Annexes to COM(2011)138 - 2nd Report on Voluntary and Unpaid Donation of Blood and Blood Components

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agreements/collaboration structures to ensure appropriate supply of blood and blood components at a national level.

SUMMARY AND CONCLUDING REMARKS

This report shows that Member States overall comply with Article 20(1) of Directive 2002/98/EC, requiring Member States to take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensure that blood and blood components are in so far as possible provided from such donation.

Largely in line with the findings of the first report on voluntary and unpaid blood donation (issued 2006), this report shows that legislative provisions and guidelines on voluntary and unpaid blood donation are well established across the EU. All but one of the 29 reporting countries have such provisions in place.

Most reporting countries have some form of incentive structures for blood donors, such as refreshments, small token and reimbursement of travel costs. Several countries also offer blood donors employed in the public sector time off work. The study indicates that there are no major differences in incentives for whole blood donors and apheresis (plasma, platelets…) donors.

27 out of the 29 reporting countries have undertaken some form of measures to promote voluntary and unpaid blood donation, such as awareness raising and information campaigns.

Concerning collection and supply of blood and blood components, the report shows that collectors/suppliers of whole blood and plasma are predominately public in the EU, Norway and Croatia. About half of the reporting countries have the capacity for plasma fractionation. In these countries, actors in the field of plasma fractionation are mainly private (71%). With regards to supply, the Competent Authorities for blood and blood components report relatively limited shortages of blood and blood components, ranging from around 14% (for whole blood) to 0% for white blood cells. About 75% of the countries have policies in place to contain or ensure the effective clinical use of blood, as well as to promote self-sufficiency of blood and blood components.

Based on the findings of the report, the Commission will now, together with the Member States, reflect on the potential need for further measures, keeping in mind that the Commission's mandate is limited to quality and safety of blood and blood components.

[1] Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.

[2] COM(2006)217 final, Report on the promotion by Member States of voluntary unpaid blood donations.

[3] http://ec.europa.eu/health/blood_tissues_organs/docs/blood_mi_20101027_en.pdf.

[4] Directive 2002/98/EC defines blood as "whole blood collected from a donor and processed either for transfusion or for further manufacturing", and blood components as "therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods".