,35 und 1,89 Millionen Apheresespenden beziehen. Die Menge des Plasmas zur Fraktionierung aus Apherese hat sich seit 2000 verdoppelt auf ca. eine Million Liter im Jahr 2002. Gleichzeitig ist auch die Zahl der privaten Aphereseeinrichtungen angewachsen. Die Zahlen für Plasma zur Fraktionierung insgesamt (aus Vollblut und aus Apherese) zeigen hauptsächlich aufgrund der Erhöhung der Plasmamengen aus Apherese für beide Berichtsjahre eine stark steigende Tendenz. Trotzdem verringerte sich im Berichtszeitraum wegen der ebenfalls steigenden Exportzahlen die auf dem deutschen Markt zur Verfügung stehende Menge an Plasma zur Fraktionierung um 43%. Die Daten zur Herstellung von Blutkomponenten sind verlässlich, da die Meldungen nahezu vollständig sind. Im Jahr 2001 wurden an Erythrozytenkonzentraten, dem wichtigsten Arzneimittel aus der Vollblutspende, 4,32 Millionen, im Folgejahr 4,45 Millionen hergestellt, davon knapp 77% in den Blutspendediensten des Roten Kreuzes. Die gemeldeten Verbrauchswerte lagen mit 3,2 Millionen Transfusionseinheiten im Jahr 2001 und 3,5 Millionen im Jahr 2002 deutlich unter den Herstellungszahlen. Allerdings ist ein Teil der Einrichtungen der Krankenversorgung der Meldeverpflichtung nicht nachgekommen. Bei den Daten zu Herstellung, Import und Export von Plasmaderivaten sind wegen der Komplexität der Materie und der zahlreichen zu berücksichtigenden Verflechtungen noch weitere Verbesserungen erforderlich. Eine Bilanz zur Versorgungslage ist jedoch aufgrund des Defizits an Verbrauchsmeldungen ohnehin noch nicht möglich.AbstractThe report pursuant to Section 21 German Transfusion Act is based on data referring to 4.53 and 4.66 million allogeneous whole blood donations and 1.35 and 1.89 million apheresis donations respectively for the years 2001 and 2002. Since 2000, the quantity of plasma for fractionation from apheresis has doubled to approx. 1 million litres in 2002. At the same time, the number of private apheresis facilities has also increased. The data on plasma for fractionation (both from whole blood and from apheresis) have shown a sharp increase for both report periods, mainly due to the rise in the quantity of plasma from apheresis. In spite of this, the quantity for plasma for fractionation available to the German market declined by 43% during the report period, due to increasing export figures. The data on the manufacture of blood components are reliable, since the notifications are almost complete. In 2001, 4.32 million transfusion units of erythrocyte concentrates, the most important product derived from whole blood donations, were manufactured, compared with 4.45 million in 2002, out of these, slightly less than 77 percent were manufactured in the blood donations services of the Re Cross. The consumption values reported were clearly below the figures for the manufacture, with 3.2 million transfusion units in 2001 and 3.5 million in 2002. However, some facilities of the health service did not meet the requirement to notify their figures. As far as the data on manufacture, imports and exports of plasma derivatives are concerned, further improvements are required because of the complexity of the matter and the various implications to be taken into account. However, a statement on the supply situation cannot be yet made anyway, due to the missing notifications on the consumption figures.

Bericht zur Meldung nach § 21 TFG für das Jahr 2007

The present report contains the data collected in 2007, pursuant to Section 21 German Transfusion Act, and an analysis of the supply situation over the past 8 years. As in previous years, all blood donation centres located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion. According to these data, a total of 6.7 million blood collections were performed in 2007. With 4.7 million, the portion of whole blood donations was at the level of previous years, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decay of red blood cell concentrates on the user side in 2000 accounted for 5% while in 2007 it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas, too, markedly increased in 2007 (to 1.2 million transfusion units). In 2007, 2.2 million I of plasma for fractionation were collected in Germany. In addition, 1.0 million I were imported, and 1.8 million I were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million I was almost entirely allocated to basic fractionation so that a sufficient plasma supply can be assumed. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 I of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for haematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700. A large portion of this (1,810 transplants) could be exported while only a small number (179 preparations) had to be imported. The manufacture of autologous stem cell preparations from cord blood has risen drastically to more than 10,000 in 2007. The interest in the figures collected in compliance with Section 21, German Transfusion Act remains high both in Germany and at an international level. Meanwhile reliable data are available.The present report contains the data collected in 2007, pursuant to Section 21 Transfusionsgesetz (German Transfusion Act), and an analysis of the supply situation over the past eight years. The recording of the data by online reporting is in the meantime well established and generally accepted. As in previous years, all blood donation centers located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion, so that meaningful data are available. According to these data, a total of 6.7 million blood collections were performed in 2007. The number of whole blood donations was at the level of previous years, with 4.7 million, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decrease in the portion of decay of red blood cell concentrates on the user side is particularly good news. In 2000, it accounted for 5% and in 2007, it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas also markedly increased in 2007 compared with previous years, accounting for 1.2 million transfusion units. In 2007, 2.2 million liters of plasma for fractionation were collected in Germany. This trend went hand in hand with the increasing number of apheresis donations that year. In addition, 1.0 million liters were imported, and, at the same time, 1.8 million liters were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million liters was almost entirely allocated to basic fractionation, so that a sufficient plasma supply can be assumed. The assessment of the degree of self-sufficiency is made difficult because of the influence of imports and exports; however, the results show no deficit for plasma derivatives. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 liters of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for hematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700 in the reporting year. A large portion of this, 1,810 transplants could be exported while only a small number, 179 preparations, had to be imported. The manufacture of autologous stem cell preparations from cord blood also rose drastically compared with 2006, to more than 10,000 in 2007. It must be emphasized that these products were entirely placed into stock; none were transplanted in the reporting year. The interest in the figures collected in compliance with Section 21, Transfusion Act remains high both in Germany and at the international level. Reliable data are available thanks to the evaluations of trends over years, above all on the availability of blood components for transfusion. In addition, the Paul Ehrlich Institute will continue to strive to meet the demands for high-quality information on the supply situation in the future.

Report on notifications pursuant to Section 21 German Transfusion Act for 2007

The present report contains the data collected in 2007, pursuant to Section 21 German Transfusion Act, and an analysis of the supply situation over the past 8 years. As in previous years, all blood donation centres located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion. According to these data, a total of 6.7 million blood collections were performed in 2007. With 4.7 million, the portion of whole blood donations was at the level of previous years, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decay of red blood cell concentrates on the user side in 2000 accounted for 5% while in 2007 it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas, too, markedly increased in 2007 (to 1.2 million transfusion units). In 2007, 2.2 million I of plasma for fractionation were collected in Germany. In addition, 1.0 million I were imported, and 1.8 million I were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million I was almost entirely allocated to basic fractionation so that a sufficient plasma supply can be assumed. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 I of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for haematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700. A large portion of this (1,810 transplants) could be exported while only a small number (179 preparations) had to be imported. The manufacture of autologous stem cell preparations from cord blood has risen drastically to more than 10,000 in 2007. The interest in the figures collected in compliance with Section 21, German Transfusion Act remains high both in Germany and at an international level. Meanwhile reliable data are available.The present report contains the data collected in 2007, pursuant to Section 21 Transfusionsgesetz (German Transfusion Act), and an analysis of the supply situation over the past eight years. The recording of the data by online reporting is in the meantime well established and generally accepted. As in previous years, all blood donation centers located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion, so that meaningful data are available. According to these data, a total of 6.7 million blood collections were performed in 2007. The number of whole blood donations was at the level of previous years, with 4.7 million, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decrease in the portion of decay of red blood cell concentrates on the user side is particularly good news. In 2000, it accounted for 5% and in 2007, it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas also markedly increased in 2007 compared with previous years, accounting for 1.2 million transfusion units. In 2007, 2.2 million liters of plasma for fractionation were collected in Germany. This trend went hand in hand with the increasing number of apheresis donations that year. In addition, 1.0 million liters were imported, and, at the same time, 1.8 million liters were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million liters was almost entirely allocated to basic fractionation, so that a sufficient plasma supply can be assumed. The assessment of the degree of self-sufficiency is made difficult because of the influence of imports and exports; however, the results show no deficit for plasma derivatives. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 liters of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for hematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700 in the reporting year. A large portion of this, 1,810 transplants could be exported while only a small number, 179 preparations, had to be imported. The manufacture of autologous stem cell preparations from cord blood also rose drastically compared with 2006, to more than 10,000 in 2007. It must be emphasized that these products were entirely placed into stock; none were transplanted in the reporting year. The interest in the figures collected in compliance with Section 21, Transfusion Act remains high both in Germany and at the international level. Reliable data are available thanks to the evaluations of trends over years, above all on the availability of blood components for transfusion. In addition, the Paul Ehrlich Institute will continue to strive to meet the demands for high-quality information on the supply situation in the future.

Report on notifications pursuant to Section 21 of the German Transfusion Act for the years 2008 and 2009

This report contains the data collected in 2008 and 2009, pursuant to Section 21 of the German Transfusion Act (Transfusionsgesetz), 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 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 red blood cell 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, and--what is noteworthy--especially 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 of blood components for transfusion can be regarded as assured. Nearly 2.9 million liters of plasma for fractionation were collected in Germany in 2009. According to reports from the pharmaceutical industry, of these, 2.6 million liters remained on the German market, of which only 56% were fractionated in this country; no statement can be made on the use of the remaining amount. Many plasma derivatives are not manufactured in Germany, despite the large amount of plasma collected. The supply with these products, however, is assured by imports. Overall, 16,409 autologous and 9,435 allogeneic hematopoietic stem cell preparations were manufactured in 2009, of which 3,382 allogeneic preparations were exported. A total of 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 stem cells suggest that no serious shortages are to be expected for the supply with these products.

Report on notifications with respect to section sign 21 German Transfusion Act for 2003 and 2004

ZusammenfassungDie nach § 21 TFG erhobenen Zahlen zu Herstellung, Gewinnung, Import und Export zeigen eine Konsolidierung, allerdings bleibt eine nicht plausible Diskrepanz zu den wesentlich niedrigeren Zahlen zur Anwendung der Arzneimittel. Da zahlreiche Verbrauchsmeldungen ausbleiben, ist eine Interpretation als Überversorgung nicht zulässig. Fremdblutspenden zeigten 2003 einen Spitzenwert (6,8 Millionen), davon 2,4 Millionen Apheresespenden, die 2004 auf 1,6 Millionen zurückgingen. Die Herstellungszahlen von Erythrozytenkonzentraten erreichten 2004 den Spitzenwert von 4,52 Millionen, mit 74% Anteil des Roten Kreuzes. Der gemeldete Verbrauch weicht so stark ab, dass das Paul-Ehrlich- Institut (PEI) die gesetzliche Möglichkeit erwägt, zukünftig Abgabelisten der Hersteller mit den Angaben der Einrichtungen der Krankenversorgung abzugleichen. Mit 2,4 Millionen Liter Plasma zur Fraktionierung wurde 2003 der bisher höchste Wert erreicht, mit einem Aphereseanteil von 62%, der 2004 auf 50% von insgesamt 1,9 Millionen Liter bei einer deutlichen Reduzierung kommerzieller Plasmapheresezentren sank. Die neue Abfrage (2004) zur Basisfraktionierung in Deutschland ergab 734.224 Liter Plasma, entsprechend 45% der rechnerisch am deutschen Markt verfügbaren Gesamtmenge. Bei den Plasmaproteinpräparaten ist eine isolierte Betrachtung der deutschen Situation angesichts komplexer Handelsströme und Arzneimittelherstellungsschritten in verschiedenen Ländern nicht möglich. Die Beurteilung der Versorgungslage ist durch unvollständige Verbrauchsmeldungen weiter erschwert. Bei der Hämophiliebehandlung wird eine Verbesserung durch die Etablierung eines Deutschen Hämophilieregisters angestrebt.AbstractData with respect to the § 21 Transfusion Act concerning collection, manufacture, imports and exports show consolidation, but a non-plausible discrepancy due to the considerably lower figures of product consumption. Failure of numerous institutions to report their consumption precludes an interpretation as surplus supply. Homologous blood donations peaked in 2003 (6.8 million) with 2.4 million thereof being apheresis, which decreased to 1.6 million in 2004. Manufacture of red cells reached a peak of 4.52 million in 2004, with 74% attributable to the Red Cross. Reported consumption differs so significantly that the PEI considers utilising the legal possibility to compare the distribution lists of blood services with submitted user data. The 2.4 million litres plasma for fractionation in 2003 constitute the hitherto highest value, with a 62% share of apheresis; the latter decreased in 2004 to 50% of 1.9 million litres, paralleled by a decrease in commercial plasma centres. The new request (2004) for figures of fractionation in Germany revealed 734,224 litres, i.e. 45% of the calculated available amount on the German market. Isolated consideration of the German situation concerning plasma derivatives is impossible due to complex trade and manufacture in various federal states. Assessment of the supply situation is further impaired by missing data from users. Regarding haemophilia treatment, an improvement is intended by establishing a German Haemophilia Register.

Bericht zur Meldung nach § 21 TFG für die Jahre 2008 und 2009@@@Report on notifications pursuant to Section 21 of the German Transfusion Act for the years 2008 and 2009

This report contains the data collected in 2008 and 2009, pursuant to Section 21 of the German Transfusion Act (Transfusionsgesetz), 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 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 red blood cell 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, and--what is noteworthy--especially 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 of blood components for transfusion can be regarded as assured. Nearly 2.9 million liters of plasma for fractionation were collected in Germany in 2009. According to reports from the pharmaceutical industry, of these, 2.6 million liters remained on the German market, of which only 56% were fractionated in this country; no statement can be made on the use of the remaining amount. Many plasma derivatives are not manufactured in Germany, despite the large amount of plasma collected. The supply with these products, however, is assured by imports. Overall, 16,409 autologous and 9,435 allogeneic hematopoietic stem cell preparations were manufactured in 2009, of which 3,382 allogeneic preparations were exported. A total of 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 stem cells suggest that no serious shortages are to be expected for the supply with these products.

Bericht zur Meldung nach § 21 TFG für das Jahr 2007@@@Report on notifications pursuant to Section 21 German Transfusion Act for 2007

The present report contains the data collected in 2007, pursuant to Section 21 German Transfusion Act, and an analysis of the supply situation over the past 8 years. As in previous years, all blood donation centres located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion. According to these data, a total of 6.7 million blood collections were performed in 2007. With 4.7 million, the portion of whole blood donations was at the level of previous years, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decay of red blood cell concentrates on the user side in 2000 accounted for 5% while in 2007 it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas, too, markedly increased in 2007 (to 1.2 million transfusion units). In 2007, 2.2 million I of plasma for fractionation were collected in Germany. In addition, 1.0 million I were imported, and 1.8 million I were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million I was almost entirely allocated to basic fractionation so that a sufficient plasma supply can be assumed. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 I of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for haematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700. A large portion of this (1,810 transplants) could be exported while only a small number (179 preparations) had to be imported. The manufacture of autologous stem cell preparations from cord blood has risen drastically to more than 10,000 in 2007. The interest in the figures collected in compliance with Section 21, German Transfusion Act remains high both in Germany and at an international level. Meanwhile reliable data are available.The present report contains the data collected in 2007, pursuant to Section 21 Transfusionsgesetz (German Transfusion Act), and an analysis of the supply situation over the past eight years. The recording of the data by online reporting is in the meantime well established and generally accepted. As in previous years, all blood donation centers located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion, so that meaningful data are available. According to these data, a total of 6.7 million blood collections were performed in 2007. The number of whole blood donations was at the level of previous years, with 4.7 million, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decrease in the portion of decay of red blood cell concentrates on the user side is particularly good news. In 2000, it accounted for 5% and in 2007, it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas also markedly increased in 2007 compared with previous years, accounting for 1.2 million transfusion units. In 2007, 2.2 million liters of plasma for fractionation were collected in Germany. This trend went hand in hand with the increasing number of apheresis donations that year. In addition, 1.0 million liters were imported, and, at the same time, 1.8 million liters were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million liters was almost entirely allocated to basic fractionation, so that a sufficient plasma supply can be assumed. The assessment of the degree of self-sufficiency is made difficult because of the influence of imports and exports; however, the results show no deficit for plasma derivatives. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 liters of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for hematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700 in the reporting year. A large portion of this, 1,810 transplants could be exported while only a small number, 179 preparations, had to be imported. The manufacture of autologous stem cell preparations from cord blood also rose drastically compared with 2006, to more than 10,000 in 2007. It must be emphasized that these products were entirely placed into stock; none were transplanted in the reporting year. The interest in the figures collected in compliance with Section 21, Transfusion Act remains high both in Germany and at the international level. Reliable data are available thanks to the evaluations of trends over years, above all on the availability of blood components for transfusion. In addition, the Paul Ehrlich Institute will continue to strive to meet the demands for high-quality information on the supply situation in the future.

Developing a German Hemophilia Register

In December 2004, the development of a draft to establish the Deutsches Hamophilieregister (DHR, German Hemophilia Register) was initiated at the Paul- Ehrlich-Institut with the start-up financing by the Federal Ministry of Health (BMG). Extensive discussions were held with hemophilia treaters, patients’ organizations, and other interested parties with the BMG taking the chair. The outcome of these talks was that the DHR should be operated as a joint activity of the patients’ organization DHG (Deutsche Hamophiliegesellschaft zur Bekampfung von Blutungskrankheiten), the IGH (Interessengemeinschaft Hamophiler), the GTH (Organization for Thrombosis and Hemostasis Research) and the Paul- Ehrlich-Institut. The parties involved expressed their confidence in the PEI as an “independent organization”, and conferred upon it the responsibility establishing the DHR and its technical location at the PEI.