Division 3.2.2.2 Safety of blood, tissues, cells, organs (Annex — Point 1.2.2)

Specific questions related to blood, tissues, cells and organs remain on the promotion of voluntary unpaid donations, inspections, electronic exchange of data and optimal use. For the implementation of the tissues and cells directives traceability, coding and reporting systems for adverse events should be established at community level. There is a need to support projects that help in managing import and export, registers and reporting obligations of the directives. Stem cells, reproductive cells and new human derivatives are special cases that will require specific attention. On organs, improving quality and safety, increasing organ availability and making transplantation systems more efficient and accessible will require further work following the Commission Communication on organ donation and transplantation.

In 2008, the following projects will be prioritised:

• Evaluation of post transplant results on organ transplantation: Promote common definitions of terms and methodology to evaluate the results of transplantation. Promote register or network of registers to follow-up on organ recipients, monitor their health and evaluate results. [Financing mechanism: Call for proposals]

• Analysis and comparison of the validation and certification of testing methods and testing laboratories in the EU and third countries for the biological markers specified in the blood and tissues and cells Directives. Implications on import and exports of blood, blood components, tissues and cells from and in the third countries [Financing mechanism: Call for tender]

• Ad hoc cooperation with the Council of Europe on specific matters related to human substances (blood, tissues, cells, organs). [Financial mechanism: Direct grant agreement with CoE]