The European Commission has published two reports on the implementation of EU legislation which sets standards of quality and safety for both human blood and human tissues and cells.
According to the legislation, donations of human blood, tissues and cells should be voluntary and unpaid and all EU countries have taken measures to encourage this, although what is considered compensation and incentive vary between Member States.
The reports also point to some gaps and difficulties in applying and enforcing the rules. For both sectors, these difficulties relate to such things as the protection of donors, the inspections framework and testing and deferral criteria for new epidemiological and technological developments (eg testing for Malaria).
For more information, including links to both reports, on the ec.europa.eu website.
The World Health Organisation (WHO) and the Council of Europe, along with 8 other partners are supporting the ‘ACCORD’ project which has involved 23 European countries. “Achieving Comprehensive Coordination in Organ Donation throughout the European Union” is a Joint Action coordinated by the Spanish National Transplant Organisation and aims to narrow the inequalities in organ donation by:
- Enhancing the protection of living donors by improving information systems and through common standards.
- Promoting deceased organ donation by facilitating the cooperation between critical care professionals and donor transplant coordinators.
- Sharing practical knowledge, expertise and tools by implementing practical collaborations among countries – through a “twinnings” initiative.
For more information about ACCORD, click here on www.accord-ja.eu
The Commission has adopted two sets of rules for human tissues and cells to protect patients in the EU by ensuring high quality and safety standards.
The first set of rules set out the technical requirements that will facilitate tracing of all tissues and cells between donor and recipient. This will happen through a so-called ‘Single European Code’ and a Commission-hosted IT-platform to ensure uniform labelling of all tissues and cells distributed in the EU. In the case of a safety alert, this label will ensure that all recipients who received material from the same donor can be traced and treated as needed. It will also allow for unused tissues or cells to be discarded.
The second directive covers imports and sets out procedures for ensuring that tissues and cells imported from third countries meet the same safety and quality standards as those procured, processed and distributed in the EU. These rules will ensure the safety of EU recipients in need of tissues and cells, regardless of the origin of the material.
For more information, click here on http://ec.europa.eu
The European Union has agreed a common approach to facilitate comparisons between data sent to the Commission from member states on adverse events and reactions to blood and blood components.
These guidelines should reduce the burden of reporting by clarifying issues before data is collected each year.
To read more about the guidelines, click here on www.ec.europa.eu