Vistart

Expected outcomes

At the close of the Joint Action, there will have been significant changes in the way in which EU Competent Authorities for blood, tissues and cells approach their inspection, authorisation and vigilance responsibilities.

Procedures for inspection and authorisation of blood and tissue establishments will have been harmonised allowing much greater efficiency and consistency. In some cases, smaller or less developed Member States will have strengthened their inspection programmes through collaboration with inspectorates from neighboring or more advanced Member States. Blood, tissue and cell inspectors will be trained in a more harmonised way and will have created a stronger network. Vigilance will be managed by Competent Authorities in a manner that is consistent across these substances of human origin. Some types of rapid alerts that are common for the blood and tissue and cell sectors, such as epidemic infection outbreaks, toxic culture media, defective lab instruments and preservation bags, etc. will be communicated via a common rapid alert avoiding a double reporting to CAs that are responsible for both of these sectors. In addition, a common handling of these events will accelerate efficient and uniform solutions and an agreed content of the communications/alert messages to health care professionals, to health institutions and to patients in Europe. New risks associated with emerging diseases will be considered for all of these substances, using the extensive historical expertise of the blood transfusion field to make tissue and cell applications safer. Competent Authorities for the safety and quality of these substances will share principles regarding their expectations for patient follow up, when novel processing methods are introduced. The WHO Notify Library of adverse occurrences in transfusion, transplantation and assisted reproduction will be enhanced with didactic cases provided by EU Competent Authorities. Member States will have implemented the Single European Code for Tissues and Cells in compliance with the revised Directive 2006/86/EC.